Revumenib (Oral)
Revumenib is used to treat a certain type of acute leukemia in adults and children at least 1 years old.
Revumenib is usually given after other treatments did not work or stopped working.
Your doctor will make sure you have the correct gene mutation to be treated with revumenib.
Revumenib may also be used for purposes not listed in this medication guide.
warnings
What is the most important information I should know about Revumenib (Oral)?
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 this medicine.
- 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.
Side Effects
What are the side effects of Revumenib (Oral)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult 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.
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 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.
Pregnancy & Breastfeeding
Can I take Revumenib (Oral) if I’m pregnant or breastfeeding?
Do not breastfeed while using this medicine, and for at least 1 week after your last dose.
Interactions
What drugs and food should I avoid while taking Revumenib (Oral)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
How to take Revumenib (Oral)?
Use Revumenib (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Your treatment may require you to use more than one tablet and different doses of this medicine to receive your full dose. Avoid medication errors by using exactly as directed on the label, or as prescribed by your doctor.
Take twice per 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 are unable to 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 changed 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 be given other medications to help prevent serious side effects or an allergic reaction. Keep 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.
Take the medicine as soon as you remember and at least 12 hours before your next dose. Return back your regular schedule the following day. Do not use two doses within 12 hours.
Overdose Signs
What happens if I overdose on Revumenib (Oral)?
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