Esketamine (es-KET-a-meen)

Treats treatment-resistant depression (TRD) and major depression disorder (MDD) with suicidal ideation or behavior.

Brand Name(s):

Spravato, Spravato 56MG Dose Kit, Spravato 84MG Dose Kit

When This Medicine Should Not Be Used:

How to Use This Medicine:

Spray

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. You will be taking a dose of this medicine under your doctor's supervision in a medical facility.
• Do not eat for at least 2 hours and do not drink for at least 30 minutes before using this medicine.
• Each device contains 2 sprays. Your doctor will tell you how many devices to use depending on your dose.
• To use the device:
  • This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away.
  • Gently blow your nose to clear the nostrils before you use the first device only.
  • Hold the device upright between your thumb and first 2 fingers. Do not press the plunger.
  • Tilt your head back slightly.
  • Insert the device tip into the first nostril. The nose rest should touch the skin between the nostrils.
  • Close the other nostril, then firmly press the plunger all the way up as you slowly breathe through your nose. Sniff gently after spraying.
  • Repeat the steps for the other nostril.
  • If you need to use another device, wait 5 minutes after each device to allow the medicine to be absorbed.
  • If liquid drips down from your nose, dab it with a tissue. Do not blow your nose.
• Your doctor may also want you to stay in the medical facility for at least 2 hours to check for unwanted effects.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: You must use this medicine on a fixed schedule. Call your doctor or pharmacist if you miss a dose.
• Keep the bottle tightly closed when not using it. Store at room temperature, away from heat and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how esketamine works. Tell your doctor if you are using armodafinil, methylphenidate, modafanil, amphetamines, or an MAO inhibitor.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• If you need to take a nasal steroid medicine or decongestant, take these at least 1 hour before using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine.
• Do not breastfeed during treatment with this medicine.
• Tell you doctor if you have liver disease, high blood pressure, heart or blood vessel problems, heart failure, mental illness, or if you have a history of brain problems, heart attack, stroke, or drug abuse.
• This medicine may cause the following problems:
  • Prolonged drowsiness or mental changes, including confusion about identity, place, and time, feeling of unreality, sense of detachment from self or body
  • Lung or breathing problems, including respiratory depression
  • Changes in mood or behavior, including thoughts or behavior of suicide
  • High blood pressure
  • Bladder problems, including ulcer
• This medicine may make you drowsy, confused, or have problems with thinking clearly. Do not drive or do anything else that could be dangerous until the next day after a restful sleep or until you know how this medicine affects you. You may also need someone to drive you home after treatment with this medicine.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody or cloudy urine, difficult or painful urination, frequent urge to urinate
• Blue lips, fingernails, or skin, trouble breathing, chest pain
• Confusion about identity, place, and time
• Lightheadedness, dizziness, or fainting
• Prolonged drowsiness or sleepiness
• Sudden, severe headache, vision changes, seizures, loss of consciousness, memory loss
• Thoughts or attempts of killing yourself or others, changes in behavior

If you notice these less serious side effects, talk with your doctor:

• Change in taste
• Diarrhea, nausea, vomiting
• Itching, burning, or irritation in the nose
• Numbness, tingling, or burning pain in the mouth or throat
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088