Spravato is a nasal spray that is used together with medication taken by mouth to treat adults with depression that is resistant to to other treatments.

Spravato is also used to treat depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions.

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

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

Spravato can cause severe drowsiness, or feelings of being disconnected from your body or thoughts or surroundings. Spravato is used only in a healthcare setting where you can be watched closely for at least 2 hours after each dose.

You will need someone to drive you home after using Spravato.

Some people have thoughts about suicide while taking Spravato. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

There is a risk for abuse and dependence with esketamine treatment. Your healthcare provider should check you for signs of abuse and dependence before and during treatment with this medicine. 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 is only available through a restricted program called the Spravato Risk Evaluation and Mitigation Strategy (REMS) Program. This medicine an only be administered at healthcare settings certified in the REMS Program and to patients enrolled in the program.

Spravato may cause worsening of depression and suicidal thoughts and behaviors, especially during the first few months of treatment and when the dose is changed. Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.

Spravato is a nasal spray that is used in a healthcare setting. You will give yourself the nasal spray while being supervised by a healthcare professional.

Spravato may cause nausea or vomiting. You should not eat anything for at least 2 hours before receiving your dose. Avoid drinking liquids within 30 minutes before using the medicine.

Read and carefully follow any Instructions for Use that are given to you. Ask your doctor or caregivers if you do not understand these instructions.

You will be watched closely for at least 2 hours after you use Spravato. This medicine can cause side effects such as severe drowsiness, or dissociation (a sense of being detached from your body or emotions, distortions in how you perceive things or people around you).

Your caregivers will decide when you are ready to leave after using this medicine. You will need someone to drive you home. You should not plan to drive yourself anywhere until the next day, after a full night's sleep.

Spravato is usually given 2 times per week at first, and then once every 1 to 2 weeks. Your doctor will tell you how often you need to use the medicine.

Usual Adult Dose for Depression:

INDUCTION PHASE:
Weeks 1 to 4:
-Day 1: 56 mg intranasally ONCE
-Subsequent doses: 56 to 84 mg intranasally 2 times a week

MAINTENANCE PHASE:
Weeks 5 to 8: 56 to 84 mg intranasally once a week
Week 9 and after: 56 to 84 mg intranasally every 2 weeks OR once a week

Comments:
-IMPORTANT CONSIDERATION: Treatment sessions should be directly supervised by a healthcare provider; treatment sessions should include nasal administration of the dose and post-administration observation.
-Patients who require nasal corticosteroids/decongestants should use the agent(s) at least 1 hour before using this drug.
-Patients should be advised to avoid eating foods for at least 2 hours before, and to avoid drinking liquids for at least 30 minutes before administration.
-After the induction phase, evidence of therapeutic benefit should be evaluated to determine the need for continued treatment.
-After Week 8, the dosing frequency should be individualized to the least frequent dosing to maintain remission.

Use: In combination with an oral antidepressant for the treatment of treatment-resistant depression (TRD)

Usual Adult Dose for Depressive Disorder, Other:

84 mg intranasally 2 times a week for 4 weeks
-After 4 weeks, evidence of therapeutic benefit should be evaluated to determine the need for continued treatment.

Comments:
-The dosage may be decreased to 56 mg intranasally 2 times a week if intolerable symptoms occur.
-LIMITATION OF USE: Efficacy in suicide prevention or in reducing suicidal behavior or ideation has not been demonstrated beyond 4 weeks; this drug does not preclude hospitalization if clinically warranted, even if patients improve after an initial dose of treatment.
-IMPORTANT CONSIDERATION: Treatment sessions should be directly supervised by a healthcare provider; treatment sessions should include nasal administration of the dose and post-administration observation.
-Patients who require nasal corticosteroids/decongestants should use the agent(s) at least 1 hour before using this drug.
-Patients should be advised to avoid eating foods for at least 2 hours before, and to avoid drinking liquids for at least 30 minutes before administration.

Use: In combination with an oral antidepressant for the treatment of depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior

Usual Adult Dose for Major Depressive Disorder:

84 mg intranasally 2 times a week for 4 weeks
-After 4 weeks, evidence of therapeutic benefit should be evaluated to determine the need for continued treatment.

Comments:
-The dosage may be decreased to 56 mg intranasally 2 times a week if intolerable symptoms occur.
-LIMITATION OF USE: Efficacy in suicide prevention or in reducing suicidal behavior or ideation has not been demonstrated beyond 4 weeks; this drug does not preclude hospitalization if clinically warranted, even if patients improve after an initial dose of treatment.
-IMPORTANT CONSIDERATION: Treatment sessions should be directly supervised by a healthcare provider; treatment sessions should include nasal administration of the dose and post-administration observation.
-Patients who require nasal corticosteroids/decongestants should use the agent(s) at least 1 hour before using this drug.
-Patients should be advised to avoid eating foods for at least 2 hours before, and to avoid drinking liquids for at least 30 minutes before administration.

Use: In combination with an oral antidepressant for the treatment of depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior

You should not use Spravato 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).

To make sure Spravato is safe for you, tell your doctor if you have:

• 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;

• suicidal thoughts or actions;

• 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 Spravato 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.

Do not breastfeed while using Spravato.

Call your doctor for instructions if you miss an appointment for your Spravato dose.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

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

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

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

Your blood pressure will need to be checked before and after you use Spravato. 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.

Also call your doctor at once if you have:

• extreme drowsiness or feeling like you might pass out;

• severe dizziness or feelings of floating;

• unusual changes in mood or behavior;

• thoughts of hurting yourself;

• worsening depression;

• sleep problems;

• 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 Spravato side effects may include:

• dissociation, feeling drunk;

• increased blood pressure;

• drowsiness;

• 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.

Tell your doctor about all your other medicines, especially:

• opioid medication;

• a sleeping pill or a muscle relaxer;

• medicine for anxiety, such as diazepam, Valium, Xanax, and others;

• stimulant medicine, including diet pills, or ADHD medication such as Adderall or Ritalin;

• medicine to treat narcolepsy; or

• an MAO inhibitor, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

This list is not complete. Other drugs may interact with esketamine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.