Find a Treatment Center
Use this option to find a Treatment Center near you
Select any filter and click on Apply to see results
MDSI: Depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions.
Real People.
Really Inspiring Stories.
These are real patients or caregivers of patients with treatment-resistant depression. They have been compensated for their time by Janssen Pharmaceuticals, Inc.
Nicole’s Story
Ben’s Story
Allison’s
Caregiver Story
Amy’s Story
Grace’s Story
Sally’s Story
These are real patients or caregivers of patients with treatment-resistant depression. They have been compensated for their time by Janssen Pharmaceuticals, Inc.
View video transcript
Nicole: There were days where I would just break down crying in my bathroom because I just couldn’t do it. I couldn’t get up. I couldn’t take a shower. I couldn’t physically do anything.
SUPER: Nicole’s Story
SUPER:
Nicole
Age 23 | Missouri
SUPER: Nicole, 23, is a real patient with treatment-resistant depression and has been compensated for her time by Janssen Pharmaceuticals, Inc.
Nicole: It was bad. I was kind of cruel towards my mom at times. And there were points where she would just cry because of things I said or things I did. And I didn’t understand that I was being cruel. I didn’t understand that at all. I just lashed out. I ended up going to college. I stayed for about two months. Semester started in August. I dropped out and was home before Halloween. I would sleep 18 to 20 hours a day. I wouldn’t shower for three months. It was crazy. I was getting worse over time. I was having a lot more negative thoughts about myself. And so all these negative thoughts about how I just failed—I failed as a person, I failed myself, I failed my mom, I failed my teachers.
It kind of spirals, to the point where I really hated myself. And I remember thinking, “But I just want to fall asleep and never wake up again.” I walked in to my current psychiatrist with a legitimate page and a half full of medicines that I’d already tried that didn’t work. We found out that I have treatment-resistant depression. At some point, my psychiatrist talked to me about this medical trial study for SPRAVATO®. It really does help with treatment-resistant depression.
SUPER: Individual results may vary.
Speaker/SUPER: SPRAVATO® is the first FDA-approved nasal spray, taken along with an oral antidepressant, for adults with treatment-resistant depression. It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions. SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®. SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic) and it is not for use in children. SPRAVATO® can cause serious side effects including sleepiness, fainting, dizziness, spinning sensation, anxiety or feeling disconnected from yourself, your thoughts, feelings or things around you. Your healthcare provider will monitor you for at least two hours after taking SPRAVATO®. Please see additional Important Safety Information later in this video.
Nicole: Sometimes with depression, not only do you feel it emotionally, it feels like a weight. I was just so light. That was something so new to me.
SUPER: In a clinical study of adults with treatment-resistant depression, those who took SPRAVATO® and an oral antidepressant experienced a greater reduction of depressive symptoms at four weeks compared to those who received a placebo plus an oral antidepressant.
Nicole: When I was truly in my throes of depression, I would start every day off at like a negative six versus a zero. After I started taking SPRAVATO®, I’m starting off the day waking up neutral, which is the best. My mom is my best friend. She is the best. And she has sacrificed her entire life for me and she’s so good. And she is. I’m actually just finishing up my first semester. Eventually, I want to transfer out of my community college. I’m learning so much stuff and I’m growing as a person. So it’s awesome.
I’m 23 now and I’m almost 24, and I never thought I would live to be 24. I just have so many opportunities. It’s awesome.
Speaker/SUPER:
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SPRAVATO®?
SPRAVATO® can cause serious side effects, including:
-
Sedation and dissociation. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).
- Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out.
- Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting.
-
Abuse and misuse. There is a risk for abuse and physical and psychological dependence with SPRAVATO® treatment. Your healthcare provider should check you for signs of abuse and dependence before and during treatment with SPRAVATO®.
- Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
- Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
- SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (e.g., medical offices and clinics) must be enrolled in the program.
-
Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.
SPRAVATO® is not for use in children
- Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.
-
How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
- Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
- Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.
-
Tell your healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:
- suicide attempts
- thoughts about suicide or dying
- worsening depression
- other unusual changes in behavior or mood
Do not take SPRAVATO® if you:
- have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs)
- have an abnormal connection between your veins and arteries (arteriovenous malformation)
- have a history of bleeding in the brain
- are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO®.
If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®.
Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you:
-
have heart or brain problems, including:
- high blood pressure (hypertension)
- slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting
- history of heart attack
- history of stroke
- heart valve disease or heart failure
- history of brain injury or any condition where there is increased pressure in the brain
- have liver problems
- have ever had a condition called “psychosis” (see, feel, or hear things that are not there, or believe in things that are not true).
-
are pregnant or plan to become pregnant. SPRAVATO® may harm your baby. You should not take SPRAVATO® if you are pregnant.
- Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO®.
- If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO®.
- There is a pregnancy registry for women who are exposed to SPRAVATO® during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO® and their baby. If you become pregnant during treatment with SPRAVATO®, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
- are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with SPRAVATO®.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO® with certain medicine may cause side effects.
Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How will I take SPRAVATO®?
- You will take SPRAVATO® nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device.
- Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it.
- Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to.
- During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting.
- You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®.
- If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule.
- Some people taking SPRAVATO® get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO® and not drink liquids at least 30 minutes before taking SPRAVATO®.
- If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO®.
What should I avoid while taking SPRAVATO®?
Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See “What is the most important information I should know about SPRAVATO®?”
What are the possible side effects of SPRAVATO®?
SPRAVATO® may cause serious side effects including:
- See “What is the most important information I should know about SPRAVATO®?”
- Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®.
- Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering.
- Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.
The most common side effects of SPRAVATO® when used along with an antidepressant taken by mouth include:
- feeling disconnected from yourself, your thoughts, feelings and things around you
- dizziness
- nausea
- feeling sleepy
- spinning sensation
- decreased feeling of sensitivity (numbness)
- feeling anxious
- lack of energy
- increased blood pressure
- vomiting
- feeling drunk
- feeling very happy or excited
If these common side effects occur, they usually happen right after taking SPRAVATO® and go away the same day.
These are not all the possible side effects of SPRAVATO®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO® at SPRAVATO.com and discuss any questions you may have with your healthcare provider.
SUPER:
cp-79822v3
SUPER:
© Janssen Pharmaceuticals, Inc. 2021. All rights reserved. 08/21 cp-72100v5
“When I was truly in my throes of depression, I would start every day off at like a negative six versus a zero. After I started taking SPRAVATO®, I’m starting off the day waking up neutral, which is the best.”
Nicole P.; St. Peters, Missouri
Nicole, 23,* is a real patient with treatment-resistant depression and has been compensated for her time and testimonial by Janssen Pharmaceuticals, Inc. Individual results may vary.
*Testimonial filmed in 2018.
Click here to watch the next video
View video transcript
Ben: This internal voice wants to convince me that I’m a terrible person, that I don’t know what I’m doing, that nobody likes me, that I’m a literal piece of garbage who doesn’t deserve anything.
SUPER: BEN’S STORY
SUPER:
Ben
Age 40 | New York
SUPER: Ben is a real patient with treatment-resistant depression and has been compensated for his time by Janssen Pharmaceuticals, Inc.
Ben: My depression was picking up more in my thirties. When you’re going through that spiral, you can’t see your hand in front of your face. You’re lost in the mess and it’s just like everything’s wrong. And I wouldn’t be able to function.
Some days I would just collapse in a fit of crying. Probably on only 5 hours of sleep a week, not eating enough. That’s when things were the worst. I tried at least four oral antidepressants.
My psychiatrist told me treatment-resistant depression is something that I had. And there were other options for this. From the research, from what I talk to with my psychiatrist, everything pointed to oral antidepressant, plus the SPRAVATO®. So I was like, yeah, let’s do it.
Speaker/SUPER: SPRAVATO® is the first FDA-approved nasal spray, taken along with an oral antidepressant, for adults with treatment-resistant depression.
It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions.
SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®.
SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic) and it is not for use in children.
SPRAVATO® can cause serious side effects including sleepiness, fainting, dizziness, spinning sensation, anxiety or feeling disconnected from yourself, your thoughts, feelings or things around you (dissociation).
Your healthcare provider will monitor you for at least two hours after taking SPRAVATO®.
Please see additional Important Safety Information later in this video.
Ben: I was learning to love myself each and every session.
SUPER: In a clinical study of adults with treatment-resistant depression, those who took SPRAVATO® and an oral antidepressant experienced a greater reduction of depressive symptoms at four weeks compared to those who received a placebo plus an oral antidepressant.
Ben: I like to have people over. I like to cook. Love to hike and camp. I love running. I run almost daily.
SUPER: Individual results may vary.
Ben: I’m like really proud of where I am now. And I couldn’t have done this without my friends, definitely not without my family, and especially not without SPRAVATO®. It didn’t make me a new person. It helped me become Ben.
Speaker/SUPER:
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SPRAVATO®?
SPRAVATO® can cause serious side effects, including:
-
Sedation and dissociation. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).
- Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out.
- Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting.
-
Abuse and misuse. There is a risk for abuse and physical and psychological dependence with SPRAVATO® treatment. Your healthcare provider should check you for signs of abuse and dependence before and during treatment with SPRAVATO®.
- Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
- Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
- SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (e.g., medical offices and clinics) must be enrolled in the program.
-
Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.
SPRAVATO® is not for use in children
- Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.
-
How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
- Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
- Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.
-
Tell your healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:
- suicide attempts
- thoughts about suicide or dying
- worsening depression
- other unusual changes in behavior or mood
Do not take SPRAVATO® if you:
- have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs)
- have an abnormal connection between your veins and arteries (arteriovenous malformation)
- have a history of bleeding in the brain
- are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO®.
If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®.
Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you:
-
have heart or brain problems, including:
- high blood pressure (hypertension)
- slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting
- history of heart attack
- history of stroke
- heart valve disease or heart failure
- history of brain injury or any condition where there is increased pressure in the brain
- have liver problems
- have ever had a condition called “psychosis” (see, feel, or hear things that are not there, or believe in things that are not true).
-
are pregnant or plan to become pregnant. SPRAVATO® may harm your baby. You should not take SPRAVATO® if you are pregnant.
- Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO®.
- If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO®.
- There is a pregnancy registry for women who are exposed to SPRAVATO® during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO® and their baby. If you become pregnant during treatment with SPRAVATO®, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
- are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with SPRAVATO®.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO® with certain medicine may cause side effects.
Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How will I take SPRAVATO®?
- You will take SPRAVATO® nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device.
- Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it.
- Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to.
- During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting.
- You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®.
- If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule.
- Some people taking SPRAVATO® get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO® and not drink liquids at least 30 minutes before taking SPRAVATO®.
- If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO®.
What should I avoid while taking SPRAVATO®?
Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See “What is the most important information I should know about SPRAVATO®?”
What are the possible side effects of SPRAVATO®?
SPRAVATO® may cause serious side effects including:
- See “What is the most important information I should know about SPRAVATO®?”
- Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®.
- Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering.
- Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.
The most common side effects of SPRAVATO® when used along with an antidepressant taken by mouth include:
- feeling disconnected from yourself, your thoughts, feelings and things around you
- dizziness
- nausea
- feeling sleepy
- spinning sensation
- decreased feeling of sensitivity (numbness)
- feeling anxious
- lack of energy
- increased blood pressure
- vomiting
- feeling drunk
- feeling very happy or excited
If these common side effects occur, they usually happen right after taking SPRAVATO® and go away the same day.
These are not all the possible side effects of SPRAVATO®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO® at SPRAVATO.com and discuss any questions you may have with your healthcare provider.
SUPER:
cp-79822v3
SUPER:
© Janssen Pharmaceuticals, Inc. 2023. All rights reserved. 07/23 cp-374310v1
“I’m really proud of where I am now. And I couldn’t have done this without SPRAVATO®. It didn’t make me a new person. It helped me become Ben.”
Ben L.; Brooklyn, New York
Ben, 40,* is a real patient with treatment-resistant depression and has been compensated for his time and testimonial by Janssen Pharmaceuticals, Inc. Individual results may vary.
*Testimonial filmed in 2023.
Click here to watch the next video
View video transcript
Allison: All of my effort, all of my attention went to him and finding the right treatment. To have tried everything and to know he’s not getting better, that was very difficult.
SUPER:
A Caregiver’s Story
About Treatment-Resistant Depression
SUPER:
Allison
Pikeville, Kentucky
SUPER: Allison is a real caregiver for her adult son with treatment-resistant depression and is an employee of Janssen Pharmaceutical Companies of Johnson & Johnson.
Allison: He was just a very sensitive child. My son would not ever want a balloon because he knew it wouldn’t last. So if he lost it, he would start immediately crying. And high school, that’s when we really started seeing the depression. He started sleeping more, wrecking his room, not wanting to go to school. I actually had a truancy officer come and visit me. So you’re talking about a straight-A student that got a scholarship from the University of Kentucky that was now in danger of failing his senior year. So we got with this psychologist and talked to her and she recommended that he might need to start on some sort of medication.
He tried around seven or eight and different combinations of oral medications, after like two, three months, they would just fail. Nothing seemed to work. He was getting ready to move away to go to school, and I was going to have to say goodbye to him and watch him leave the nest when I knew he was really not well. I was a worried mama. I spent a lot of time on the road going back and forth to make sure he was okay. I would go and check on him and, you know, his room would be a mess, and he would be a mess, and he would be sleeping all the time. When a person has treatment-resistant depression, they really aren’t taking care of themselves. And it’s not that they don’t want to, it’s just they’re in this cycle and they don’t know how to get out of it. I spent a lot of time on the phone, you know, talking to a psychologist, talking to the psychiatrist about what we were going to do next because he wasn’t getting any better. In fact, he was getting worse.
I had four other kids at home, and I wasn’t able to give them the attention, love, whatever they needed, which hurts me because, you know, I do love my children very much. So, a lot of those drives were spent in tears. You feel hopeless and helpless. It’s your baby. No matter how old they are, that’s still your baby. After he had been in school for a little while, I got the call that every mother dreads: he had tried to commit suicide. And, you know, it’s one of those things that—it’s surreal, you just can’t imagine your life without your child. But treatment-resistant depression is a disease, just like diabetes or anything else. I mean, you just have to keep going, because it’s your child’s life. Luckily SPRAVATO® came out when it did.
Speaker/SUPER: SPRAVATO® is the first FDA-approved nasal spray, taken along with an oral antidepressant, for adults with treatment-resistant depression. It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions. SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®. SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic) and it is not for use in children. SPRAVATO® can cause serious side effects including sleepiness, fainting, dizziness, spinning sensation, anxiety or feeling disconnected from yourself, your thoughts, feelings or things around you. Your healthcare provider will monitor you for at least two hours after taking SPRAVATO®. Please see additional Important Safety Information later in this video.
Allison: So, after a few weeks, his symptoms started to improve and his hygiene got better. He started calling me on the phone more, he became interested in gardening and cooking.
SUPER: In a clinical study of adults with treatment-resistant depression, those who took SPRAVATO® and an oral antidepressant experienced a greater reduction of depressive symptoms at four weeks compared to those who received a placebo plus an oral antidepressant.
Individual results may vary.
Allison: He composts, he has pumpkins, he has spinach, he has blueberries. Anytime that he gets off from work, he’s out working in his garden. In addition to the SPRAVATO®, he’s taken an oral antidepressant. My son is 22 now. He’s doing so much better. He’s working in a restaurant. He aspires to go to chef school soon. And I was able to get my mind off of just him. I’m there for my kids more; I’m there for my husband.
The misconception is you should be able to pull yourself up by the bootstraps and just be able to get yourself out of it, and that’s simply not true. You have to have a team and you have to have the right medications to carry on. When somebody has treatment-resistant depression, it’s easy for them to lose hope, so you have to be that hope for them. I think the future is very bright for my son. I think he’s going to be a renowned chef. I mean, that’s my hopes for him, but most of all, I want him to be happy. There is hope out there. I’ve gotten my son back.
Speaker/SUPER:
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SPRAVATO®?
SPRAVATO® can cause serious side effects, including:
-
Sedation and dissociation. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).
- Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out.
- Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting.
-
Abuse and misuse. There is a risk for abuse and physical and psychological dependence with SPRAVATO® treatment. Your healthcare provider should check you for signs of abuse and dependence before and during treatment with SPRAVATO®.
- Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
- Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
- SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (e.g., medical offices and clinics) must be enrolled in the program.
-
Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.
SPRAVATO® is not for use in children
- Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.
-
How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
- Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
- Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.
-
Tell your healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:
- suicide attempts
- thoughts about suicide or dying
- worsening depression
- other unusual changes in behavior or mood
Do not take SPRAVATO® if you:
- have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs)
- have an abnormal connection between your veins and arteries (arteriovenous malformation)
- have a history of bleeding in the brain
- are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO®.
If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®.
Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you:
-
have heart or brain problems, including:
- high blood pressure (hypertension)
- slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting
- history of heart attack
- history of stroke
- heart valve disease or heart failure
- history of brain injury or any condition where there is increased pressure in the brain
- have liver problems
- have ever had a condition called “psychosis” (see, feel, or hear things that are not there, or believe in things that are not true).
-
are pregnant or plan to become pregnant. SPRAVATO® may harm your baby. You should not take SPRAVATO® if you are pregnant.
- Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO®.
- If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO®.
- There is a pregnancy registry for women who are exposed to SPRAVATO® during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO® and their baby. If you become pregnant during treatment with SPRAVATO®, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
- are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with SPRAVATO®.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO® with certain medicine may cause side effects.
Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How will I take SPRAVATO®?
- You will take SPRAVATO® nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device.
- Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it.
- Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to.
- During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting.
- You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®.
- If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule.
- Some people taking SPRAVATO® get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO® and not drink liquids at least 30 minutes before taking SPRAVATO®.
- If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO®.
What should I avoid while taking SPRAVATO®?
Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See “What is the most important information I should know about SPRAVATO®?”
What are the possible side effects of SPRAVATO®?
SPRAVATO® may cause serious side effects including:
- See “What is the most important information I should know about SPRAVATO®?”
- Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®.
- Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering.
- Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.
The most common side effects of SPRAVATO® when used along with an antidepressant taken by mouth include:
- feeling disconnected from yourself, your thoughts, feelings and things around you
- dizziness
- nausea
- feeling sleepy
- spinning sensation
- decreased feeling of sensitivity (numbness)
- feeling anxious
- lack of energy
- increased blood pressure
- vomiting
- feeling drunk
- feeling very happy or excited
If these common side effects occur, they usually happen right after taking SPRAVATO® and go away the same day.
These are not all the possible side effects of SPRAVATO®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO® at SPRAVATO.com and discuss any questions you may have with your healthcare provider.
SUPER:
cp-79822v3
SUPER:
© Janssen Pharmaceuticals, Inc. 2021. All rights reserved. 09/21 cp-191060v2
“My son is 22* now. He’s doing so much better.”
Allison F.; Pikeville, Kentucky
Caregiver for son with treatment-resistant depression
Allison is a real caregiver for her adult son with treatment-resistant depression. She is an employee of Janssen Pharmaceutical Companies of Johnson & Johnson. Individual results may vary.
*Testimonial filmed in 2021.
Click here to watch the next video
View video transcript
Amelia: I felt like the depression just robbed me of, of everything.
I mean, it almost robbed me of my life.
SUPER:
AMELIA’S STORY
SUPER:
Amelia
Age 52 | Minnesota
SUPER: Amelia is a real patient with treatment-resistant depression and has been compensated for her time by Janssen Pharmaceuticals, Inc.
Amelia: It’s like these monsters were in the basement of my house, banging at the door to try to get into the rest of the house and to me and, like, destroy me. So I always felt like I was trying to suppress that depression.
I couldn’t do things that I normally would have liked to do, like art and writing. I tried multiple oral antidepressants and those weren’t working. So for my doctor to say, you have treatment-resistant depression, it wasn’t really a surprise. I really, I did think about taking my life and how, how it would be so much better to feel nothing.
SUPER: There are no approved therapeutic options for prevention of suicide or reduction of suicidal thoughts or actions.
Amelia: My doctor started talking about these new ways to help people with treatment-resistant depression like SPRAVATO®. I was, I was hopeful about this.
Speaker/SUPER: SPRAVATO® is the first FDA-approved nasal spray, taken along with an oral antidepressant, for adults with treatment-resistant depression.
It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions.
SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®.
SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic) and it is not for use in children.
SPRAVATO® can cause serious side effects including sleepiness, fainting, dizziness, spinning sensation, anxiety or feeling disconnected from yourself, your thoughts, feelings or things around you (dissociation).
Your healthcare provider will monitor you for at least two hours after taking SPRAVATO®.
Please see additional Important Safety Information later in this video.
SUPER: In a clinical study of adults with treatment-resistant depression, those who took SPRAVATO® and an oral antidepressant experienced a greater reduction of depressive symptoms at four weeks compared to those who received a placebo plus an oral antidepressant.
Individual results may vary.
Amelia: I felt like I was waking up from depression, like I had been trapped in one part of my mind for a long time and now I’m going outside, I’m talking to the neighbors, I’m walking my dog. I had access to myself, my creativity. It’s like I could see the world around me, like how beautiful the people in my life were.
SUPER: If you’re experiencing suicidal thoughts, call your healthcare provider right away or call the National Suicide Prevention Lifeline at 1-800-273-8255.
Amelia: I really want people to know that even if oral antidepressants didn’t work for them, they should not give up. If I could have had SPRAVATO® years ago, that would have been wonderful. I’m living life definitely to its fullest now.
Speaker/SUPER:
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SPRAVATO®?
SPRAVATO® can cause serious side effects, including:
-
Sedation and dissociation. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).
- Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out.
- Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting.
-
Abuse and misuse. There is a risk for abuse and physical and psychological dependence with SPRAVATO® treatment. Your healthcare provider should check you for signs of abuse and dependence before and during treatment with SPRAVATO®.
- Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
- Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
- SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (e.g., medical offices and clinics) must be enrolled in the program.
-
Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.
SPRAVATO® is not for use in children
- Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.
-
How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
- Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
- Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.
-
Tell your healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:
- suicide attempts
- thoughts about suicide or dying
- worsening depression
- other unusual changes in behavior or mood
Do not take SPRAVATO® if you:
- have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs)
- have an abnormal connection between your veins and arteries (arteriovenous malformation)
- have a history of bleeding in the brain
- are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO®.
If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®.
Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you:
-
have heart or brain problems, including:
- high blood pressure (hypertension)
- slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting
- history of heart attack
- history of stroke
- heart valve disease or heart failure
- history of brain injury or any condition where there is increased pressure in the brain
- have liver problems
- have ever had a condition called “psychosis” (see, feel, or hear things that are not there, or believe in things that are not true).
-
are pregnant or plan to become pregnant. SPRAVATO® may harm your baby. You should not take SPRAVATO® if you are pregnant.
- Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO®.
- If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO®.
- There is a pregnancy registry for women who are exposed to SPRAVATO® during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO® and their baby. If you become pregnant during treatment with SPRAVATO®, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
- are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with SPRAVATO®.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO® with certain medicine may cause side effects.
Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How will I take SPRAVATO®?
- You will take SPRAVATO® nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device.
- Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it.
- Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to.
- During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting.
- You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®.
- If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule.
- Some people taking SPRAVATO® get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO® and not drink liquids at least 30 minutes before taking SPRAVATO®.
- If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO®.
What should I avoid while taking SPRAVATO®?
Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See “What is the most important information I should know about SPRAVATO®?”
What are the possible side effects of SPRAVATO®?
SPRAVATO® may cause serious side effects including:
- See “What is the most important information I should know about SPRAVATO®?”
- Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®.
- Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering.
- Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.
The most common side effects of SPRAVATO® when used along with an antidepressant taken by mouth include:
- feeling disconnected from yourself, your thoughts, feelings and things around you
- dizziness
- nausea
- feeling sleepy
- spinning sensation
- decreased feeling of sensitivity (numbness)
- feeling anxious
- lack of energy
- increased blood pressure
- vomiting
- feeling drunk
- feeling very happy or excited
If these common side effects occur, they usually happen right after taking SPRAVATO® and go away the same day.
These are not all the possible side effects of SPRAVATO®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO® at SPRAVATO.com and discuss any questions you may have with your healthcare provider.
SUPER:
cp-79822v3
SUPER:
© Janssen Pharmaceuticals, Inc. 2023. All rights reserved. 07/23 cp-374309v1
“I really want people to know that even if oral antidepressants didn’t work for them, they should not give up.”
Amelia M.; Edina, Minnesota
Amelia, 52,* is a real patient with treatment-resistant depression and has been compensated for her time and testimonial by Janssen Pharmaceuticals, Inc. Individual results may vary.
*Testimonial filmed in 2023.
Click here to watch the next video
View video transcript
Grace: I remember sitting down in the shower one time and just bawling my eyes out until the water went cold. And then, even after the water went cold, I just sat there, bawling.
SUPER: GRACE’S STORY
Grace: College was incredibly difficult for me. Everything becomes such a colossal challenge with depression
SUPER:
Grace
Age 29 | Colorado
SUPER: Grace is a real patient with treatment-resistant depression and has been compensated for her time by Janssen Pharmaceuticals, Inc.
Grace: I would sit there in class and just feel so uncomfortable and... I felt like I was crawling out of my skin at every second. I was absolutely miserable and I was too afraid to tell anyone because how can you be miserable in college? It’s supposed to be the best. I just could not understand why I wasn’t having the same experience that everyone else was. I don’t know if I was really even aware of how unhappy I truly was. Because I was just focused on pretending. My smile was fake, and my laughing was fake, and all of those pictures were fake. And pretending to be happy when you’re not just takes the life out of you.
Grace: Depression doesn’t steal everything in one fell swoop; it, it takes things little by little. At first, I wouldn’t want to go out one night, and then I wouldn’t want to go out at all. I wouldn’t feel like going to the gym that one day, and then I just wouldn’t go ever. And I was trying all different kinds of medications. I think, at this point, I’m at 16 different antidepressants that I’ve tried. It even got to the point that I tried electric convulsive therapy. The worst part about that was that it didn’t work. That was one new low for me... and after that, I was truly and utterly lost. I just remember... sitting there, talking to my mom and just telling her that I was going to be this unhappy forever and that seemed like an insurmountable obstacle to tackle.
SUPER: If you’re experiencing suicidal thoughts, call your healthcare provider right away or call the National Suicide Prevention Lifeline at 1-800-273-8255
Grace: Hope is something incredibly difficult to maintain when you have depression. Hope can be poison. You start a new medication and you feel hopeful ... and then ... it doesn’t work and your heart’s broken. And 16 medications and 16 heartbreaks later ... it seems ludicrous to put yourself in that position again. But what is your other option? You know, either you keep trying or you live in the hell that you’re in for the rest of your life.
Grace: I read about a medication called SPRAVATO® and the more that I read, the more reluctantly hopeful I became.
Speaker/SUPER: SPRAVATO® is the first FDA-approved nasal spray, taken along with an oral antidepressant, for adults with treatment-resistant depression. It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions. SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®. SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic) and it is not for use in children. SPRAVATO® can cause serious side effects including sleepiness, fainting, dizziness, spinning sensation, anxiety or feeling disconnected from yourself, your thoughts, feelings or things around you (dissociation). Your healthcare provider will monitor you for at least two hours after taking SPRAVATO®. Please see additional Important Safety Information later in this video.
Grace: So I didn’t notice right away but my family did. My mom would say that she would see me smiling more. Or my boyfriend would say that he had heard me laugh for the first time in far too long.
SUPER: In a clinical study of adults with treatment-resistant depression, those who took SPRAVATO® and an oral antidepressant experienced a greater reduction of depressive symptoms at four weeks compared to those who received a placebo plus an oral antidepressant.
SUPER: Individual results may vary.
Grace: And then I slowly started to realize it. It’s so cliché to say this, but it’s really like a veil had lifted. I started realizing that I was getting better when I wanted to do things—I wasn’t forcing myself to do them.
Grace: The most amazing feeling to be able to just, just sit with yourself and paint. And not be absolutely miserable. I’m working with a really great non-profit right now. And I’m working in graphic design and I really like that. Seeing friends and…living. It’s really exciting to just have a future of any kind. For so long I would justfeel so ashamed that I wouldn’t get out of bed. And I wouldn’t be in thesunlight and I wouldn’t be on the mountains that I could see out of my window.And just being outside in that stillness. There’s definitely a freedom to it. Had SPRAVATO® been available sooner, I think I could have saved myself a lot of time. I think it’s easy to be embarrassed about mental illness just because of what it is. But once your deep dark secret becomes the thing you’re proudest of, it’s super empowering. I am in a better place now than I have been maybe ever. And I think that’s an amazing gift.
Speaker/SUPER:
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SPRAVATO®?
SPRAVATO® can cause serious side effects, including:
-
Sedation and dissociation. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).
- Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out.
- Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting.
-
Abuse and misuse. There is a risk for abuse and physical and psychological dependence with SPRAVATO® treatment. Your healthcare provider should check you for signs of abuse and dependence before and during treatment with SPRAVATO®.
- Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
- Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
- SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (e.g., medical offices and clinics) must be enrolled in the program.
-
Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.
SPRAVATO® is not for use in children
- Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.
-
How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
- Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
- Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.
-
Tell your healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:
- suicide attempts
- thoughts about suicide or dying
- worsening depression
- other unusual changes in behavior or mood
Do not take SPRAVATO® if you:
- have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs)
- have an abnormal connection between your veins and arteries (arteriovenous malformation)
- have a history of bleeding in the brain
- are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO®.
If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®.
Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you:
-
have heart or brain problems, including:
- high blood pressure (hypertension)
- slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting
- history of heart attack
- history of stroke
- heart valve disease or heart failure
- history of brain injury or any condition where there is increased pressure in the brain
- have liver problems
- have ever had a condition called “psychosis” (see, feel, or hear things that are not there, or believe in things that are not true).
-
are pregnant or plan to become pregnant. SPRAVATO® may harm your baby. You should not take SPRAVATO® if you are pregnant.
- Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO®.
- If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO®.
- There is a pregnancy registry for women who are exposed to SPRAVATO® during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO® and their baby. If you become pregnant during treatment with SPRAVATO®, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
- are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with SPRAVATO®.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO® with certain medicine may cause side effects.
Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How will I take SPRAVATO®?
- You will take SPRAVATO® nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device.
- Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it.
- Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to.
- During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting.
- You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®.
- If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule.
- Some people taking SPRAVATO® get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO® and not drink liquids at least 30 minutes before taking SPRAVATO®.
- If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO®.
What should I avoid while taking SPRAVATO®?
Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See “What is the most important information I should know about SPRAVATO®?”
What are the possible side effects of SPRAVATO®?
SPRAVATO® may cause serious side effects including:
- See “What is the most important information I should know about SPRAVATO®?”
- Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®.
- Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering.
- Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.
The most common side effects of SPRAVATO® when used along with an antidepressant taken by mouth include:
- feeling disconnected from yourself, your thoughts, feelings and things around you
- dizziness
- nausea
- feeling sleepy
- spinning sensation
- decreased feeling of sensitivity (numbness)
- feeling anxious
- lack of energy
- increased blood pressure
- vomiting
- feeling drunk
- feeling very happy or excited
If these common side effects occur, they usually happen right after taking SPRAVATO® and go away the same day.
These are not all the possible side effects of SPRAVATO®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO® at SPRAVATO.com and discuss any questions you may have with your healthcare provider.
SUPER:
cp-79822v3
SUPER:
© Janssen Pharmaceuticals, Inc. 2022. All rights reserved. 06/22 cp-311693v2
“I am in a better place than I have been — maybe ever. I think that’s an amazing gift.”
Grace K.; Colorado Springs, Colorado
Grace, 29,* is a real patient with treatment-resistant depression and has been compensated for her time and testimonial by Janssen Pharmaceuticals, Inc. Individual results may vary.
*Testimonial filmed in 2021.
Click here to watch the next video
View video transcript
Sally: I know that there was a good 15 years where I was barely surviving.
SUPER: SALLY’S STORY
SUPER:
Sally
Age 49 | Virginia
SUPER: Sally is a real patient with treatment-resistant depression and has been compensated for her time by Janssen Pharmaceuticals, Inc.
Sally: When my depression is the worst, it’s hard for me to get motivated.
It makes you feel that you’re not good enough. It makes you feel like you’re the cause, you’re the reason, you’re the blame.
And I was doing what I was told, which was take these medications. Oh, that one’s not working. Well take this one, here add this one, take another one, take another one. And I tried all of that and it didn’t work. My psychiatrist diagnosed me with treatment-resistant depression.
To me, I needed something that was going to come at the depression in a different way. I heard about SPRAVATO® and I thought, well, maybe this is an option for me.
Speaker/SUPER: SPRAVATO® is the first FDA-approved nasal spray, taken along with an oral antidepressant, for adults with treatment-resistant depression.
It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions.
SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®.
SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic) and it is not for use in children.
SPRAVATO® can cause serious side effects including sleepiness, fainting, dizziness, spinning sensation, anxiety or feeling disconnected from yourself, your thoughts, feelings or things around you (dissociation).
Your healthcare provider will monitor you for at least two hours after taking SPRAVATO®.
Please see additional Important Safety Information later in this video.
Sally: Both my psychiatrist and then the treatment center explained to me the different side effects. My thoughts are clearer, you know, whatever that is, noise in my head that’s telling me that I’m not worthy of this, that I’m not smart enough, that I’m not good enough. I didn’t really listen to that chatter anymore.
SUPER: In a clinical study of adults with treatment-resistant depression, those who took SPRAVATO® and an oral antidepressant experienced a greater reduction of depressive symptoms at four weeks compared to those who received a placebo plus an oral antidepressant.
SUPER: Individual results may vary.
Sally: Now, my husband and I love to go see live music. We like to cook. We like to be anywhere near water, really. I have learned that’s part of how I manage my depression, making sure I get outside.
If you’ve tried other things and they’re not working anymore and you feel like there must be something you’re doing wrong, maybe it’s not you. Maybe you just don’t have the right treatment.
The only way the depression doesn’t win is if you keep trying and you speak up for yourself. Because there is help out there. SPRAVATO® has changed how I handle my depression. And how I’m going about my life.
Speaker/SUPER:
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SPRAVATO®?
SPRAVATO® can cause serious side effects, including:
-
Sedation and dissociation. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).
- Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out.
- Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting.
-
Abuse and misuse. There is a risk for abuse and physical and psychological dependence with SPRAVATO® treatment. Your healthcare provider should check you for signs of abuse and dependence before and during treatment with SPRAVATO®.
- Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
- Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
- SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (e.g., medical offices and clinics) must be enrolled in the program.
-
Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.
SPRAVATO® is not for use in children
- Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.
-
How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
- Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
- Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.
-
Tell your healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:
- suicide attempts
- thoughts about suicide or dying
- worsening depression
- other unusual changes in behavior or mood
Do not take SPRAVATO® if you:
- have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs)
- have an abnormal connection between your veins and arteries (arteriovenous malformation)
- have a history of bleeding in the brain
- are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO®.
If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®.
Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you:
-
have heart or brain problems, including:
- high blood pressure (hypertension)
- slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting
- history of heart attack
- history of stroke
- heart valve disease or heart failure
- history of brain injury or any condition where there is increased pressure in the brain
- have liver problems
- have ever had a condition called “psychosis” (see, feel, or hear things that are not there, or believe in things that are not true).
-
are pregnant or plan to become pregnant. SPRAVATO® may harm your baby. You should not take SPRAVATO® if you are pregnant.
- Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO®.
- If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO®.
- There is a pregnancy registry for women who are exposed to SPRAVATO® during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO® and their baby. If you become pregnant during treatment with SPRAVATO®, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
- are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with SPRAVATO®.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO® with certain medicine may cause side effects.
Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How will I take SPRAVATO®?
- You will take SPRAVATO® nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device.
- Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it.
- Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to.
- During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting.
- You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®.
- If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule.
- Some people taking SPRAVATO® get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO® and not drink liquids at least 30 minutes before taking SPRAVATO®.
- If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO®.
What should I avoid while taking SPRAVATO®?
Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See “What is the most important information I should know about SPRAVATO®?”
What are the possible side effects of SPRAVATO®?
SPRAVATO® may cause serious side effects including:
- See “What is the most important information I should know about SPRAVATO®?”
- Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®.
- Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering.
- Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.
The most common side effects of SPRAVATO® when used along with an antidepressant taken by mouth include:
- feeling disconnected from yourself, your thoughts, feelings and things around you
- dizziness
- nausea
- feeling sleepy
- spinning sensation
- decreased feeling of sensitivity (numbness)
- feeling anxious
- lack of energy
- increased blood pressure
- vomiting
- feeling drunk
- feeling very happy or excited
If these common side effects occur, they usually happen right after taking SPRAVATO® and go away the same day.
These are not all the possible side effects of SPRAVATO®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO® at SPRAVATO.com and discuss any questions you may have with your healthcare provider.
SUPER:
cp-79822v3
SUPER:
© Janssen Pharmaceuticals, Inc. 2023. All rights reserved. 07/23 cp-374311v1
“The only way the depression doesn’t win is if you keep trying and you speak up for yourself. Because there is help out there. SPRAVATO® has changed how I handle my depression. And how I’m going about my life.”
Sally R.; Midlothian, Virginia
Sally, 49,* is a real patient with treatment-resistant depression and has been compensated for her time and testimonial by Janssen Pharmaceuticals, Inc. Individual results may vary.
