Preparing for Treatment

Preparing for Treatment What to know if you’re considering SPRAVATO®

What to Expect During Your 
SPRAVATO® Treatment

Watch this video to learn about the SPRAVATO® 
treatment process.

Speaker: Welcome to an overview of SPRAVATO® (esketamine) nasal spray CIII.

Speaker/SUPER: SPRAVATO® is a prescription medicine, taken along with an oral antidepressant, for treatment-resistant depression in adults. SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO® is safe and effective as an anesthetic medicine. 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®. It is not known if SPRAVATO® is safe and effective in children.

Speaker: You may want to talk to your healthcare provider about SPRAVATO® if you’ve been struggling with depression and are ready to discuss a different option that may work for you. Before prescribing SPRAVATO®, your healthcare provider will review your medical history, discuss safety information, and answer your questions.

SUPER: You may want to talk to your healthcare provider about SPRAVATO® if you’ve been struggling with depression, have tried two or more antidepressants in the current episode without adequate relief, and are ready to discuss a different option that may work for you. SPRAVATO® is not for everyone. Please read the Medication Guide on SPRAVATO.com and be sure to tell your healthcare provider about your complete medical history.

Speaker: SPRAVATO® can cause serious side effects, including sedation and dissociation. There is a risk for abuse with SPRAVATO®. Be sure to tell your healthcare provider if you have a history of abusing prescription or street drugs or a problem with alcohol. Because of these risks, SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) program. There is an increased risk of suicidal thoughts and behavior with SPRAVATO®. Call your healthcare provider right away if you have new or sudden changes in mood, behavior, thoughts or feelings. If you and your healthcare provider decide that SPRAVATO® could be part of your overall treatment plan, here’s an overview of what to expect.

SUPER:

IMPORTANT SAFETY INFORMATION:

SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings and things around you (dissociation). There is a risk for abuse and physical and psychological dependence with SPRAVATO® treatment. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® may cause worsening of depression and suicidal thoughts and behaviors. Call your healthcare provider right away if you have new or sudden changes in mood, behavior, thoughts or feelings, or if you develop suicidal thoughts or actions. Please see the Important Safety Information at the end of this video, and full Prescribing Information, including Boxed WARNINGS, on SPRAVATO.com.

Speaker: SPRAVATO® is given at certified SPRAVATO® treatment centers, and you and your healthcare provider can choose a location. Your first visit to the certified SPRAVATO® treatment center will be a consultation.

SUPER: First, a consultation

Speaker: A healthcare provider will discuss your medical history, schedule appointments, check your insurance, and map out your SPRAVATO® treatment plan. At outpatient settings, your healthcare provider will enroll you in the SPRAVATO® REMS to keep track of serious side effects you may experience, including sedation or dissociation.

SUPER: SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS and to patients enrolled in the program.

Speaker: Then on your next visit, you can start treatment with SPRAVATO®. You’ll learn more about administration on the day of your treatment.

SUPER: What to expect on treatment days

Speaker: On treatment days, you’ll take SPRAVATO® nasal spray yourself under the supervision of a healthcare provider.

SUPER: Observation period

Speaker: After administering your dose, you may want to listen to music, read or just relax while a healthcare provider monitors you for at least two hours to check for possible side effects, like increased blood pressure.

SUPER: SPRAVATO® can cause a temporary increase in your blood pressure that may last for about four hours – so you will have your blood pressure measured before administration and periodically for at least two hours.

Speaker: Other serious side effects include problems with thinking clearly and bladder problems. See the most common side effects on screen below.

SUPER:

Most common side effects include:

  • dissociation
  • dizziness
  • nausea
  • sedation
  • spinning sensation
  • decreased feeling of sensitivity (numbness)
  • feeling anxious
  • lack of energy
  • increased blood pressure
  • vomiting
  • feeling drunk
  • feeling very happy or excited

Tell your healthcare provider if you experience any side effects while taking SPRAVATO®. These common side effects usually happen right after taking SPRAVATO® and go away the same day.

Speaker: After the observation period when your healthcare provider gives you the okay, you’ll be ready to leave.

SUPER: Please see the Important Safety Information in this video, and full Prescribing Information, including Boxed WARNINGS, on SPRAVATO.com.

Speaker: Keep in mind, you won’t be able to drive or operate machinery until the next day after a restful sleep, so you’ll need to plan for rides on treatment days.

SUPER: SPRAVATO® treatment plan for treatment-resistant depression

Speaker: You’ll take SPRAVATO® twice a week for the first month. During the second month, you’ll take SPRAVATO® once a week. After that, SPRAVATO® is usually taken once a week or once every two weeks.

SUPER: Continue taking your oral antidepressants as prescribed.

SUPER: Share your progress

Speaker: Be sure to share your progress with your healthcare provider, who will remain an important part of your care. Are you ready to talk to your doctor about SPRAVATO®? Discuss the facts and decide together if SPRAVATO® could be part of your overall treatment plan. Please listen to the following Important Safety Information in this video.

SUPER: Please listen to the following Important Safety Information in this video and read the Prescribing Information, including Boxed WARNINGS, and Medication Guide available on SPRAVATO.com.

Speaker/SUPER:

What is SPRAVATO® (esketamine) CIII nasal spray?

SPRAVATO® is a prescription medicine, used along with an antidepressant taken by mouth to treat:

  • Adults with treatment-resistant depression (TRD)
  • Depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions.

SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO® is safe or effective as an anesthetic medicine.

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®.

It is not known if SPRAVATO® is safe and effective in children.

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. 2020. All rights reserved. 9/20 cp-63556v3

I am ready to see what starting treatment will be like.

 

Getting Started with SPRAVATO®

Working with Your Healthcare Provider

Considering SPRAVATO®? The first step is talking to your healthcare provider. Get the facts and decide together if SPRAVATO® should be part of your overall treatment plan for your treatment-resistant depression.

Expect to review your overall medical and depression treatment history in deciding with your healthcare provider whether SPRAVATO® is right for you.

  • Be sure to tell your healthcare provider if you have a history of abusing prescription or street drugs, or a problem with alcohol
  • Do not take SPRAVATO® if you have a blood vessel disease (aneurysm), an abnormal connection between your blood vessels (arteriovenous malformation), a history of bleeding in the brain or if you are allergic to esketamine, ketamine or any of the ingredients in SPRAVATO®
  • Be sure to tell your healthcare provider if you have heart, brain or liver problems; if you have psychosis; or if you are pregnant, planning to become pregnant, breastfeeding or planning to breastfeed. You should not take SPRAVATO® if you are pregnant. You should not breastfeed if you are taking SPRAVATO®
  • Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements
  • Ask if adding SPRAVATO® to your overall treatment plan might be a next step for you
  • For more complete information, please see the Medication Guide

Planning Your Treatment with SPRAVATO®

SPRAVATO® can only be administered under the supervision of a healthcare provider at a certified SPRAVATO® treatment center. This could be a different location than your regular doctor’s office. Your healthcare provider will continue to be involved with your care during SPRAVATO® treatment and will be available to answer questions or address concerns as you undergo treatment.

If you are a new patient at the certified SPRAVATO® treatment center, your first visit will be a consultation. The treatment center will:

  • receive your medical information from your healthcare provider
  • conduct its own assessment to determine if SPRAVATO® may be right for you
  • verify your insurance information as part of the eligibility confirmation

If SPRAVATO® is recommended, the treatment center will build a treatment plan with you and enroll you in the SPRAVATO® REMS Program. You may start treatment on your next visit.

 

Treatment Days

Preparing for Treatment

You may start treatment as soon as your second visit to the SPRAVATO® treatment center.

Plan for rides to and from the treatment center. You won’t be able to drive, operate machinery or do anything where you need to be completely alert until the day after a treatment session, following a restful sleep.

Bring a form of entertainment, like a book or playlist, for the session. A healthcare provider at the treatment center will monitor you for at least two hours after treatment.

Avoid eating two hours before, and drinking liquids 30 minutes before, the treatment session. Some patients taking SPRAVATO® may experience nausea or vomiting.

If you take a nasal corticosteroid or nasal decongestant medicine, take these medicines at least one hour before taking SPRAVATO®.

  • At each session, you will be asked about your current depressive symptoms and how you are feeling over time
  • After you administer SPRAVATO®, there will be an observation period of at least two hours, during which you will be allowed to rest comfortably while a healthcare provider monitors you for possible side effects
  • SPRAVATO® can cause a temporary increase in your blood pressure that may last for about four hours after taking a dose. Your healthcare provider will check your blood pressure before you take SPRAVATO® and for at least two 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®
  • Tell your healthcare provider if you have problems thinking or remembering
  • Tell your healthcare provider if you have any side effect that bothers you or does not go away
  • Before you leave, talk to your healthcare provider about your plans for the remainder of the day to figure out which activities may or may not be appropriate
  • Be sure you have accurate contact information for the certified SPRAVATO® treatment center in case any questions or concerns come up after you leave
  • Be sure to share your treatment experience with your referring healthcare provider, who will remain an important part of your care

How to Use SPRAVATO® Nasal Spray

You will administer SPRAVATO® yourself under the supervision of a healthcare provider, who will show you how to use the SPRAVATO® nasal spray device.

SPRAVATO® Side Effects

There’s an increased risk of suicidal thoughts and behavior with SPRAVATO®.

Call your healthcare provider right away if you have new or sudden changes in mood, behavior, thoughts or feelings, or if you develop suicidal thoughts or behavior.

SPRAVATO® may cause serious side effects including sedation, dissociation, abuse and misuse, temporary increased blood pressure that may last about four hours after a dose, problems with thinking clearly, and bladder problems, such as a frequent or urgent need to urinate, pain when urinating or urinating frequently at night.

The most common side effects that can occur during and after taking SPRAVATO® include:

  • Feeling disconnected from yourself, your thoughts, feelings and things around you (dissociation)
  • Dizziness
  • Nausea
  • Feeling sleepy (sedation)
  • Spinning sensation
  • Decreased feeling of sensitivity (numbness)
  • Feeling anxious
  • Lack of energy
  • Increased blood pressure
  • Vomiting
  • Feeling drunk
  • Feeling very happy or excited
 

Staying on SPRAVATO®

 

Your First Month and Beyond

You’ll take SPRAVATO® twice a week for the first month. Your doctor will evaluate you at the end of the first month to determine if you should continue with SPRAVATO® treatment. During the second month, you’ll take it once a week. After that, you’ll take it once a week or once every two weeks. You’ll continue to take an oral antidepressant as prescribed.

Next:

Patient Stories

Stories of patients who are living with treatment-resistant depression, and their experiences on SPRAVATO®.

Frequently Asked Questions

To help ensure the safe and appropriate use of SPRAVATO®, it is only available at certified SPRAVATO® treatment centers. Your healthcare provider can refer you to a certified SPRAVATO® treatment center. Even if your current healthcare provider doesn’t directly treat you with SPRAVATO®, they should remain a key partner in helping you with the overall management of your treatment-resistant depression.

After starting SPRAVATO® treatment, make sure your healthcare provider has access to your medical information from the treatment center so that they are aware of how your treatment plan is progressing.

Your first visit to a certified SPRAVATO® treatment center will be a consultation. The treatment center will receive your medical information from your healthcare provider, conduct its own assessment to determine if SPRAVATO® may be right for you, and verify your insurance information as part of the eligibility confirmation. If SPRAVATO® is recommended, the treatment center will build a treatment plan with you and enroll you in the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. You may start treatment on your next visit. You may also be able to get help with insurance matters, scheduling and treatment preparation.

On treatment days, you will administer SPRAVATO® nasal spray yourself under the supervision of a healthcare provider at the treatment center, who will assess your blood pressure before and after you administer SPRAVATO® nasal spray.

After you administer SPRAVATO® nasal spray yourself, there will be an observation period of at least two hours during which you will be allowed to rest comfortably while a healthcare provider monitors you for possible side effects.

Because of possible side effects affecting mental alertness and motor coordination, you won’t be able to drive, operate machinery or do anything where you need to be completely alert until the next day, following a restful sleep. So you’ll need to plan for rides on treatment days.

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

If you have high blood pressure, whether treated or not, you should discuss that specifically with your healthcare provider in deciding whether SPRAVATO® may be right for you. Do not take SPRAVATO® if you have a blood vessel disease (aneurysm), an abnormal connection between your blood vessels (arteriovenous malformation) or a history of bleeding in the brain.

SPRAVATO® can increase your blood pressure temporarily – for about four hours – so you will have your blood pressure measured at various times, including before and after taking SPRAVATO®.

If your blood pressure is high before using this medicine, your healthcare provider will decide whether to start the medicine or wait until your blood pressure is lower.

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®.