Frequently Asked Questions

Frequently Asked Questions

 

Some patients taking SPRAVATO™ may experience nausea or vomiting. Because of this, you should avoid eating two hours before, and drinking liquids 30 minutes before, treatment.

Before you take SPRAVATO™, talk to your doctor about your full medical and depression treatment history, including 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 are allergic to esketamine, ketamine or any of the ingredients in SPRAVATO™.

Be sure to tell your doctor if you have any heart (e.g., high blood pressure) or brain problems (e.g., stroke or history of brain injury), liver problems, psychosis, are pregnant or plan to become pregnant or are 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.

Serious side effects reported with SPRAVATO™ include sedation and dissociation, and there is a risk of abuse and misuse with SPRAVATO™.

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

Call your doctor right away if you have new or sudden changes in mood, behavior, thoughts or feelings.

Other possible serious side effects include increased blood pressure, problems with thinking clearly or bladder problems.

The most common side effects include:

  • Dissociation, dizziness, nausea, sedation, spinning sensation, reduced sense of touch and sensation, anxiety, lack of energy, increased blood pressure, vomiting and feeling drunk

Because of the possibility of nausea and vomiting, you should avoid eating two hours before, and drinking liquids 30 minutes before, taking SPRAVATO™.

These are not all the possible side effects of SPRAVATO™. For more information, please see the full Important Safety Information.

It is very important to make every effort to stay on the treatment plan that you and your doctor have made. However, if you do miss a treatment, contact your doctor as soon as possible to discuss how they would like to address this situation. It is possible that your dose or dosing frequency may be changed if you’ve missed more than one or two treatments.

You and your doctor will decide how long you stay on SPRAVATO™, based on how you respond to it and how stable that response is. Your doctor will determine the dosing frequency based on how you feel.

You’ll take SPRAVATO™ twice a week for the first month. 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 your oral antidepressant as prescribed.

In clinical studies, improvement of depression symptoms was demonstrated at four weeks by SPRAVATO™ plus an oral antidepressant, compared with placebo nasal spray plus an oral antidepressant.

The observation period is a time right after you administered SPRAVATO™, when you will be allowed to comfortably rest, and during which a healthcare professional will check for any treatment side effects that you might experience. The observation period will last for at least two hours.

Sedation and dissociation (feeling disconnected from yourself, your thoughts, feelings, space and time) are among the possible serious side effects during and after taking SPRAVATO™, and you should expect your healthcare professional to ask you about these possible side effects during this period. You should expect to have your blood pressure checked before starting treatment and periodically during the observation period, as some people treated with SPRAVATO™ have a temporary increase in blood pressure after treatment.

Once your healthcare professional gives you the okay to leave, you should discuss your plans for the remainder of that day, and which activities are or are not appropriate. You should not drive or operate machinery until the day after a treatment session, following a restful sleep, even if you think you feel well enough to do so. Because of this driving restriction, you will need to plan for your rides on treatment days.

Not all patients will respond to SPRAVATO™. Your doctor may decide that you complete the first four weeks of SPRAVATO™ treatment to see whether or not you have had satisfactory depression-symptom improvement. If you’ve done this, talk to all of the healthcare professionals involved in the management of your treatment-resistant depression about appropriate next steps. Do not stop your SPRAVATO™ treatments without first discussing your reasons and concerns with your doctor and formulating a treatment plan with them.

If you have high blood pressure, whether treated or not, you should discuss that specifically with your doctor in deciding whether SPRAVATO™ may be right for you. Do not take SPRAVATO™ if you have a blood vessel disease (aneurysm) or 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. Your blood pressure will be measured before you start taking SPRAVATO™ and after taking it.

Your doctor will decide whether SPRAVATO™ is the right medication for you.

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™.

SPRAVATO™ (esketamine) CIII nasal spray is a prescription medicine, used along with an antidepressant taken by mouth, for treatment-resistant depression (TRD) in adults.

