Esketamine Nasal Spray

What is this medication?

ESKETAMINE (es KET a meen) treats depression. It is prescribed when other antidepressant medications have not worked.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Spravato

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bleeding in the brain
• Blood vessel disease (including in the brain, chest, arms, legs, or other areas of the body)
• Dementia
• Heart disease
• High blood pressure
• History of head injury
• History of heart attack
• History of irregular heartbeat
• History of stroke
• History of substance use disorder
• Liver disease
• Schizophrenia or other thought disorder
• Suicidal thoughts, plans, or attempt by you or a family member
• An unusual or allergic reaction to esketamine, ketamine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is for use in the nose. You will take it yourself under the supervision of your care team in a healthcare setting. Your care team will show you how to use the nasal spray device, how much to take, and when to take it. During and after each treatment, you will be checked by your care team who will decide when you can go home. You will need to plan for a caregiver or family member to drive you home each time after taking the medication. Do not drive or perform other tasks that require complete mental alertness until the day following your treatment after a restful sleep. Because this medication can cause nausea and vomiting, you should not eat for at least 2 hours before taking this medication or drink liquids for at least 30 minutes before taking this medication. If you take a nasal corticosteroid or nasal decongestant, take these medications at least 1 hour before your treatment. Do not stop your treatment except on your care team's advice.

A special MedGuide will be given to you by the pharmacist with each prescription. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. This medication is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

What may interact with this medication?

This medication may interact with the following:

• Alcohol
• Antihistamines for allergy, cough, and cold
• Certain medications for anxiety or sleep
• Certain medications for depression like amitriptyline, fluoxetine, sertraline
• Certain medications for seizures like phenobarbital, primidone
• General anesthetics like halothane, isoflurane, methoxyflurane, propofol
• Ketamine
• Local anesthetics like lidocaine, pramoxine, tetracaine
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Medications that relax muscles for surgery
• Narcotic medications for pain
• Phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• Psychostimulants like amphetamines, methylphenidate, dexmethylphenidate, modafinil, or armodafinil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication. Tell your care team if your symptoms do not start to get better or if they get worse.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until the day following your treatment after a restful sleep. Do not stand up or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Avoid alcoholic drinks; they can make you dizzier.

There is a risk for abuse and dependence when using this medication. Your care team should check you for signs of abuse and dependence before and during treatment with this medication. Your care team can tell you more about the difference between dependence and Substance abuse disorder.

Your care team must monitor you for serious side effects for at least 2 hours after each treatment with this medication. Your care team will decide when you are ready to leave the healthcare setting and return home. Tell your care team right away if you feel like you cannot stay awake or if you feel like you are going to pass out.

Women should inform their care team if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Women should not breast-feed their infant while taking this medication. This medication passes into breast milk and may cause harm to a nursing infant.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Feeling disconnected from your thoughts, feelings, and surroundings
• Increase in blood pressure
• Thoughts of suicide or self-harm, worsening mood, or feelings of depression

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Anxiety or nervousness
• Difficulty with paying attention, memory, or speech
• Dizziness
• Drowsiness
• Extreme feeling of happiness or joy, intense excitement
• Nausea
• Numbness, decrease in sense of touch or sensation
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.