*Testimonial filmed in 2023.
Click here to watch the next video
Nicole’s Story
Ben’s Story
Allison’s
Caregiver Story
Amy’s Story
Grace’s Story
Sally’s Story
View video transcript
Nicole: There were days where I would just break down crying in my bathroom because I just couldn’t do it. I couldn’t get up. I couldn’t take a shower. I couldn’t physically do anything.
SUPER: Nicole’s Story
SUPER:
Nicole
Age 23 | Missouri
SUPER: Nicole, 23, is a real patient with treatment-resistant depression and has been compensated for her time by Janssen Pharmaceuticals, Inc.
Nicole: It was bad. I was kind of cruel towards my mom at times. And there were points where she would just cry because of things I said or things I did. And I didn’t understand that I was being cruel. I didn’t understand that at all. I just lashed out. I ended up going to college. I stayed for about two months. Semester started in August. I dropped out and was home before Halloween. I would sleep 18 to 20 hours a day. I wouldn’t shower for three months. It was crazy. I was getting worse over time. I was having a lot more negative thoughts about myself. And so all these negative thoughts about how I just failed—I failed as a person, I failed myself, I failed my mom, I failed my teachers.
It kind of spirals, to the point where I really hated myself. And I remember thinking, “But I just want to fall asleep and never wake up again.” I walked in to my current psychiatrist with a legitimate page and a half full of medicines that I’d already tried that didn’t work. We found out that I have treatment-resistant depression. At some point, my psychiatrist talked to me about this medical trial study for SPRAVATO®. It really does help with treatment-resistant depression.
SUPER: Individual results may vary.
Speaker/SUPER: SPRAVATO® is the first FDA-approved nasal spray, taken along with an oral antidepressant, for adults with treatment-resistant depression. It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions. SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®. SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic) and it is not for use in children. SPRAVATO® can cause serious side effects including sleepiness, fainting, dizziness, spinning sensation, anxiety or feeling disconnected from yourself, your thoughts, feelings or things around you. Your healthcare provider will monitor you for at least two hours after taking SPRAVATO®. Please see additional Important Safety Information later in this video.
Nicole: Sometimes with depression, not only do you feel it emotionally, it feels like a weight. I was just so light. That was something so new to me.
SUPER: In a clinical study of adults with treatment-resistant depression, those who took SPRAVATO® and an oral antidepressant experienced a greater reduction of depressive symptoms at four weeks compared to those who received a placebo plus an oral antidepressant.
Nicole: When I was truly in my throes of depression, I would start every day off at like a negative six versus a zero. After I started taking SPRAVATO®, I’m starting off the day waking up neutral, which is the best. My mom is my best friend. She is the best. And she has sacrificed her entire life for me and she’s so good. And she is. I’m actually just finishing up my first semester. Eventually, I want to transfer out of my community college. I’m learning so much stuff and I’m growing as a person. So it’s awesome.
I’m 23 now and I’m almost 24, and I never thought I would live to be 24. I just have so many opportunities. It’s awesome.
Speaker/SUPER:
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SPRAVATO®?
SPRAVATO® can cause serious side effects, including:
-
Sedation and dissociation. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).
- Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out.
- Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting.
-
Abuse and misuse. There is a risk for abuse and physical and psychological dependence with SPRAVATO® treatment. Your healthcare provider should check you for signs of abuse and dependence before and during treatment with SPRAVATO®.
- Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
- Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
- SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (e.g., medical offices and clinics) must be enrolled in the program.
-
Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.
SPRAVATO® is not for use in children
- Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.
-
How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
- Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
- Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.
-
Tell your healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:
- suicide attempts
- thoughts about suicide or dying
- worsening depression
- other unusual changes in behavior or mood
Do not take SPRAVATO® if you:
- have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs)
- have an abnormal connection between your veins and arteries (arteriovenous malformation)
- have a history of bleeding in the brain
- are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO®.
If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®.
Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you:
-
have heart or brain problems, including:
- high blood pressure (hypertension)
- slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting
- history of heart attack
- history of stroke
- heart valve disease or heart failure
- history of brain injury or any condition where there is increased pressure in the brain
- have liver problems
- have ever had a condition called “psychosis” (see, feel, or hear things that are not there, or believe in things that are not true).
-
are pregnant or plan to become pregnant. SPRAVATO® may harm your baby. You should not take SPRAVATO® if you are pregnant.
- Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO®.
- If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO®.
- There is a pregnancy registry for women who are exposed to SPRAVATO® during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO® and their baby. If you become pregnant during treatment with SPRAVATO®, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
- are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with SPRAVATO®.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO® with certain medicine may cause side effects.
Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How will I take SPRAVATO®?
- You will take SPRAVATO® nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device.
- Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it.
- Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to.
- During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting.
- You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®.
- If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule.
- Some people taking SPRAVATO® get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO® and not drink liquids at least 30 minutes before taking SPRAVATO®.
- If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO®.
What should I avoid while taking SPRAVATO®?
Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See “What is the most important information I should know about SPRAVATO®?”
What are the possible side effects of SPRAVATO®?
SPRAVATO® may cause serious side effects including:
- See “What is the most important information I should know about SPRAVATO®?”
- Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®.
- Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering.
- Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.
The most common side effects of SPRAVATO® when used along with an antidepressant taken by mouth include:
- feeling disconnected from yourself, your thoughts, feelings and things around you
- dizziness
- nausea
- feeling sleepy
- spinning sensation
- decreased feeling of sensitivity (numbness)
- feeling anxious
- lack of energy
- increased blood pressure
- vomiting
- feeling drunk
- feeling very happy or excited
If these common side effects occur, they usually happen right after taking SPRAVATO® and go away the same day.
These are not all the possible side effects of SPRAVATO®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO® at SPRAVATO.com and discuss any questions you may have with your healthcare provider.
SUPER:
cp-79822v3
SUPER:
© Janssen Pharmaceuticals, Inc. 2021. All rights reserved. 08/21 cp-72100v5
“When I was truly in my throes of depression, I would start every day off at like a negative six versus a zero. After I started taking SPRAVATO®, I’m starting off the day waking up neutral, which is the best.”
Nicole P.; St. Peters, Missouri
Nicole, 23,* is a real patient with treatment-resistant depression and has been compensated for her time and testimonial by Janssen Pharmaceuticals, Inc. Individual results may vary.
*Testimonial filmed in 2018.
View video transcript
Ben: This internal voice wants to convince me that I’m a terrible person, that I don’t know what I’m doing, that nobody likes me, that I’m a literal piece of garbage who doesn’t deserve anything.
SUPER: BEN’S STORY
SUPER:
Ben
Age 40 | New York
SUPER: Ben is a real patient with treatment-resistant depression and has been compensated for his time by Janssen Pharmaceuticals, Inc.
Ben: My depression was picking up more in my thirties. When you’re going through that spiral, you can’t see your hand in front of your face. You’re lost in the mess and it’s just like everything’s wrong. And I wouldn’t be able to function.
Some days I would just collapse in a fit of crying. Probably on only 5 hours of sleep a week, not eating enough. That’s when things were the worst. I tried at least four oral antidepressants.
My psychiatrist told me treatment-resistant depression is something that I had. And there were other options for this. From the research, from what I talk to with my psychiatrist, everything pointed to oral antidepressant, plus the SPRAVATO®. So I was like, yeah, let’s do it.
Speaker/SUPER: SPRAVATO® is the first FDA-approved nasal spray, taken along with an oral antidepressant, for adults with treatment-resistant depression.
It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions.
SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®.
SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic) and it is not for use in children.
SPRAVATO® can cause serious side effects including sleepiness, fainting, dizziness, spinning sensation, anxiety or feeling disconnected from yourself, your thoughts, feelings or things around you (dissociation).
Your healthcare provider will monitor you for at least two hours after taking SPRAVATO®.
Please see additional Important Safety Information later in this video.
Ben: I was learning to love myself each and every session.
SUPER: In a clinical study of adults with treatment-resistant depression, those who took SPRAVATO® and an oral antidepressant experienced a greater reduction of depressive symptoms at four weeks compared to those who received a placebo plus an oral antidepressant.
Ben: I like to have people over. I like to cook. Love to hike and camp. I love running. I run almost daily.
SUPER: Individual results may vary.
Ben: I’m like really proud of where I am now. And I couldn’t have done this without my friends, definitely not without my family, and especially not without SPRAVATO®. It didn’t make me a new person. It helped me become Ben.
Speaker/SUPER:
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SPRAVATO®?
SPRAVATO® can cause serious side effects, including:
-
Sedation and dissociation. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).
- Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out.
- Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting.
-
Abuse and misuse. There is a risk for abuse and physical and psychological dependence with SPRAVATO® treatment. Your healthcare provider should check you for signs of abuse and dependence before and during treatment with SPRAVATO®.
- Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
- Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
- SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (e.g., medical offices and clinics) must be enrolled in the program.
-
Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.
SPRAVATO® is not for use in children
- Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.
-
How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
- Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
- Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.
-
Tell your healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:
- suicide attempts
- thoughts about suicide or dying
- worsening depression
- other unusual changes in behavior or mood
Do not take SPRAVATO® if you:
- have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs)
- have an abnormal connection between your veins and arteries (arteriovenous malformation)
- have a history of bleeding in the brain
- are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO®.
If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®.
Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you:
-
have heart or brain problems, including:
- high blood pressure (hypertension)
- slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting
- history of heart attack
- history of stroke
- heart valve disease or heart failure
- history of brain injury or any condition where there is increased pressure in the brain
- have liver problems
- have ever had a condition called “psychosis” (see, feel, or hear things that are not there, or believe in things that are not true).
-
are pregnant or plan to become pregnant. SPRAVATO® may harm your baby. You should not take SPRAVATO® if you are pregnant.
- Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO®.
- If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO®.
- There is a pregnancy registry for women who are exposed to SPRAVATO® during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO® and their baby. If you become pregnant during treatment with SPRAVATO®, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
- are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with SPRAVATO®.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO® with certain medicine may cause side effects.
Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How will I take SPRAVATO®?
- You will take SPRAVATO® nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device.
- Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it.
- Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to.
- During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting.
- You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®.
- If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule.
- Some people taking SPRAVATO® get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO® and not drink liquids at least 30 minutes before taking SPRAVATO®.
- If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO®.
What should I avoid while taking SPRAVATO®?
Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See “What is the most important information I should know about SPRAVATO®?”
What are the possible side effects of SPRAVATO®?
SPRAVATO® may cause serious side effects including:
- See “What is the most important information I should know about SPRAVATO®?”
- Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®.
- Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering.
- Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.
The most common side effects of SPRAVATO® when used along with an antidepressant taken by mouth include:
- feeling disconnected from yourself, your thoughts, feelings and things around you
- dizziness
- nausea
- feeling sleepy
- spinning sensation
- decreased feeling of sensitivity (numbness)
- feeling anxious
- lack of energy
- increased blood pressure
- vomiting
- feeling drunk
- feeling very happy or excited
If these common side effects occur, they usually happen right after taking SPRAVATO® and go away the same day.
These are not all the possible side effects of SPRAVATO®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO® at SPRAVATO.com and discuss any questions you may have with your healthcare provider.
SUPER:
cp-79822v3
SUPER:
© Janssen Pharmaceuticals, Inc. 2023. All rights reserved. 07/23 cp-374310v1
“I’m really proud of where I am now. And I couldn’t have done this without SPRAVATO®. It didn’t make me a new person. It helped me become Ben.”
Ben L.; Brooklyn, New York
Ben, 40,* is a real patient with treatment-resistant depression and has been compensated for his time and testimonial by Janssen Pharmaceuticals, Inc. Individual results may vary.
*Testimonial filmed in 2023.
View video transcript
Allison: All of my effort, all of my attention went to him and finding the right treatment. To have tried everything and to know he’s not getting better, that was very difficult.
SUPER:
A Caregiver’s Story
About Treatment-Resistant Depression
SUPER:
Allison
Pikeville, Kentucky
SUPER: Allison is a real caregiver for her adult son with treatment-resistant depression and is an employee of Janssen Pharmaceutical Companies of Johnson & Johnson.
Allison: He was just a very sensitive child. My son would not ever want a balloon because he knew it wouldn’t last. So if he lost it, he would start immediately crying. And high school, that’s when we really started seeing the depression. He started sleeping more, wrecking his room, not wanting to go to school. I actually had a truancy officer come and visit me. So you’re talking about a straight-A student that got a scholarship from the University of Kentucky that was now in danger of failing his senior year. So we got with this psychologist and talked to her and she recommended that he might need to start on some sort of medication.
He tried around seven or eight and different combinations of oral medications, after like two, three months, they would just fail. Nothing seemed to work. He was getting ready to move away to go to school, and I was going to have to say goodbye to him and watch him leave the nest when I knew he was really not well. I was a worried mama. I spent a lot of time on the road going back and forth to make sure he was okay. I would go and check on him and, you know, his room would be a mess, and he would be a mess, and he would be sleeping all the time. When a person has treatment-resistant depression, they really aren’t taking care of themselves. And it’s not that they don’t want to, it’s just they’re in this cycle and they don’t know how to get out of it. I spent a lot of time on the phone, you know, talking to a psychologist, talking to the psychiatrist about what we were going to do next because he wasn’t getting any better. In fact, he was getting worse.
I had four other kids at home, and I wasn’t able to give them the attention, love, whatever they needed, which hurts me because, you know, I do love my children very much. So, a lot of those drives were spent in tears. You feel hopeless and helpless. It’s your baby. No matter how old they are, that’s still your baby. After he had been in school for a little while, I got the call that every mother dreads: he had tried to commit suicide. And, you know, it’s one of those things that—it’s surreal, you just can’t imagine your life without your child. But treatment-resistant depression is a disease, just like diabetes or anything else. I mean, you just have to keep going, because it’s your child’s life. Luckily SPRAVATO® came out when it did.
Speaker/SUPER: SPRAVATO® is the first FDA-approved nasal spray, taken along with an oral antidepressant, for adults with treatment-resistant depression. It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions. SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®. SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic) and it is not for use in children. SPRAVATO® can cause serious side effects including sleepiness, fainting, dizziness, spinning sensation, anxiety or feeling disconnected from yourself, your thoughts, feelings or things around you. Your healthcare provider will monitor you for at least two hours after taking SPRAVATO®. Please see additional Important Safety Information later in this video.
Allison: So, after a few weeks, his symptoms started to improve and his hygiene got better. He started calling me on the phone more, he became interested in gardening and cooking.
SUPER: In a clinical study of adults with treatment-resistant depression, those who took SPRAVATO® and an oral antidepressant experienced a greater reduction of depressive symptoms at four weeks compared to those who received a placebo plus an oral antidepressant.
Individual results may vary.
Allison: He composts, he has pumpkins, he has spinach, he has blueberries. Anytime that he gets off from work, he’s out working in his garden. In addition to the SPRAVATO®, he’s taken an oral antidepressant. My son is 22 now. He’s doing so much better. He’s working in a restaurant. He aspires to go to chef school soon. And I was able to get my mind off of just him. I’m there for my kids more; I’m there for my husband.
The misconception is you should be able to pull yourself up by the bootstraps and just be able to get yourself out of it, and that’s simply not true. You have to have a team and you have to have the right medications to carry on. When somebody has treatment-resistant depression, it’s easy for them to lose hope, so you have to be that hope for them. I think the future is very bright for my son. I think he’s going to be a renowned chef. I mean, that’s my hopes for him, but most of all, I want him to be happy. There is hope out there. I’ve gotten my son back.
Speaker/SUPER:
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SPRAVATO®?
SPRAVATO® can cause serious side effects, including:
-
Sedation and dissociation. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).
- Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out.
- Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting.
-
Abuse and misuse. There is a risk for abuse and physical and psychological dependence with SPRAVATO® treatment. Your healthcare provider should check you for signs of abuse and dependence before and during treatment with SPRAVATO®.
- Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
- Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
- SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (e.g., medical offices and clinics) must be enrolled in the program.
-
Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger,especially within the first few months of treatment or when the dose is changed.
SPRAVATO® is not for use in children
- Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.
-
How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
- Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
- Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.
-
Tell your healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:
- suicide attempts
- thoughts about suicide or dying
- worsening depression
- other unusual changes in behavior or mood
Do not take SPRAVATO® if you:
- have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs)
- have an abnormal connection between your veins and arteries (arteriovenous malformation)
- have a history of bleeding in the brain
- are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO®.
If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®.
Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you:
-
have heart or brain problems, including:
- high blood pressure (hypertension)
- slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting
- history of heart attack
- history of stroke
- heart valve disease or heart failure
- history of brain injury or any condition where there is increased pressure in the brain
- have liver problems
- have ever had a condition called “psychosis” (see, feel, or hear things that are not there, or believe in things that are not true).
-
are pregnant or plan to become pregnant. SPRAVATO® may harm your baby. You should not take SPRAVATO® if you are pregnant.
- Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO®.
- If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO®.
- There is a pregnancy registry for women who are exposed to SPRAVATO® during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO® and their baby. If you become pregnant during treatment with SPRAVATO®, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
- are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with SPRAVATO®.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO® with certain medicine may cause side effects.
Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How will I take SPRAVATO®?
- You will take SPRAVATO® nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device.
- Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it.
- Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to.
- During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting.
- You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®.
- If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule.
- Some people taking SPRAVATO® get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO® and not drink liquids at least 30 minutes before taking SPRAVATO®.
- If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO®.
What should I avoid while taking SPRAVATO®?
Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See “What is the most important information I should know about SPRAVATO®?”
What are the possible side effects of SPRAVATO®?
SPRAVATO® may cause serious side effects including:
- See “What is the most important information I should know about SPRAVATO®?”
- Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®.
- Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering.
- Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.
The most common side effects of SPRAVATO® when used along with an antidepressant taken by mouth include:
- feeling disconnected from yourself, your thoughts, feelings and things around you
- dizziness
- nausea
- feeling sleepy
- spinning sensation
- decreased feeling of sensitivity (numbness)
- feeling anxious
- lack of energy
- increased blood pressure
- vomiting
- feeling drunk
- feeling very happy or excited
If these common side effects occur, they usually happen right after taking SPRAVATO® and go away the same day.
These are not all the possible side effects of SPRAVATO®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO® at SPRAVATO.com and discuss any questions you may have with your healthcare provider.
SUPER:
cp-79822v3
SUPER:
© Janssen Pharmaceuticals, Inc. 2021. All rights reserved. 09/21 cp-191060v2
“My son is 22* now. He’s doing so much better.”
Allison F.; Pikeville, Kentucky
Caregiver for son with treatment-resistant depression
Allison is a real caregiver for her adult son with treatment-resistant depression. She is an employee of Janssen Pharmaceutical Companies of Johnson & Johnson. Individual results may vary.
