Revumenib

Revumenib is used to treat a specific type of acute leukemia in adults and children who are at least 1 year old.

Revumenib is typically given after other treatments have failed or are no longer effective.

Your doctor will confirm that you have the right gene mutation to be treated with revumenib.

Revumenib may also be used for reasons not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time. Use the medicine exactly as directed.

Your treatment may require you to take more than one tablet and different doses of this medicine to get your full dose. Avoid medication errors by using it exactly as directed on the label, or as prescribed by your doctor.

Take twice a day, about 12 hours apart, on an empty stomach or with a low-fat meal (about 400 calories).

Swallow the tablet whole with a full glass of water.

If you cannot swallow the medicine, read and carefully follow the Instructions for Use provided to you on how to prepare and use revumenib. Ask a doctor or pharmacist if you do not understand these instructions.

If you vomit shortly after taking revumenib, do not take another dose. Take your next dose as scheduled.

Your heart function and blood will need to be tested before and during treatment. Your treatment may be adjusted based on the results.

Doses may be based on body surface area (height and weight) or weight only. Your dose may change if you gain or lose weight or if you are still growing.

You may receive other medications to help prevent serious side effects or an allergic reaction. Continue using these medicines for as long as your doctor has prescribed.

Store at room temperature, away from moisture and heat.

Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Revumenib can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 3 days to 41 days after you start taking revumenib.

Tell your medical caregivers if you have signs of differentiation syndrome: fever, dizziness, cough, trouble breathing, swelling, rapid weight gain, rash, or decreased urination.

Tell your doctor if you have or have ever had:

• heart problems;
• long QT syndrome; or
• an electrolyte imbalance (such as low blood levels of potassium or magnesium).

Revumenib can harm an unborn baby if the mother or the father is using revumenib.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 4 months after your last dose. Tell your doctor if you become pregnant.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 4 months after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

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

Revumenib can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 3 days to 41 days after you start taking revumenib. Seek medical help right away if you have symptoms of differentiation syndrome: fever, cough, trouble breathing, dizziness, rash, decreased urination, rapid weight gain, or swelling in your arms or legs.

Revumenib may cause serious side effects. Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest, and sudden dizziness (like you might pass out).

Your cancer treatments may be delayed, changed, or permanently discontinued if you have certain side effects.

Common side effects of revumenib may include:

• muscle pain, tiredness, loss of appetite;
• bleeding;
• bacterial or viral infections, low white blood cells, fever;
• abnormal blood tests;
• swelling in your arms and legs; or
• nausea, diarrhea, constipation, vomiting.

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.

Take the medicine as soon as you remember and at least 12 hours before your next dose. Return to your regular schedule the next day. Do not use two doses within 12 hours.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, drinks, or activities.

Sometimes it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.

Revumenib can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Other drugs may affect revumenib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you are using.