Esketamine is a nasal spray that is used together with an oral (taken by mouth) antidepressant to treat adults with depression that is resistant to other treatments.

Esketamine is also used with an antidepressant taken by mouth to treat symptoms of depression in adults with major depressive disorder who have suicidal thoughts or actions. It is not known if esketamine can prevent suicide or reduce thoughts about suicide.

Esketamine is used only in a healthcare setting. You will not be able to use this medicine at home.

Esketamine is for use only under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Esketamine may also be used for purposes not listed in this medication guide.

You should not be treated with medicine if you are allergic to esketamine or ketamine, or if you have:

• a blood vessel disorder affecting your brain, chest, stomach, heart, or arms and legs;
• a history of aneurysm;
• a history of bleeding in your brain; or
• an abnormal connection between your veins and arteries (a condition called arteriovenous malformation).

Tell your doctor if you have ever had:

• heart problems (such as chest pain, heart failure, or a heart valve disorder);
• slow heartbeats that have caused you to faint;
• high blood pressure;
• a heart attack or stroke;
• a brain injury or increased pressure in your brain;
• mental illness or psychosis;
• a family history of depression;
• alcoholism or drug addiction; or
• liver disease.

Some people have thoughts about suicide when first using an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not use if you are pregnant. Esketamine may harm an unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of esketamine on the baby.

You should not breastfeed while using esketamine.

Use Spravato (Nasal) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Your blood pressure will need to be checked before and after you use esketamine. Esketamine can increase your blood pressure for several hours after each dose. Tell your doctor if you have chest pain, trouble breathing, severe headache, blurred vision, pounding in your neck or ears, or a seizure.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Also call your doctor at once if you have:

• extreme drowsiness or feeling like you might pass out;
• severe dizziness or feelings of floating;
• problems with thinking or memory;
• unusual or unpleasant memories (flashbacks);
• hallucinations, feeling "spaced out"; or
• urination problems (painful urination, increased urination, urgent need to urinate).

Common side effects may include:

• dissociation, feeling drunk;
• increased blood pressure;
• drowsiness, lack of energy;
• dizziness, spinning sensation;
• feeling anxious;
• nausea, vomiting; or
• decreased sensations (touch or other senses).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid using any other nasal medicines within 1 hour before you use esketamine nasal spray.

Do not drive yourself or do anything that requires you to be awake and alert until the day after your esketamine dose.