*Testimonial filmed in 2021.
View video transcript
Amelia: I felt like the depression just robbed me of, of everything.
I mean, it almost robbed me of my life.
SUPER:
AMELIA’S STORY
SUPER:
Amelia
Age 52 | Minnesota
SUPER: Amelia is a real patient with treatment-resistant depression and has been compensated for her time by Janssen Pharmaceuticals, Inc.
Amelia: It’s like these monsters were in the basement of my house, banging at the door to try to get into the rest of the house and to me and, like, destroy me. So I always felt like I was trying to suppress that depression.
I couldn’t do things that I normally would have liked to do, like art and writing. I tried multiple oral antidepressants and those weren’t working. So for my doctor to say, you have treatment-resistant depression, it wasn’t really a surprise. I really, I did think about taking my life and how, how it would be so much better to feel nothing.
SUPER: There are no approved therapeutic options for prevention of suicide or reduction of suicidal thoughts or actions.
Amelia: My doctor started talking about these new ways to help people with treatment-resistant depression like SPRAVATO®. I was, I was hopeful about this.
Speaker/SUPER: SPRAVATO® is the first FDA-approved nasal spray, taken along with an oral antidepressant, for adults with treatment-resistant depression.
It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions.
SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®.
SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic) and it is not for use in children.
SPRAVATO® can cause serious side effects including sleepiness, fainting, dizziness, spinning sensation, anxiety or feeling disconnected from yourself, your thoughts, feelings or things around you (dissociation).
Your healthcare provider will monitor you for at least two hours after taking SPRAVATO®.
Please see additional Important Safety Information later in this video.
SUPER: In a clinical study of adults with treatment-resistant depression, those who took SPRAVATO® and an oral antidepressant experienced a greater reduction of depressive symptoms at four weeks compared to those who received a placebo plus an oral antidepressant.
Individual results may vary.
Amelia: I felt like I was waking up from depression, like I had been trapped in one part of my mind for a long time and now I’m going outside, I’m talking to the neighbors, I’m walking my dog. I had access to myself, my creativity. It’s like I could see the world around me, like how beautiful the people in my life were.
SUPER: If you’re experiencing suicidal thoughts, call your healthcare provider right away or call the National Suicide Prevention Lifeline at 1-800-273-8255.
Amelia: I really want people to know that even if oral antidepressants didn’t work for them, they should not give up. If I could have had SPRAVATO® years ago, that would have been wonderful. I’m living life definitely to its fullest now.
Speaker/SUPER:
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SPRAVATO®?
SPRAVATO® can cause serious side effects, including:
-
Sedation and dissociation. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).
- Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out.
- Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting.
-
Abuse and misuse. There is a risk for abuse and physical and psychological dependence with SPRAVATO® treatment. Your healthcare provider should check you for signs of abuse and dependence before and during treatment with SPRAVATO®.
- Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
- Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
- SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (e.g., medical offices and clinics) must be enrolled in the program.
-
Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.
SPRAVATO® is not for use in children
- Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.
-
How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
- Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
- Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.
-
Tell your healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:
- suicide attempts
- thoughts about suicide or dying
- worsening depression
- other unusual changes in behavior or mood
Do not take SPRAVATO® if you:
- have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs)
- have an abnormal connection between your veins and arteries (arteriovenous malformation)
- have a history of bleeding in the brain
- are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO®.
If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®.
Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you:
-
have heart or brain problems, including:
- high blood pressure (hypertension)
- slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting
- history of heart attack
- history of stroke
- heart valve disease or heart failure
- history of brain injury or any condition where there is increased pressure in the brain
- have liver problems
- have ever had a condition called “psychosis” (see, feel, or hear things that are not there, or believe in things that are not true).
-
are pregnant or plan to become pregnant. SPRAVATO® may harm your baby. You should not take SPRAVATO® if you are pregnant.
- Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO®.
- If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO®.
- There is a pregnancy registry for women who are exposed to SPRAVATO® during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO® and their baby. If you become pregnant during treatment with SPRAVATO®, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
- are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with SPRAVATO®.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO® with certain medicine may cause side effects.
Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How will I take SPRAVATO®?
- You will take SPRAVATO® nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device.
- Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it.
- Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to.
- During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting.
- You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®.
- If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule.
- Some people taking SPRAVATO® get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO® and not drink liquids at least 30 minutes before taking SPRAVATO®.
- If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO®.
What should I avoid while taking SPRAVATO®?
Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See “What is the most important information I should know about SPRAVATO®?”
What are the possible side effects of SPRAVATO®?
SPRAVATO® may cause serious side effects including:
- See “What is the most important information I should know about SPRAVATO®?”
- Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®.
- Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering.
- Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.
The most common side effects of SPRAVATO® when used along with an antidepressant taken by mouth include:
- feeling disconnected from yourself, your thoughts, feelings and things around you
- dizziness
- nausea
- feeling sleepy
- spinning sensation
- decreased feeling of sensitivity (numbness)
- feeling anxious
- lack of energy
- increased blood pressure
- vomiting
- feeling drunk
- feeling very happy or excited
If these common side effects occur, they usually happen right after taking SPRAVATO® and go away the same day.
These are not all the possible side effects of SPRAVATO®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO® at SPRAVATO.com and discuss any questions you may have with your healthcare provider.
SUPER:
cp-79822v3
SUPER:
© Janssen Pharmaceuticals, Inc. 2023. All rights reserved. 07/23 cp-374309v1
“I really want people to know that even if oral antidepressants didn’t work for them, they should not give up.”
Amelia M.; Edina, Minnesota
Amelia, 52,* is a real patient with treatment-resistant depression and has been compensated for her time and testimonial by Janssen Pharmaceuticals, Inc. Individual results may vary.
*Testimonial filmed in 2023.
View video transcript
Grace: I remember sitting down in the shower one time and just bawling my eyes out until the water went cold. And then, even after the water went cold, I just sat there, bawling.
SUPER: GRACE’S STORY
Grace: College was incredibly difficult for me. Everything becomes such a colossal challenge with depression
SUPER:
Grace
Age 29 | Colorado
SUPER: Grace is a real patient with treatment-resistant depression and has been compensated for her time by Janssen Pharmaceuticals, Inc.
Grace: I would sit there in class and just feel so uncomfortable and... I felt like I was crawling out of my skin at every second. I was absolutely miserable and I was too afraid to tell anyone because how can you be miserable in college? It’s supposed to be the best. I just could not understand why I wasn’t having the same experience that everyone else was. I don’t know if I was really even aware of how unhappy I truly was. Because I was just focused on pretending. My smile was fake, and my laughing was fake, and all of those pictures were fake. And pretending to be happy when you’re not just takes the life out of you.
Grace: Depression doesn’t steal everything in one fell swoop; it, it takes things little by little. At first, I wouldn’t want to go out one night, and then I wouldn’t want to go out at all. I wouldn’t feel like going to the gym that one day, and then I just wouldn’t go ever. And I was trying all different kinds of medications. I think, at this point, I’m at 16 different antidepressants that I’ve tried. It even got to the point that I tried electric convulsive therapy. The worst part about that was that it didn’t work. That was one new low for me... and after that, I was truly and utterly lost. I just remember... sitting there, talking to my mom and just telling her that I was going to be this unhappy forever and that seemed like an insurmountable obstacle to tackle.
SUPER: If you’re experiencing suicidal thoughts, call your healthcare provider right away or call the National Suicide Prevention Lifeline at 1-800-273-8255
Grace: Hope is something incredibly difficult to maintain when you have depression. Hope can be poison. You start a new medication and you feel hopeful ... and then ... it doesn’t work and your heart’s broken. And 16 medications and 16 heartbreaks later ... it seems ludicrous to put yourself in that position again. But what is your other option? You know, either you keep trying or you live in the hell that you’re in for the rest of your life.
Grace: I read about a medication called SPRAVATO® and the more that I read, the more reluctantly hopeful I became.
Speaker/SUPER: SPRAVATO® is the first FDA-approved nasal spray, taken along with an oral antidepressant, for adults with treatment-resistant depression. It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions. SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®. SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic) and it is not for use in children. SPRAVATO® can cause serious side effects including sleepiness, fainting, dizziness, spinning sensation, anxiety or feeling disconnected from yourself, your thoughts, feelings or things around you (dissociation). Your healthcare provider will monitor you for at least two hours after taking SPRAVATO®. Please see additional Important Safety Information later in this video.
Grace: So I didn’t notice right away but my family did. My mom would say that she would see me smiling more. Or my boyfriend would say that he had heard me laugh for the first time in far too long.
SUPER: In a clinical study of adults with treatment-resistant depression, those who took SPRAVATO® and an oral antidepressant experienced a greater reduction of depressive symptoms at four weeks compared to those who received a placebo plus an oral antidepressant.
SUPER: Individual results may vary.
Grace: And then I slowly started to realize it. It’s so cliché to say this, but it’s really like a veil had lifted. I started realizing that I was getting better when I wanted to do things—I wasn’t forcing myself to do them.
Grace: The most amazing feeling to be able to just, just sit with yourself and paint. And not be absolutely miserable. I’m working with a really great non-profit right now. And I’m working in graphic design and I really like that. Seeing friends and…living. It’s really exciting to just have a future of any kind. For so long I would justfeel so ashamed that I wouldn’t get out of bed. And I wouldn’t be in thesunlight and I wouldn’t be on the mountains that I could see out of my window.And just being outside in that stillness. There’s definitely a freedom to it. Had SPRAVATO® been available sooner, I think I could have saved myself a lot of time. I think it’s easy to be embarrassed about mental illness just because of what it is. But once your deep dark secret becomes the thing you’re proudest of, it’s super empowering. I am in a better place now than I have been maybe ever. And I think that’s an amazing gift.
