SPRAVATO® Frequently Asked Questions (FAQs)

 

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 healthcare provider 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 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.

These are not all the conditions you should tell your healthcare provider about before starting SPRAVATO®. For a full list of conditions, please see the Medication Guide.

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 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.

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

The most common side effects 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; and feeling very happy or excited.

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 Important Safety Information, full Prescribing Information and Medication Guide.

It is very important to make every effort to stay on the treatment plan that you and your healthcare provider have made. However, if you do miss a treatment, contact your healthcare provider as soon as possible to discuss how they would like to address this situation. Your healthcare provider may decide to change your dose, or dosing frequency, because of missed treatments.

You and your healthcare provider will decide how long you stay on SPRAVATO® based on how you respond to it and how stable that response is. Your healthcare provider 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 depressive symptoms was demonstrated at four weeks by SPRAVATO® plus an oral antidepressant, compared with placebo nasal spray plus an oral antidepressant. Not all patients will respond to SPRAVATO®.

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

Sedation (feeling sleepy) and dissociation (feeling disconnected from yourself, your thoughts, feelings and things around you) are among the possible serious side effects during and after taking SPRAVATO®, and you should expect your healthcare provider 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.

You should discuss your plans for the remainder of the day with your healthcare provider. 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 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 healthcare provider may decide that you complete the first four weeks of SPRAVATO® treatment to see whether or not you have had satisfactory improvement of depressive symptoms. If you’ve done this, talk to all of the healthcare providers involved in the management of your treatment about appropriate next steps. Do not stop your SPRAVATO® treatments without first discussing your reasons and concerns with your healthcare provider and formulating a treatment plan with them.

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 medication, 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®.

SPRAVATO® (esketamine) CIII nasal spray is the first prescription nasal spray, taken with an oral antidepressant, for:

  • Adults with treatment-resistant depression
  • Depressive symptoms in adults with major depressive disorder 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 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.

Healthcare providers may define the term “treatment-resistant depression” differently. In the SPRAVATO® clinical trials, treatment-resistant depression was diagnosed in adults who were struggling with major depressive disorder and had not responded adequately to at least two different antidepressants of adequate dose and duration in the current depressive 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.

The safety and benefits of SPRAVATO® nasal spray, taken 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 healthcare provider 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 healthcare provider if you have a history of abusing prescription or street drugs, or a problem with alcohol. You should also tell your healthcare provider if you are pregnant, planning to become pregnant, are breastfeeding or planning to breastfeed. Do not take SPRAVATO® if you are pregnant or breastfeeding. 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®. Talk to your healthcare provider about all of your health conditions and medicines when discussing treatment with SPRAVATO®.

Do NOT take SPRAVATO® if any of the following applies 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 a 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 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.

No, treatment with SPRAVATO® is not recommended during pregnancy or while breastfeeding. SPRAVATO® may harm your baby. You should let your healthcare provider 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 healthcare provider about methods of birth control that should be used.

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

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.

SPRAVATO® (esketamine) CIII nasal spray is a derivative of ketamine. SPRAVATO® is an FDA-approved nasal spray for treatment-resistant depression; it is also approved to treat depressive symptoms in adults with major depressive disorder with suicidal thoughts or actions. Ketamine has not been approved by the FDA to treat depression. Both SPRAVATO® and ketamine are Schedule III controlled substances under the US Controlled Substances Act.

First, talk to your healthcare provider about whether SPRAVATO® is right for you. If your healthcare provider 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 provider.

Want to learn more about the SPRAVATO® treatment process?

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 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 healthcare provider 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 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.

These are not all the conditions you should tell your healthcare provider about before starting SPRAVATO®. For a full list of conditions, please see the Medication Guide.

You can only get SPRAVATO® at certified SPRAVATO® treatment centers; ask your healthcare provider to help find a location. 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.

If you change the location of your certified SPRAVATO® treatment center during your treatment, your healthcare provider should contact the new treatment center to ensure it is able to accept you as a patient, and that it takes your insurance.

Sure! for notifications about new certified SPRAVATO® treatment centers opening near you.

You cannot take SPRAVATO® on your own. You will administer SPRAVATO® nasal spray yourself under the supervision of a healthcare provider, at a certified SPRAVATO® treatment center. You can choose the location that works best for you; ask your healthcare provider to help find a location. 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.

On your first visit to a certified SPRAVATO® treatment center, a healthcare provider will typically do their own assessment to decide if SPRAVATO® is right for you. So you shouldn’t expect treatment on your first visit. If SPRAVATO® is recommended, your healthcare provider will discuss the risks of misuse, abuse, sedation and dissociation 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. Your healthcare provider 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.

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

Sedation (feeling sleepy) and dissociation (feeling disconnected from yourself, your thoughts, feelings and things around you) are among the possible serious side effects during and after taking SPRAVATO®, and you should expect your healthcare provider 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.

You should discuss your plans for the remainder of the day with your healthcare provider. 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, 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 healthcare provider 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 depressive symptoms was demonstrated at four weeks by SPRAVATO® plus an oral antidepressant, compared with placebo nasal spray plus an oral antidepressant. Not all patients will respond to SPRAVATO®.

At each visit, your healthcare provider(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 provider(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 your referring healthcare provider is not the same provider treating you with SPRAVATO®, you should ask when, and in what way, your new healthcare provider will be letting your referring provider 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 healthcare provider will decide how long you stay on SPRAVATO® based on how you respond to it and how stable that response is. Your healthcare provider 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 healthcare provider have made. However, if you do miss a treatment, contact your healthcare provider as soon as possible to discuss how they would like to address this situation. Your healthcare provider may decide to change your dose, or dosing frequency, because of missed treatments.

You should ask your healthcare providers what else you might do, beyond taking SPRAVATO® and your oral antidepressant, to help manage your treatment-resistant depression. If your healthcare provider 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 depressive symptoms.

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

Not all patients will respond to SPRAVATO®. Your healthcare provider may decide that you complete the first four weeks of SPRAVATO® treatment to see whether or not you have had satisfactory improvement of depressive symptoms. If you’ve done this, talk to all of the healthcare providers involved in the management of your treatment about appropriate next steps. Do not stop your SPRAVATO® treatments without first discussing your reasons and concerns with your healthcare provider 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 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.

Other possible serious side effects include 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

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 Important Safety Information, full Prescribing Information and Medication Guide.

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

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 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®.

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®.

You should discuss your plans for the remainder of the day with your healthcare provider. 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 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 and things around you (dissociation). For these reasons, do not drive, operate machinery or do anything where you need to be completely alert 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 provider 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 providers 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 provider your health plan benefits, insurance coverage and out-of-pocket costs.

Janssen CarePath Savings Program for SPRAVATO®

Eligible patients with commercial insurance can receive 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.