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General Information

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IMPORTANT WARNING:

Using esketamine nasal spray may cause sleepiness (sedation); fainting; dizziness; anxiety; a spinning sensation; or feeling disconnected from your body, thoughts, emotions, space and time; and breathing problems. You will use esketamine nasal spray by yourself in a medical facility, but your doctor will monitor you before, during, and for at least 2 hours after your treatment. You will need to plan for a caregiver or family member to drive you home after using esketamine. After you use esketamine nasal spray, do not drive a car, operate machinery, or do anything where you need to be completely alert until the next day after a restful night's sleep. Tell your doctor right away if you experience any of the following symptoms: extreme tiredness or sleepiness, dizziness, fainting, or shortness of breath or if you feel anxious or disconnected from your body, thoughts, emotions, space, and time.

Esketamine may be habit-forming. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications.

A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children should not use esketamine.

You should know that your mental health may change in unexpected ways when you use esketamine or other antidepressants even if you are an adult over age 24. You may become suicidal, especially at the beginning of your treatment and any time that your dose is changed. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

No matter your age, before you take an antidepressant, you or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

Because of the risks with this medication, esketamine is available only through a special restricted distribution program. A program called Spravato Risk Evaluation and Mitigation Strategies (REMS) program. You, your doctor, and your pharmacy must be enrolled in the Spravato REMS program before you can receive this medication. You will use esketamine nasal spray in a medical facility under the observation of a doctor or other healthcare professional.

Keep all appointments with your doctor and the laboratory.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with esketamine and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website or the manufacturer's website to obtain the Medication Guide.

Use

WHY is this medicine prescribed?

Esketamine nasal spray is used alone or in combination with another antidepressant, taken by mouth, to manage treatment-resistant depression (TRD; depression that does not improve with treatment) in adults. It is also used along with another antidepressant, taken by mouth, to treat depressive symptoms in adults with major depressive disorder (MDD) and suicidal thoughts or actions. Esketamine is in a class of medications called NMDA receptor antagonists. It works by changing the activity of certain natural substances in the brain.

HOW should this medicine be used?

Esketamine comes as a solution (liquid) to spray into the nose. For the management of treatment-resistant depression, it is usually sprayed into the nose twice a week during weeks 1-4, once weekly during weeks 5-8, and then once a week or once every 2 weeks during week 9 and beyond. For the treatment of depressive symptoms in adults with major depressive disorder and suicidal thoughts or actions, it is usually sprayed into the nose twice a week for up to 4 weeks. Esketamine must be used in a medical facility.

Do not eat for at least 2 hours or drink liquids for at least 30 minutes before using esketamine nasal spray.

Each nasal spray device provides 2 sprays (one spray for each nostril). Two green dots on the device tells you that the nasal spray is full, one green dot tells you that one spray was used, and no green dots indicates that the full dose of 2 sprays was used.

Are there OTHER USES for this medication?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Special

What SPECIAL PRECAUTIONS should I follow?

Before using esketamine nasal spray,

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss a treatment session contact your doctor right away to schedule an appointment. If you miss a treatment and your depression becomes worse, your doctor may have to change your dose or treatment schedule.

Side Effects

What SIDE EFFECTS can this medicine cause?

Esketamine nasal spray may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

Some side effects can be serious. If you experience any of the symptoms listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment.

Esketamine nasal spray may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Overdose

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Miscellaneous

What OTHER INFORMATION should I know?

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS® Patient Medication Information Copyright, 2025. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: February 15, 2025.