Pronunciation: REV-you-forge
Generic name: revumenib
Dosage form: oral tablets (25 mg, 110 mg, 160 mg)
Drug class: Miscellaneous antineoplastics

Medically reviewed by Carmen Pope, BPharm. Last updated on Nov 20, 2024.

What is Revuforj?

Revuforj is used to treat acute leukemia with a lysine methyltransferase 2A gene translocation (KMT2A) in adults and children 1 year and older whose disease has come back or has not improved after previous treatment(s).

• Your healthcare provider will perform a test to make sure that Revuforj is right for you.

Revuforj’s mechanism of action involves blocking the interaction of both wild-type lysine methyltransferase 2A (KMT2A) and KMT2A fusion proteins with menin. KMT2A fusion protein rearrangements allow menin to drive cancer growth in KMT2A-rearranged (KMT2Ar) acute leukemias. Revuforj belongs to the drug class called menin inhibitors.

Revuforj gained FDA approval on 15 November 2024. There is no Revuforj generic available.

Revuforj side effects

The most common side effects of Revuforj are:

• bleeding (hemorrhage)
• changes in liver function tests
• nausea and vomiting
• muscle pain
• swelling in the arms and legs
• decreased appetite
• infections, including bacterial and viral infections
• constipation
• low white blood cell counts with fever
• tiredness
• diarrhea.

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with Revuforj if you develop certain side effects.

Revuforj may cause fertility problems in females and males. Talk to your healthcare provider if this is a concern for you.

Serious side effects and warnings

Revuforj carries a Boxed Warning for differentiation syndrome and can cause other serious side effects.

Differentiation syndrome is a serious, but common condition that affects your blood cells which may be life-threatening or lead to death if not treated. Differentiation syndrome has happened as early as 3 days and up to 41 days after starting Revuforj. Tell any healthcare provider caring for you that you are taking a medicine that can cause differentiation syndrome. Call your healthcare provider or go to the nearest hospital emergency room right away if you develop any of the following symptoms of differentiation syndrome during treatment with Revuforj:

• fever
• dizziness or lightheadedness
• cough
• fast weight gain
• shortness of breath
• swelling of arms, legs, neck, groin, or underarm area
• severe headache
• confusion
• decreased urination.

If you develop any of these symptoms of differentiation syndrome, your healthcare provider may start you on a medicine given through a vein (intravenous) called corticosteroids and may monitor you in the hospital.

Changes in the electrical activity of your heart called QT prolongation. QT prolongation is a serious, but common side effect that can cause irregular heartbeats that can be life-threatening or lead to death. Your healthcare provider will check your heart's electrical activity with an electrocardiogram (ECG) and do blood tests to check your potassium and magnesium levels before and during treatment with Revuforj. Tell your healthcare provider right away if you feel faint, lightheaded, dizzy, or if you feel your heart beating irregularly or fast during treatment with Revuforj.

It is not known if Revuforj is safe and effective in children less than 1 year of age.

These are not all possible side effects of Revuforj. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Before taking

Before taking Revuforj, tell your healthcare provider about all of your medical conditions, including if you:

• have any heart problems, including a condition called long QT syndrome
• have been told you have low blood levels of potassium or magnesium
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Revuforj can harm an unborn baby. Your healthcare provider will perform a pregnancy test within 7 days before you start treatment with Revuforj if you are a woman who can become pregnant. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Revuforj.

Females who can become pregnant should use effective birth control (contraception) during treatment with Revuforj and for 4 months after the last dose of Revuforj.

Males with female partners who can become pregnant should use effective birth control during treatment with Revuforj and for 4 months after the last dose of Revuforj.

Talk to your healthcare provider about birth control methods you can use during this time.

Breastfeeding

It is not known if Revuforj passes into your breast milk. Do not breastfeed during your treatment with Revuforj or for 1 week after your last dose of Revuforj.

How should I take Revuforj?

Take Revuforj exactly as your healthcare provider tells you to. Do not change your dose or stop taking Revuforj unless your healthcare provider tells you to.