Speaker/SUPER:
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SPRAVATO®?
SPRAVATO® can cause serious side effects, including:
-
Sedation and dissociation. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).
- Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out.
- Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting.
-
Abuse and misuse. There is a risk for abuse and physical and psychological dependence with SPRAVATO® treatment. Your healthcare provider should check you for signs of abuse and dependence before and during treatment with SPRAVATO®.
- Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
- Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
- SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (e.g., medical offices and clinics) must be enrolled in the program.
-
Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.
SPRAVATO® is not for use in children
- Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.
-
How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
- Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
- Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.
-
Tell your healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:
- suicide attempts
- thoughts about suicide or dying
- worsening depression
- other unusual changes in behavior or mood
Do not take SPRAVATO® if you:
- have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs)
- have an abnormal connection between your veins and arteries (arteriovenous malformation)
- have a history of bleeding in the brain
- are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO®.
If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®.
Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you:
-
have heart or brain problems, including:
- high blood pressure (hypertension)
- slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting
- history of heart attack
- history of stroke
- heart valve disease or heart failure
- history of brain injury or any condition where there is increased pressure in the brain
- have liver problems
- have ever had a condition called “psychosis” (see, feel, or hear things that are not there, or believe in things that are not true).
-
are pregnant or plan to become pregnant. SPRAVATO® may harm your baby. You should not take SPRAVATO® if you are pregnant.
- Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO®.
- If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO®.
- There is a pregnancy registry for women who are exposed to SPRAVATO® during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO® and their baby. If you become pregnant during treatment with SPRAVATO®, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
- are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with SPRAVATO®.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO® with certain medicine may cause side effects.
Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How will I take SPRAVATO®?
- You will take SPRAVATO® nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device.
- Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it.
- Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to.
- During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting.
- You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®.
- If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule.
- Some people taking SPRAVATO® get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO® and not drink liquids at least 30 minutes before taking SPRAVATO®.
- If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO®.
What should I avoid while taking SPRAVATO®?
Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See “What is the most important information I should know about SPRAVATO®?”
What are the possible side effects of SPRAVATO®?
SPRAVATO® may cause serious side effects including:
- See “What is the most important information I should know about SPRAVATO®?”
- Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®.
- Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering.
- Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.
The most common side effects of SPRAVATO® when used along with an antidepressant taken by mouth include:
- feeling disconnected from yourself, your thoughts, feelings and things around you
- dizziness
- nausea
- feeling sleepy
- spinning sensation
- decreased feeling of sensitivity (numbness)
- feeling anxious
- lack of energy
- increased blood pressure
- vomiting
- feeling drunk
- feeling very happy or excited
If these common side effects occur, they usually happen right after taking SPRAVATO® and go away the same day.
These are not all the possible side effects of SPRAVATO®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO® at SPRAVATO.com and discuss any questions you may have with your healthcare provider.
SUPER:
cp-79822v3
SUPER:
© Janssen Pharmaceuticals, Inc. 2022. All rights reserved. 06/22 cp-311693v2
“I am in a better place than I have been — maybe ever. I think that’s an amazing gift.”
Grace K.; Colorado Springs, Colorado
Grace, 29,* is a real patient with treatment-resistant depression and has been compensated for her time and testimonial by Janssen Pharmaceuticals, Inc. Individual results may vary.
*Testimonial filmed in 2021.
View video transcript
Sally: I know that there was a good 15 years where I was barely surviving.
SUPER: SALLY’S STORY
SUPER:
Sally
Age 49 | Virginia
SUPER: Sally is a real patient with treatment-resistant depression and has been compensated for her time by Janssen Pharmaceuticals, Inc.
Sally: When my depression is the worst, it’s hard for me to get motivated.
It makes you feel that you’re not good enough. It makes you feel like you’re the cause, you’re the reason, you’re the blame.
And I was doing what I was told, which was take these medications. Oh, that one’s not working. Well take this one, here add this one, take another one, take another one. And I tried all of that and it didn’t work. My psychiatrist diagnosed me with treatment-resistant depression.
To me, I needed something that was going to come at the depression in a different way. I heard about SPRAVATO® and I thought, well, maybe this is an option for me.
Speaker/SUPER: SPRAVATO® is the first FDA-approved nasal spray, taken along with an oral antidepressant, for adults with treatment-resistant depression.
It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions.
SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®.
SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic) and it is not for use in children.
SPRAVATO® can cause serious side effects including sleepiness, fainting, dizziness, spinning sensation, anxiety or feeling disconnected from yourself, your thoughts, feelings or things around you (dissociation).
Your healthcare provider will monitor you for at least two hours after taking SPRAVATO®.
Please see additional Important Safety Information later in this video.
Sally: Both my psychiatrist and then the treatment center explained to me the different side effects. My thoughts are clearer, you know, whatever that is, noise in my head that’s telling me that I’m not worthy of this, that I’m not smart enough, that I’m not good enough. I didn’t really listen to that chatter anymore.
SUPER: In a clinical study of adults with treatment-resistant depression, those who took SPRAVATO® and an oral antidepressant experienced a greater reduction of depressive symptoms at four weeks compared to those who received a placebo plus an oral antidepressant.
SUPER: Individual results may vary.
Sally: Now, my husband and I love to go see live music. We like to cook. We like to be anywhere near water, really. I have learned that’s part of how I manage my depression, making sure I get outside.
If you’ve tried other things and they’re not working anymore and you feel like there must be something you’re doing wrong, maybe it’s not you. Maybe you just don’t have the right treatment.
The only way the depression doesn’t win is if you keep trying and you speak up for yourself. Because there is help out there. SPRAVATO® has changed how I handle my depression. And how I’m going about my life.
Speaker/SUPER:
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SPRAVATO®?
SPRAVATO® can cause serious side effects, including:
-
Sedation and dissociation. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).
- Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out.
- Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting.
-
Abuse and misuse. There is a risk for abuse and physical and psychological dependence with SPRAVATO® treatment. Your healthcare provider should check you for signs of abuse and dependence before and during treatment with SPRAVATO®.
- Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
- Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
- SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (e.g., medical offices and clinics) must be enrolled in the program.
-
Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.
SPRAVATO® is not for use in children
- Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.
-
How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
- Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
- Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.
-
Tell your healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:
- suicide attempts
- thoughts about suicide or dying
- worsening depression
- other unusual changes in behavior or mood
Do not take SPRAVATO® if you:
- have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs)
- have an abnormal connection between your veins and arteries (arteriovenous malformation)
- have a history of bleeding in the brain
- are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO®.
If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®.
Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you:
-
have heart or brain problems, including:
- high blood pressure (hypertension)
- slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting
- history of heart attack
- history of stroke
- heart valve disease or heart failure
- history of brain injury or any condition where there is increased pressure in the brain
- have liver problems
- have ever had a condition called “psychosis” (see, feel, or hear things that are not there, or believe in things that are not true).
-
are pregnant or plan to become pregnant. SPRAVATO® may harm your baby. You should not take SPRAVATO® if you are pregnant.
- Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO®.
- If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO®.
- There is a pregnancy registry for women who are exposed to SPRAVATO® during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO® and their baby. If you become pregnant during treatment with SPRAVATO®, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
- are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with SPRAVATO®.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO® with certain medicine may cause side effects.
Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How will I take SPRAVATO®?
- You will take SPRAVATO® nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device.
- Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it.
- Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to.
- During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting.
- You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®.
- If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule.
- Some people taking SPRAVATO® get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO® and not drink liquids at least 30 minutes before taking SPRAVATO®.
- If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO®.
What should I avoid while taking SPRAVATO®?
Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See “What is the most important information I should know about SPRAVATO®?”
What are the possible side effects of SPRAVATO®?
SPRAVATO® may cause serious side effects including:
- See “What is the most important information I should know about SPRAVATO®?”
- Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®.
- Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering.
- Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.
The most common side effects of SPRAVATO® when used along with an antidepressant taken by mouth include:
- feeling disconnected from yourself, your thoughts, feelings and things around you
- dizziness
- nausea
- feeling sleepy
- spinning sensation
- decreased feeling of sensitivity (numbness)
- feeling anxious
- lack of energy
- increased blood pressure
- vomiting
- feeling drunk
- feeling very happy or excited
If these common side effects occur, they usually happen right after taking SPRAVATO® and go away the same day.
These are not all the possible side effects of SPRAVATO®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO® at SPRAVATO.com and discuss any questions you may have with your healthcare provider.
SUPER:
cp-79822v3
SUPER:
© Janssen Pharmaceuticals, Inc. 2023. All rights reserved. 07/23 cp-374311v1
“The only way the depression doesn’t win is if you keep trying and you speak up for yourself. Because there is help out there. SPRAVATO® has changed how I handle my depression. And how I’m going about my life.”
Sally R.; Midlothian, Virginia
Sally, 49,* is a real patient with treatment-resistant depression and has been compensated for her time and testimonial by Janssen Pharmaceuticals, Inc. Individual results may vary.
*Testimonial filmed in 2023.
Your Story Matters, Share It
Has SPRAVATO® made a difference with your treatment-resistant depression?
Share your story with the SHARE Network.
Your Story Matters, Share It
Has SPRAVATO® made a difference with your treatment-resistant depression? Share your story with the SHARE Network.
MDSI: Depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions.
What is MDSI?