Esketamine (nasal)

Esketamine is a nasal spray that is used along with an oral (taken by mouth) antidepressant to treat adults with depression that does not respond to other treatments.

Esketamine is also used with an oral antidepressant 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 lessen thoughts about suicide.

Esketamine is used only in a healthcare setting. You will not be able to use esketamine 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.

Esketamine can make you very sleepy, or you may feel detached from your body, thoughts, or surroundings. Esketamine is given only in a healthcare setting where you will be monitored closely for at least 2 hours after each dose. You will need someone to drive you home after using esketamine.

Some people may have thoughts of suicide while taking esketamine. Be aware of any changes in your mood or symptoms. Tell your doctor about any new or worsening symptoms.

You should not be treated with this 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 they first start using an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to any 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.

Get emergency medical help if you notice signs of an allergic reaction: hives; trouble 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 raise your blood pressure for several hours after each dose. Tell your doctor if you experience chest pain, difficulty 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: changes in mood or behavior, 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 harming yourself.

Also call your doctor right away if you have:

• extreme drowsiness or feel 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 of esketamine 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.

Esketamine 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.

Esketamine may cause nausea or vomiting. You should not eat anything for at least 2 hours before using esketamine. 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 esketamine. esketamine 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.

Esketamine 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.

Even if your symptoms improve after the first dose of esketamine, you doctor may want you to be treated for depression in a hospital.

Call your doctor for guidance if you miss an appointment for your esketamine dose.

Since esketamine is given by a healthcare professional in a medical setting, an overdose is unlikely to happen.

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.

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 affect esketamine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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