Revuforj tablets come in different strengths. Each strength is a different color. Your healthcare provider may prescribe more than one strength of Revuforj tablets for you, so it is important that you understand how to take your medicine the right way. Be sure that you understand exactly how many tablets you need to take, and what strengths to take.

Take Revuforj 2 times a day at about the same time each day about 12 hours apart.

• Revuforj can be taken on an empty stomach or with a low-fat meal.
• Swallow Revuforj tablets whole with a cup of water. If you are unable to swallow Revuforj tablets see the instructions below.

Unable to swallow Revuforj tablets

1. If you are unable to swallow Revuforj tablets, crush the tablets with a clean and dry pill crusher until they are the consistency of flour.
2. Using a teaspoon, measure approximately 10 mL of room temperature water into a clean, dry, small container. One teaspoon usually holds around 5 mL.
3. Tip all the crushed Revuforj tablets into the water by tapping the container.
4. Swirl the container every 30 seconds for 1 minute. Repeat for a total of 5 minutes. The crushed tablets will look cloudy.
5. Using a 20 mL oral syringe, draw up all the contents of the container into the syringe. The medicine must be taken within 2 hours of preparation. Turn the oral syringe upside down and back several times before taking or giving the medicine.
6. The adult or child taking the medicine should sit or stand upright. Place the tip of the oral syringe into the mouth against the inside of the cheek. Slowly and gently press down on the plunger to gently squirt the medicine into the mouth. Allow the adult or child to swallow the medicine. Make sure that no medicine is left in the mouth.
7. Rinse the container with 10 mL of water and draw it up with the syringe, making sure no medicine is left behind. Squirt the contents inside the mouth and repeat this step until no medicine is left.
8. The adult or child receiving the medicine should remain sitting up straight or standing for 2 to 3 minutes right after receiving a dose of the medicine.
9. Clean the oral syringe and container used for mixing thoroughly.
10. See the Revuforj Medication Guide for more detailed information.

If the medicine is vomited or all of the medicine is not swallowed, do not give another dose. Wait until the next scheduled dose.

What happens if I miss a dose?

If you miss a dose of Revuforj or did not take it at the usual time, take your dose as soon as possible and at least 12 hours before your next dose. Do not take 2 doses within 12 hours. Return to your normal scheduled dose the following day.

What other drugs will affect Revuforj?

Tell your healthcare provider about any other medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Revuforj and other medicines may affect each other causing side effects. Especially tell your healthcare provider if you take:

• Strong CYP3A4 Inhibitors, such as clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal, and grapefruit. Your healthcare provider should reduce your Revuforj dose
• Strong or moderate CYP3A4 Inducers, such as phenobarbital, phenytoin and rifampicin. It is recommended that these are not used together with Revuforj
• QTc Prolonging Drugs, such as antipsychotics, antiarrhythmics, antidepressants, and antihistamines. It is recommended that these not be used together but if concomitant use is unavoidable, your healthcare provider should monitor you more frequently for QTc interval prolongation

Know the medicines you take. Keep a list to show your healthcare provider and pharmacist when you get a new medicine.

Storage

Store Revuforj at room temperature between 68°F to 77°F (20°C to 25°C).

Keep the tablets in the bottle it comes in until you are ready to take them. The Revuforj bottle has a drying agent (desiccant) and child-resistant closure.

Keep Revuforj and all medicines out of reach of children

Revuforj ingredients

Active ingredient: revumenib

Inactive ingredients: microcrystalline cellulose, dicalcium phosphate, crospovidone, hypromellose, sodium bicarbonate, hydrophobic colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and red iron oxide.

The 110 mg tablet also includes yellow iron oxide.

The 160 mg tablet also includes FD&C blue #2/indigo carmine aluminum lake.

Available as Revuforj 25 mg, 110 mg, and 160 mg tablets.

Who makes Revuforj?

Syndax Pharmaceuticals, Inc. manufactures Revuforj.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer