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Full Prescribing Information

Full Prescribing Information

Important Safety Information

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Revuforj® (revumenib) Logo

For the treatment of adult and pediatric patients 1 year and older with:

  • R/R acute leukemia with a KMT2A translocation as determined by an FDA-authorized test
  • R/R AML with a susceptible NPM1 mutation who have no satisfactory alternative treatment options

Mechanism of Action

A first-in-class, oral, selective menin inhibitor1-4

Revuforj has the power to target and disrupt menin-KMT2A protein interactions—a key driver of NPM1-mutated AML and acute leukemias with a KMT2A translocation1,2,5-7

Menin interactions with wild-type KMT2A or KMT2A fusion proteins activate a leukemogenic transcriptional pathway1,2,5,7:

Revuforj inhibits menin-KMT2A interactions by binding to menin and blocking interactions with wild-type KMT2A and KMT2A fusion proteins1,2,5-7:

MOD Menin-KMT2A Interactions Revuforj® (revumenib) MOA Targets

Menin interacts with
wild-type KMT2A or
KMT2A fusion proteins

Binds to menin and
blocks interactions with
KMT2A proteins

MOD HOX/MEIS1 Increase Revuforj® (revumenib) MOA HOX/MEIS1 Decrease

Upregulates
HOX/MEIS1
gene expression

Downregulates
HOX/MEIS1
gene expression

MOD Differentiation Block Revuforj® (revumenib) MOA Block Released

Increases
proliferation of
undifferentiated cells

Releases the
differentiation block

MOD Leukemogenesis Revuforj® (revumenib) MOA Normal Cellular Differentiation

Results in acute
leukemia

Promotes normal
cellular differentiation

A first-in-class, oral, selective menin inhibitor1-4

Revuforj has the power to target and disrupt KMT2A protein interactions—a key driver of NPM1-mutated AML and acute leukemias with a KMT2A translocation1,2,5-7

Menin interactions with wild-type KMT2A or KMT2A fusion proteins activate a leukemogenic transcriptional pathway1,2,5,7::

Menin interacts with wild-type KMT2A

Menin interacts with
wild-type KMT2A or
KMT2A fusion proteins

Upregulates HOX/MEIS1 Increase

Upregulates
HOX/MEIS1
gene expression

MOD Differentiation Block

Increases
proliferation of
undifferentiated cells

MOD Leukemogenesis

Results in acute
leukemia

Revuforj logo

Revuforj inhibits menin-KMT2A interactions by binding to menin and blocking interactions with wild-type KMT2A and KMT2A fusion proteins1,2,5-7:

Revuforj® (revumenib) MOA Targets

Binds to menin and
blocks interactions
with KMT2A proteins

Downregulates HOX/MEIS1 gene expression

Downregulates
HOX/MEIS1
gene expression

Revuforj® (revumenib) MOA Block Released

Releases the
differentiation block

Revuforj® (revumenib) MOA Normal Cellular Differentiation

Promotes normal
cellular differentiation

In nonclinical in vitro and in vivo studies, revumenib demonstrated anti-proliferative and anti-tumor activity in leukemia cells harboring KMT2A fusion proteins. Revumenib also showed anti-proliferative
activity in vitro in leukemia cells with an NPM1 mutation1

See the first FDA-approved menin inhibitor in action

Take a closer look at the disruption of menin-KMT2A interactions in KMT2A-translocated acute leukemia:

Video Thumbnail
The power to target multiple types of acute leukemia1

Revuforj is the first and only menin inhibitor with two FDA-approved indications
in both adult and pediatric patients 1 year and older with:

  • R/R KMT2A-translocated acute leukemia as determined by an FDA-authorized test

  • R/R susceptible* NPM1m AML who have no satisfactory alternative treatment options

NEXT: R/R NPM1m AML

Susceptible NPM1 mutations are defined as those that result in loss of the nucleolar localization signal and the insertion of a new nuclear export signal leading to the accumulation of mutant NPM1 in the cytoplasm of AML cells.1

AML=acute myeloid leukemia; HOX=homeobox; KMT2A=lysine methyltransferase 2A; MEIS1=MEIS homeobox-1; NPM1=nucleophosmin 1; R/R=relapsed/
refractory.

References: 1. Revuforj® [Prescribing Information]. Syndax Pharmaceuticals, Inc.; October 2025. 2. Arellano ML, et al. Blood. 2025;146(9):1065-1077. 3. Candoni A, Coppola G. Hematol Rep. 2024;16(2):244-254. 4. Center for Drug Evaluation and Research. NDA Multidisciplinary Review and Evaluation for Application 218944. November 15, 2024. 5. Uckelmann HJ, et al. Cancer Discov. 2023;13(3):746-765. 6. Issa GC, et al. J Clin Oncol. 2025;43(1):75-84. 7. Issa GC, et al. Leukemia. 2021;35:2482-2495.

IMPORTANT SAFETY
INFORMATION AND
INDICATIONS

WARNING: 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.
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.

