Uses of Esketamine:

• It is used to treat low mood (depression).

What do I need to tell my doctor BEFORE I take Esketamine?

• If you are allergic to esketamine; any part of esketamine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: A certain type of blood vessel disease (aneurysm) in the brain, chest, abdomen, arms, or legs; arteriovenous malformation; high blood pressure; or liver problems.
• If you have ever had bleeding in the brain.
• If you are pregnant or may be pregnant. Do not take esketamine if you are pregnant.
• If you are breast-feeding. Do not breast-feed while you take esketamine.

This is not a list of all drugs or health problems that interact with esketamine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take esketamine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Esketamine?

• Tell all of your health care providers that you take esketamine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert after a dose. Do not do these things until the next day after you have gotten enough sleep. Someone else will need to drive you home after each dose of esketamine.
• This medicine may cause high blood pressure.
• Your doctor will be watching your blood pressure closely.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• If you need to stop treatment with esketamine, you will need to watch for signs of withdrawal. Tell your doctor if you have any bad effects. If you have questions, talk with your doctor.
• If you are able to get pregnant, talk with your doctor about ways to prevent pregnancy while taking esketamine.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking esketamine, call your doctor right away.

How is this medicine (Esketamine) best taken?

Use esketamine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• For the nose only.
• This medicine will be given in a healthcare setting where you will be watched closely. Follow how to use esketamine as you have been told.
• Blow your nose before use.
• Do not eat food for at least 2 hours before using esketamine. Do not drink liquids for at least 30 minutes before using esketamine.
• If you use other drugs in your nose on the same day you use esketamine, use them at least 1 hour before using esketamine.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Chest pain.
• Shortness of breath.
• Seizures.
• Feeling confused.
• Memory problems or loss.
• Anxiety.
• Feeling the need to pass urine often or right away, pain when passing urine, or passing urine more often at night.

What are some other side effects of Esketamine?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling sleepy.
• Feeling sluggish, drunk, or out of sorts.
• Upset stomach or throwing up.
• Change in taste.
• Headache.
• Numbness or tingling in the mouth.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Esketamine?

• If you need to store esketamine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time esketamine is refilled. If you have any questions about esketamine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Frequently asked questions

• Is Spravato (esketamine) a controlled substance?