Prescription medicine
Revumenib Brand names: Revuforj
Revumenib (Revuforj) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the revumenib FDA label on DailyMed (effective February 4, 2026, Syndax Pharmaceuticals, Inc.); the NDA 218944 record on Drugs@FDA; every revumenib label on DailyMed.
Highlights of the record
FDA label of February 4, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
DIFFERENTIATION SYNDROME,.
QTc PROLONGATION and TORSADES DE POINTES Differentiation syndrome, which can be fatal, has occurred with REVUFORJ. Signs and symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and renal dysfunction. If differentiation syndrome is suspected, immediately initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution. [see Dosage and Administration (2.3 ), Warnings and Precautions (5.1), and Adverse Reactions (6.1) ]. QTc prolongation and Torsades de Pointes have occurred in patients receiving REVUFORJ. Correct hypokalemia and hypomagnesemia prior to and during treatment. Do not initiate REVUFORJ in patients with QTcF > 450 msec. If QTc interval prolongation occurs, interrupt, reduce, or permanently discontinue REVUFORJ. [see Dosage and Administration (2.3), Warnings and Precautions (5.2), and Adverse Reactions (6.1) ] WARNING: DIFFERENTIATION SYNDROME, and QTc PROLONGATION and TORSADES DE POINTES See full prescribing information for complete boxed warning. Differentiation syndrome, which can be fatal, has occurred with REVUFORJ. […]
Used for
From the label: indications and usageREVUFORJ is a menin inhibitor indicated for: the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older.
Forms and strengths
- 25 mg
- 110 mg
- 160 mg
Film-coated tablet.
On the market
- Earliest approval on file
- November 15, 2024 Revuforj, Syndax; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 18, 2042 Revuforj tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 878 through July 30, 2026
What is revumenib used for?
From the label: indications and usageREVUFORJ is a menin inhibitor indicated for: the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older. ( 1 ) the treatment of relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 ( NPM1 ) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options. […]
Conditions named in the indications of revumenib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Menin Inhibitor.
Source: FDA drug label (Revuforj), Syndax Pharmaceuticals, Inc., effective February 4, 2026 (SPL set 6eb3cdbc-0e74-477d-82d6-3bb172d3f63f), via openFDA; the full label on DailyMed
What does the patient leaflet for revumenib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about REVUFORJ?REVUFORJ may cause serious side effects including: differentiation syndrome. 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 cough shortness of breath severe headache confusion dizziness or lightheadedness fast weight gain swelling of arms, legs, neck, groin, or underarm area decreased urination rash 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 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, such as a heart attack, and can lead to death. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) and will also 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. See "What are the possible side effects of REVUFORJ?" for more information about side effects.
From the patient leaflet: How should I store REVUFORJ?Store REVUFORJ at room temperature between 68°F to 77°F (20°C to 25°C). Store the tablets in the bottle that it comes in until you are ready to take it. The REVUFORJ bottle has a drying agent (desiccant) and child resistant closure. Keep REVUFORJ and all medicines out of reach of children.
Source: FDA drug label (Revuforj), Syndax Pharmaceuticals, Inc., effective February 4, 2026 (SPL set 6eb3cdbc-0e74-477d-82d6-3bb172d3f63f), via openFDA; the full label on DailyMed
Is there a generic for revumenib (Revuforj)?
No generic revumenib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Revuforj tablets: the compound patent runs to June 8, 2037, and the last listed entry to December 18, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2042 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the revumenib label say about other medicines?
The revumenib label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Dexamethasone | warnings and precautions | If DS is suspected, immediately initiate treatment with systemic corticosteroids (e.g., dexamethasone 10 mg intravenously every 12 hours in adults or dexamethasone 0.25 mg/kg/dose intravenously every 12 hours in pediatric patients weighing less than 40 kg) for a minimum of 3 days and until resolution of signs and … |
Source: FDA drug label (Revuforj), Syndax Pharmaceuticals, Inc., effective February 4, 2026 (SPL set 6eb3cdbc-0e74-477d-82d6-3bb172d3f63f), via openFDA; the full label on DailyMed
What do FAERS reports show for revumenib?
The FDA Adverse Event Reporting System holds 878 reports that list revumenib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 123 are coded as a death and 266 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as revumenib?
37 other medicines are given the same way (oral) and in the same FDA class as revumenib or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ziftomenib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Lenalidomide | Leukemia, lymphoma and myeloma | 18 labelers | n/a | No current entry |
| Dasatinib | Leukemia, lymphoma and myeloma | 14 labelers | $26.46 per tablet 100 mg tablet | No current entry |
| Pomalidomide | Leukemia, lymphoma and myeloma | 11 labelers | n/a | No current entry |
| Imatinib | Leukemia, lymphoma and myeloma | 20 labelers | $0.624 per tablet 100 mg tablet | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | none listed | n/a | A presentation being discontinued |
| Nilotinib | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
| Hydroxyurea | Leukemia, lymphoma and myeloma | 10 labelers | $0.184 per capsule 500 mg capsule | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to revumenib
- 37 medicines for the same use
- Other menin inhibitors
- the pharmacologic class, with prices and generics
- Revumenib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other