Sorry, you need to enable JavaScript to visit this website.

IFU: Treatment-Resistant Depression (TRD) | SPRAVATO® (esketamine)
Instructions for Use

Instructions for Use How to use SPRAVATO® nasal spray

You will administer SPRAVATO® nasal spray yourself under the supervision of a healthcare provider at a certified SPRAVATO® treatment center. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device.

Watch the video to learn more about using the nasal spray.

SUPER: Welcome

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

SUPER: How to use

Speaker: In this video, you’ll learn how to use SPRAVATO®.

SUPER: Treatment-resistant depression

SUPER: Depressive symptoms in adults with major depressive disorder with suicidal thoughts or actions

Speaker/SUPER: SPRAVATO® is a prescription medicine, taken along with an oral antidepressant, for adults with treatment-resistant depression; and for 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 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.

Speaker: SPRAVATO® can cause serious side effects, including sedation and dissociation. There is a risk for abuse and misuse with SPRAVATO®. Be sure to tell your healthcare provider about your complete medical history, including if you have any 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.

You’ll administer SPRAVATO® yourself at a certified SPRAVATO® treatment center under the supervision of a healthcare provider who will show you how to use the nasal spray.

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. 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 any such changes occur. Please see the Important Safety Information in this video, and full Prescribing Information, including Boxed WARNINGS, on SPRAVATO.com.

SUPER: A look at the SPRAVATO® Nasal Spray

Speaker: Let’s review the instructions for using SPRAVATO® now.

Super:

Top
Nose rest
Indicator
Finger rest
Plunger

Speaker: Looking at the nasal spray, you’ll see the top, nose rest, indicator, finger rest and plunger.

SUPER: Contains two sprays

Speaker: Each nasal spray contains two sprays inside, one spray for each nostril.

SUPER: Indicator

Speaker: Now, let’s look at the indicator window.

SUPER: Full

Speaker: Two green dots mean the nasal spray is full.

SUPER: One spray delivered

Speaker: One green dot indicates that one spray was delivered.

SUPER: Empty

Speaker: If there are no green dots, the nasal spray container is empty.

SUPER: Before your first device only

Speaker: Before administering your first device only, blow your nose to clear your nostrils.

SUPER: Hold like this

Speaker: Now, hold the nasal spray as shown with your thumb gently supporting the plunger. Be careful not to press the plunger just yet.

SUPER: Tilt head about 45 degrees

Speaker: Tilt your head back at about 45 degrees throughout the administration. This will keep the medication inside your nose.

SUPER: Insert top into first nostril

Speaker: Next, insert the top into your first nostril, like this. The nose rest should touch the skin between the nostrils as shown.

SUPER: Close opposite nostril

Speaker: Before you spray, use your finger to close the opposite nostril.

SUPER: You’re ready to spray

Speaker: Now, breathe in through your nose while pushing the plunger all the way up until it stops.

SUPER: Sniff gently

Speaker: Sniff gently after spraying to keep the medication inside your nose.

SUPER: Repeat in the second nostril

Speaker: Now, repeat the same steps to administer SPRAVATO® into your second nostril. Keep your head tilted back at a 45-degree angle, switch hands and insert the top of the nasal spray into your second nostril, making sure the nose rest is touching the skin between the nostrils.

SUPER: You’re ready to spray

Speaker: Use your finger to close the opposite nostril, then breathe in through your nose while pushing the plunger all the way up until it stops.

SUPER: Sniff gently

Speaker: Sniff gently to keep the medication inside your nose.

After administering SPRAVATO®, your healthcare provider will check the indicator window to ensure there are no green dots, confirming that all the medication has been administered.

SUPER: 5 min rest between devices

Speaker: It’s important that you rest in a comfortable position, preferably semi-reclined, for five minutes between devices to allow the medication to absorb.

SUPER: Do not blow your nose

Speaker: Do not blow your nose. If liquid drips out, dab your nose with a tissue.

SUPER: Observation period

Speaker: After you get your full dose of SPRAVATO®, you will be monitored for at least two hours. You may want to listen to music, read or just relax while a healthcare provider monitors your blood pressure and checks for possible side effects. Other serious side effects may include problems with thinking clearly and bladder problems.

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. Tell your healthcare provider if you experience any side effects while taking SPRAVATO®. Please see the Important Safety Information in this video, and full Prescribing Information, including Boxed WARNINGS, on SPRAVATO.com.

Speaker: After the observation period, when your healthcare provider gives you the okay, you’ll be ready to leave. Keep in mind you won’t be able to drive, operate machinery or do anything where you need to be completely alert after taking SPRAVATO® until the next day, following a restful sleep, so you will need to plan for rides on treatment days.

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:

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-170363v1

SUPER:

© Janssen Pharmaceuticals, Inc. 2022. All rights reserved.  01/22  cp-153444v3

Return to:

Preparing for Treatment

The SPRAVATO® treatment plan. 
A different treatment experience.