Spravato 84 mg (28 mg x 3) nasal spray

Generic name:
Esketamine nasal - spray

Pronunciation
(es-KET-a-meen)

Brand name(s)
Spravato

Esketamine is given in a doctor's office or medical clinic. This medication may cause drowsiness, dizziness, fainting, anxiety, or serious (possibly fatal) slow/shallow breathing. It may also cause you to feel disconnected from your body, thoughts, feelings, space, and time (dissociation). You must be monitored for at least 2 hours after each treatment by a health care professional to make sure these side effects go away and it is safe for you to leave the medical clinic or doctor's office.

This medication also has a risk for abuse and physical and psychological dependence. See also How to Use section.

To receive esketamine in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

This medication is used along with an antidepressant taken by mouth to treat depression in adults. Esketamine is thought to work by affecting the balance of a certain natural substance (glutamate) in the brain.

See also Warning section.

Read the Medication Guide provided by your pharmacist before you start using esketamine and each time you go for treatment. If you have any questions, ask your doctor or pharmacist.

To reduce the risk of nausea and vomiting, avoid food for at least 2 hours before treatment, and avoid drinking liquids for at least 30 minutes before treatment.

If you have a stuffy nose, ask your doctor if you should use a corticosteroid spray or decongestant drops/spray in your nose at least 1 hour before esketamine treatment.

A health care professional will give you instructions for how to use the nasal spray device. Blow your nose before you start treatment. You may need to use more than one spray device based on your dose. Spray once in each nostril per device. Lean your head back and rest for 5 minutes after using each device. Do not blow your nose right after a dose.

You will be monitored during each treatment and afterward for at least 2 hours. You will need to have someone drive you home after each treatment.

The dosage and treatment schedule are based on your medical condition and response to treatment. Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as cravings, tiredness, poor appetite, anxiety). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used esketamine for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Tell your doctor if your condition does not get better or if it gets worse.

See also Warning and How to Use sections.

Problems with thinking clearly, feeling drunk, a feeling of spinning, or nausea, vomiting, dizziness, drowsiness, tiredness, or reduced sense of touch may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• increased urination at night
• burning/pain when you urinate
• urgent or frequent urination

This medication may raise your blood pressure. An increase in blood pressure can last about 4 hours after a dose of esketamine. Your health care professional will check your blood pressure before and after your dose. Get medical help right away if you have any very serious side effects, including:

• chest pain
• shortness of breath
• sudden severe headache
• vision changes
• seizures
• loss of consciousness

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using esketamine, tell your doctor or pharmacist if you are allergic to it; or to ketamine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• blood vessel problems (such as aneurysm in the brain/chest/aorta/abdomen/arms/legs, arteriovenous malformation)
• bleeding/increased pressure in the brain
• high blood pressure (including a syndrome of high blood pressure with seizures, severe headache, and coma)
• heart disease
• stroke
• liver disease
• a certain mental/mood disorder (psychosis)
• personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol)

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until the next day after a good night's sleep and until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using esketamine. Esketamine may harm an unborn baby. Ask about reliable forms of birth control while using this medication. However, since untreated mental/mood problems (such as depression) can harm a pregnant woman and her unborn baby, do not stop using this medication unless directed by your doctor. Ask your doctor if a different medication would be right for you. If you become pregnant or think you may be pregnant, talk to your doctor right away about the risks and benefits of this medication.

This medication passes into breast milk and may harm a nursing infant. Breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Tell your doctor or pharmacist if you are using other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others. Sharing it is against the law.

Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor right away for a new dosing schedule. Do not double the dose to catch up.

Not applicable. This medication is given in a medical clinic or doctor's office and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.