TM Owner Syndax Pharmaceuticals
Revuforj 25mg, 110mg or 160mg (no 50mg strength exists) Tablet (film-coated)
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Indications & Clinical Uses
- Revuforj (revumenib) tablets contain a first-in-class menin inhibitor.
- It was approved by the FDA (2024, expanded 2025) for two indications in patients aged 1 year and older with relapsed or refractory acute leukaemia who have no satisfactory alternative treatment: acute leukaemia with a KMT2A gene translocation, and acute myeloid leukaemia (AML) with a susceptible NPM1 mutation, each confirmed by an FDA-authorised companion diagnostic test.
- It works by blocking the menin-KMT2A protein interaction that drives abnormal blood cell growth in these leukaemia subtypes.
- Revuforj is supplied as 25mg, 110mg and 160mg film-coated tablets; dosing is individualised by body weight and by whether the patient is also taking a strong CYP3A4 inhibitor, and it is taken twice daily by mouth.
- This is a specialist haemato-oncology treatment, prescribed and closely monitored by a cancer specialist, though tablets are usually taken by the patient at home once the starting dose is established.
Side Effects
- Revuforj carries a boxed warning for two serious risks.
- Differentiation syndrome, which can be fatal, occurred in about a quarter of patients and causes fever, breathlessness, low oxygen, lung infiltrates and swelling; it needs immediate corticosteroid treatment and close monitoring, sometimes in hospital.
- Revumenib can also prolong the heart's QT interval and lead to torsades de pointes, a dangerous irregular heartbeat, so a baseline ECG and blood tests are required before starting and regularly during treatment.
- Very common side effects (affecting 1 in 5 or more patients) include low phosphate, bleeding, nausea, infections, raised liver enzymes, raised creatinine, muscle or bone pain, fever with low white cell count, low potassium, diarrhoea and tiredness.
- Tell your care team immediately about breathlessness, chest tightness, palpitations, fainting, unusual bleeding or bruising, or signs of infection such as fever.
Precautions & Warnings
- Revuforj must not be started until any electrolyte abnormalities (potassium, magnesium, calcium) are corrected, and should not be started if the baseline QT interval (QTcF) is above 450 milliseconds; your care team records an ECG at baseline, weekly for the first month, then monthly, and after any dose change.
- Watch for differentiation syndrome, which can appear within days or up to several months after starting; report new breathlessness, rapid weight gain, swelling or fever without delay, as this needs prompt corticosteroid treatment and may require withholding the dose.
- Revumenib can harm an unborn baby, so effective contraception is required during treatment and for 4 months afterward for patients and partners who could become pregnant; it should not be used during pregnancy or breastfeeding.
- Liver and kidney function are monitored during treatment, and your care team should be told before any live vaccine is given.
Avoid Interactions
- Revumenib is broken down mainly by the CYP3A4 liver enzyme, so strong CYP3A4 inhibitors (such as certain antifungals, some HIV medicines and clarithromycin) raise revumenib levels and require a lower Revuforj dose decided by your care team - never adjust the dose yourself.
- Strong or moderate CYP3A4 inducers, including rifampin, carbamazepine, phenytoin and St John's wort, lower revumenib levels and reduce its effect, so these should be avoided during treatment.
- Because Revuforj can prolong the QT interval, avoid other medicines that do the same, such as certain antibiotics, antiarrhythmics and antipsychotics, unless your care team says otherwise.
- Grapefruit and grapefruit juice can raise revumenib levels and should be avoided.
- Always tell your prescriber and pharmacist about every prescription, over-the-counter medicine, herbal product and supplement you take.
References
Frequently Asked Questions
Revuforj (revumenib) is a menin inhibitor tablet used for relapsed or refractory acute leukaemia with a KMT2A gene translocation, or AML with an NPM1 mutation, in patients 1 year and older with no other good treatment option. A companion diagnostic test confirms eligibility before starting.
Revuforj is taken by mouth twice daily as 25mg, 110mg or 160mg film-coated tablets, with the dose set by your body weight and by whether you're also taking a strong CYP3A4 inhibitor. A cancer specialist decides and adjusts your exact dose.
Revuforj carries a boxed warning for differentiation syndrome, which can be fatal and causes fever, breathlessness and swelling, and for QT prolongation, a heart rhythm change. Very common effects include low phosphate, bleeding, nausea, infection, raised liver enzymes and tiredness. Report breathlessness or palpitations immediately.
Avoid grapefruit, strong CYP3A4 inhibitors and inducers (such as certain antifungals, rifampin or St John's wort), and other QT-prolonging medicines unless your care team approves them. Revumenib can harm an unborn baby, so use effective contraception during treatment and for 4 months after the last dose.
Your care team checks an ECG and blood electrolytes before starting Revuforj, weekly for the first 4 weeks, then monthly, because revumenib can prolong the QT interval. Liver function and blood counts are also monitored regularly, and doses may be adjusted or paused based on the results.
Yes. Revuforj is approved for both adults and children aged 1 year and older with the qualifying leukaemia and confirmed gene mutation. Dosing in children is based on body weight, and the same monitoring for differentiation syndrome and QT prolongation applies regardless of age.
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