Doctors may define the term treatment-resistant depression differently. In the SPRAVATO™ clinical trials, treatment-resistant depression was defined as adults who are currently struggling with major depressive disorder and have not responded adequately to at least two different antidepressants of adequate dose and duration in the current episode.

Oral antidepressant medications commonly used today are thought to treat depression by increasing levels of neurotransmitters (serotonin, norepinephrine and dopamine) in areas of the brain that affect mood.

SPRAVATO™ targets the N-methyl-D-aspartate (NMDA) receptor and is believed to work differently than currently available oral antidepressants. The exact way that SPRAVATO™ works is unknown. SPRAVATO™ is taken with a daily oral antidepressant.

The safety and benefits of SPRAVATO™ nasal spray, given with an oral antidepressant, were studied in a clinical program involving short- and long-term trials across more than 1,700 adult patients with treatment-resistant depression that compared SPRAVATO™ plus an oral antidepressant to a placebo nasal spray plus an oral antidepressant. These studies evaluated the efficacy and safety of SPRAVATO™, both short-term and long-term for up to one year, for treatment-resistant depression.

Talk to your doctor to see if SPRAVATO™ may be right for you. SPRAVATO™ is a prescription medicine given by nasal spray and taken with an oral antidepressant to improve the symptoms of depression in adults who have treatment-resistant depression. Be sure to tell your doctor if you have a history of abusing prescription or street drugs, or a problem with alcohol. You should also tell your doctor if you are pregnant, planning to become pregnant, are breastfeeding or planning to breastfeed. 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 are allergic to esketamine, ketamine or any of the ingredients in SPRAVATO™. Talk to your doctor about all of your health conditions and medicines when discussing treatment with SPRAVATO™.

Do NOT take SPRAVATO™ if any of the following apply to you:

You are allergic to esketamine, a similar medicine called ketamine used for anesthesia, or any of the other ingredients in SPRAVATO™.

You have had medical conditions such as blood vessel disease (aneurysm), an abnormal connection between your blood vessels (arteriovenous malformation) or a history of bleeding in the brain.

Be sure to tell your doctor if you have any heart (e.g., high blood pressure) or brain problems (e.g., stroke or history of brain injury), liver problems, psychosis, are pregnant or plan to become pregnant or are 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.

No, treatment with SPRAVATO™ is not recommended during pregnancy or while breastfeeding. You should let your doctor know if you are pregnant, planning to become pregnant, breastfeeding or planning to breastfeed. If you are a woman planning to start SPRAVATO™, and are of childbearing age, you should use highly effective contraception while taking SPRAVATO™. Talk with your doctor about methods of birth control that should be used.

If you become pregnant while being treated with SPRAVATO™, you should talk to your doctor as soon as possible about discontinuing treatment and about other options for treating your depression.

SPRAVATO™ (esketamine) CIII nasal spray is a derivative of ketamine. SPRAVATO™ is an FDA-approved nasal spray for treatment-resistant depression. Intravenous (IV) ketamine has not been approved by the FDA to treat depression. Both SPRAVATO™ and ketamine are Schedule III controlled substances under the U.S. Controlled Substances Act.

First, talk to your doctor about whether SPRAVATO™ is right for you. If your doctor is not set up for treating with SPRAVATO™, they can help you find a certified SPRAVATO™ treatment center where you can self-administer SPRAVATO™ nasal spray under the supervision of a healthcare professional.

Want to learn more about the SPRAVATO™ treatment process?

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

Before you take SPRAVATO™, talk to your doctor about your full medical and depression treatment history, including 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 are allergic to esketamine, ketamine or any of the ingredients in SPRAVATO™.

Be sure to tell your doctor if you have any heart (e.g., high blood pressure) or brain problems (e.g., stroke or history of brain injury), liver problems, psychosis, are pregnant or plan to become pregnant or are 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.

You can only get SPRAVATO™ at certified SPRAVATO™ treatment centers. Ask your doctor to help find a location. 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 and to patients enrolled in the program.

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You cannot take SPRAVATO™ on your own. You will administer SPRAVATO™ nasal spray yourself under the supervision of a healthcare professional, at a certified SPRAVATO™ treatment center. You can choose the location that works best for you. SPRAVATO™ cannot be purchased at a pharmacy. 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 and to patients enrolled in the program.

On your first visit to a certified SPRAVATO™ treatment center, a healthcare professional will typically do their own assessment to confirm that SPRAVATO™ is right for you. So you shouldn’t expect treatment on your first visit. You may also be able to get help with insurance matters, scheduling and treatment preparation. 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 and to patients enrolled in the program.

On treatment days, you will administer SPRAVATO™ nasal spray yourself under the supervision of a healthcare professional. Your healthcare professional will assess your blood pressure prior to 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 comfortably rest while a healthcare professional monitors you for possible side effects.

Your healthcare professional is there to ensure that any side effects you might experience resolve before you leave the certified SPRAVATO™ treatment center. Before you go, talk to your doctor about your plans for the remainder of the day to decide which activities may or may not be appropriate.

You won’t be able to drive or operate machinery that requires you 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 professional if you have any side effect that bothers you or does not go away.

The observation period is a time right after a treatment when you will be allowed to comfortably rest, and during which a healthcare professional will check for any treatment side effects that you might experience.

Sedation and dissociation (feeling disconnected from yourself, your thoughts, feelings, space and time) are among the possible serious side effects during and after taking SPRAVATO™, and you should expect your healthcare professional to ask you about these possible side effects during this period. You should expect to have your blood pressure checked periodically during the observation period, as some people treated with SPRAVATO™ have an increase in blood pressure after treatment.

Once your healthcare professional gives you the okay to leave, you should discuss your plans for the remainder of that day, and which activities are or are not appropriate. You should not drive or operate machinery until the day after a treatment session, following a restful sleep, even if you think you feel well enough to do so. Because of this driving restriction, you will need to plan for your rides on treatment days.

You can discuss with your doctor at the certified SPRAVATO™ treatment center the specific personal items you might like to bring with you. These items might include headphones, a music player, a tablet, crossword puzzles or a book to pass the time, and a blanket and pillow to help you relax.

In clinical studies, improvement of depression symptoms was demonstrated at four weeks by SPRAVATO™ plus an oral antidepressant, compared with placebo nasal spray plus an oral antidepressant.

At each visit, your healthcare professional(s) will ask about your symptoms of depression, side effects and whether or not you are experiencing noticeable improvement. In the clinical studies of SPRAVATO™, a standardized scale called the Montgomery Åsberg Depression Rating Scale was used to track treatment-resistant depression symptoms and response to treatment.

It’s a good idea to ask your healthcare professional(s) at the start of SPRAVATO™ treatment how they will be evaluating your response to treatment, and what you can do to help with that. If the referring doctor who has been helping you with the overall management of your treatment-resistant depression is not the same professional treating you with SPRAVATO™, you should ask that doctor when, and in what way, they will be letting your referring doctor know how your treatments are going and how you are doing.

You’ll take SPRAVATO™ twice a week for the first month. 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 will continue to take your oral antidepressant as prescribed.

You and your doctor will decide how long you stay on SPRAVATO™, based on how you respond to it and how stable that response is. Your doctor will determine the dosing frequency based on how you feel.

It is very important to make every effort to stay on the treatment plan that you and your doctor have made. However, if you do miss a treatment, contact your doctor as soon as possible to discuss how they would like to address this situation. It is possible that your dose, or dosing frequency, may be changed if you’ve missed more than one or two treatments.

You should ask your healthcare professionals what else you might do, beyond taking SPRAVATO™ and your oral antidepressant, to help manage your treatment-resistant depression. If your doctor has included some form of talk therapy in your treatment plan, you should continue that. Some people find that lifestyle changes, including exercise, dietary changes and better sleep can also help decrease depression symptoms.

You should let all the doctors involved in your care know how your treatments are going and how you are doing – especially if the doctor helping with the overall management of your treatment-resistant depression is not the same person who is treating you with SPRAVATO™.

Not all patients will respond to SPRAVATO™. Your doctor may decide that you complete the first four weeks of SPRAVATO™ treatment to see whether or not you have had satisfactory depression-symptom improvement. If you’ve done this, talk to all of the healthcare professionals involved in the management of your treatment-resistant depression about appropriate next steps. Do not stop your SPRAVATO™ treatments without first discussing your reasons and concerns with your doctor and formulating a treatment plan with them.

Serious side effects reported with SPRAVATO™ include sedation and dissociation, and there is a risk of abuse and misuse with SPRAVATO™.

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

Call your doctor right away if you have new or sudden changes in mood, behavior, thoughts or feelings.

Other possible serious side effects include: temporary increased blood pressure that may last about four hours after a dose, problems with thinking clearly or 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:

  • Dissociation (feeling disconnected from yourself, your thoughts, feelings, space and time)
  • Dizziness
  • Nausea
  • Sedation (sleepiness)
  • Spinning sensation
  • Reduced sense of touch and sensation
  • Anxiety
  • Lack of energy
  • Increased blood pressure
  • Vomiting
  • Feeling drunk

If these common side effects occur, they usually happen right after taking SPRAVATO™ and go away the same day.

Because of the possibility of nausea and vomiting, you should avoid eating two hours before, and drinking liquids 30 minutes before, taking SPRAVATO™.

These are not all the possible side effects of SPRAVATO™. For more information, please see the full Important Safety Information

Seven percent of patients experienced nasal crusting, discomfort, dryness and/or itchiness related to treatment with SPRAVATO™. If you are using another nasal spray medicine or prescription, such as a nasal steroid or decongestant spray, you should not administer these within the hour before you will be taking SPRAVATO™.

If you have high blood pressure, whether treated or not, you should discuss that specifically with your doctor in deciding whether SPRAVATO™ may be right for you. Do not take SPRAVATO™ if you have had medical conditions such as 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 doctor 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™.

Before starting 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 medicines or alcohol may cause side effects. Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants or monoamine oxidase inhibitor (MAOI) medicines. If you use a nasally administered medication like a nasal steroid or decongestant spray, do not administer it within the hour before you will be taking SPRAVATO™.

Some patients taking SPRAVATO™ may experience nausea or vomiting. Because of this, you should avoid eating two hours before, and drinking liquids 30 minutes before, taking SPRAVATO™.

Once your healthcare professional gives you the okay to leave, you should discuss your plans for the remainder of that day, and which activities are or are not appropriate. You should not drive or operate machinery until the day after a treatment session, following a restful sleep, even if you think you feel well enough to do so. Because of this driving restriction you will need to plan for your rides on treatment days.

SPRAVATO™ may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation). For these reasons, do not drive or operate machinery until the day after a treatment session, following a restful sleep, even if you think you feel well enough to do so.

The team at your certified SPRAVATO™ treatment center may be able to assist you in determining your specific insurance coverage for SPRAVATO™ and potential out-of-pocket costs of treatment. Janssen CarePath can also help in reviewing with you and your healthcare professional your health plan benefits, insurance coverage and out-of-pocket costs.

To learn more about your insurance coverage for SPRAVATO™ and other resources, please call a Janssen CarePath Care Coordinator at 844-777-2828 or visit JanssenCarePath.com.

The healthcare professionals at your certified SPRAVATO™ treatment center may be able to assist you in determining your insurance coverage for SPRAVATO™ and potential out-of-pocket costs of treatment. Janssen CarePath can also help in reviewing with you and your healthcare professional your health plan benefits, insurance coverage and out-of-pocket costs.

Janssen CarePath Savings Program for SPRAVATO™

Eligible patients with commercial insurance can receive instant savings on out-of-pocket medication costs for SPRAVATO™. Janssen CarePath can provide information about this program as well as other resources that may be able to help with your out-of-pocket medication costs for SPRAVATO™.

Not valid for patients using Medicare, Medicaid or other government-funded programs to pay for their medications. Terms expire at the end of each calendar year and may change. For full eligibility requirements, click here.