WARNINGS AND PRECAUTIONS

Differentiation Syndrome: Revuforj can cause fatal or life-threatening differentiation syndrome (DS). Symptoms of DS, including those seen in patients treated with Revuforj, include fever, dyspnea, hypoxia, peripheral edema, pleuropericardial effusion, acute renal failure, rash, and/or hypotension.


In clinical trials, DS occurred in 60 (25%) of 241 patients treated with Revuforj at the recommended dosage for relapsed or refractory acute leukemia. Among those with a KMT2A translocation, DS occurred in 33% of patients with acute myeloid leukemia (AML), 33% of patients with mixed-phenotype acute leukemia (MPAL), and 9% of patients with acute lymphoblastic leukemia (ALL); DS occurred in 18% of patients with NPM1m AML. DS was Grade 3 or 4 in 12% of patients and fatal in 2 patients. The median time to initial onset was 9 days (range 3-41 days). Some patients experienced more than 1 DS event. Treatment interruption was required for 7% of patients, and treatment was withdrawn for 1%.


Reduce the white blood cell count to less than 25 Gi/L prior to starting Revuforj. If DS is suspected, immediately initiate treatment with systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours in adults or dexamethasone 0.25 mg/kg/dose IV every 12 hours in pediatric patients weighing less than 40 kg) for a minimum of 3 days and until resolution of signs and symptoms. Institute supportive measures and hemodynamic monitoring until improvement. Interrupt Revuforj if severe signs and/or symptoms persist for more than 48 hours after initiation of systemic corticosteroids, or earlier if life-threatening symptoms occur such as pulmonary symptoms requiring ventilator support. Restart steroids promptly if DS recurs after tapering corticosteroids.


QTc Interval Prolongation and Torsades de Pointes: Revuforj can cause QT (QTc) interval prolongation and Torsades de Pointes.


Of the 241 patients treated with Revuforj at the recommended dosage for relapsed or refractory acute leukemia in clinical trials, QTc interval prolongation was reported as an adverse reaction in 86 (36%) patients. QTc interval prolongation was Grade 3 in 15% and Grade 4 in 2%. The heart-rate corrected QT interval (using Fridericia’s method) (QTcF) was greater than 500 msec in 10%, and the increase from baseline QTcF was greater than 60 msec in 24%. Revuforj dose reduction was required for 7% due to QTc interval prolongation. QTc prolongation occurred in 21% of the 34 patients less than 17 years old, 35% of the 146 patients 17 years to less than 65 years old, and 46% of the 61 patients 65 years or older. One patient had a fatal outcome of cardiac arrest, and one patient had non-sustained Torsades de Pointes.


Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to and throughout treatment with Revuforj. Perform an electrocardiogram (ECG) prior to initiation of Revuforj, and do not initiate Revuforj in patients with QTcF >450 msec. Perform an ECG at least once weekly for the first 4 weeks and at least monthly thereafter. In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent ECG monitoring may be necessary. Concomitant use with drugs known to prolong the QTc interval may increase the risk of QTc interval prolongation.


  • Interrupt Revuforj if QTcF increases >480 msec and <500 msec, and restart Revuforj at the same dose twice daily after the QTcF interval returns to ≤480 msec
  • Interrupt Revuforj if QTcF increases >500 msec or by >60 msec from baseline, and restart Revuforj twice daily at the lower dose level after the QTcF interval returns to ≤480 msec
  • Permanently discontinue Revuforj in patients with ventricular arrhythmias and in those who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia

Embryo-Fetal Toxicity: Revuforj can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with Revuforj and for 4 months after the last dose of Revuforj.


ADVERSE REACTIONS

Fatal adverse reactions occurred in 9 (4%) patients who received Revuforj, including 4 with sudden death, 2 with differentiation syndrome, 2 with hemorrhage, and 1 with cardiac arrest.


Serious adverse reactions were reported in 184 (76%) patients. The most frequent serious adverse reactions (≥10%) were infection (29%), febrile neutropenia (20%), bacterial infection (15%), differentiation syndrome (13%), and hemorrhage (11%).


The most common adverse reactions (≥20%) including laboratory abnormalities, were phosphate increased (51%), hemorrhage (48%), nausea (48%), infection without identified pathogen (46%), aspartate aminotransferase increased (44%), alanine aminotransferase increased (40%), creatinine increased (38%), musculoskeletal pain (37%), febrile neutropenia (37%), electrocardiogram QT prolonged (36%), potassium decreased (34%), parathyroid hormone intact increased (34%), alkaline phosphatase increased (33%), diarrhea (29%), bacterial infection (27%), triglycerides increased (27%), phosphate decreased (25%), differentiation syndrome (25%), fatigue (24%), edema (24%), viral infection (23%), decreased appetite (20%), and constipation (20%).


DRUG INTERACTIONS

Drug interactions can occur when Revuforj is concomitantly used with:

  • Strong CYP3A4 inhibitors: reduce Revuforj dose

  • Strong or moderate CYP3A4 inducers: avoid concomitant use with Revuforj

  • QTc-prolonging drugs: avoid concomitant use with Revuforj. If concomitant use is unavoidable, obtain ECGs when initiating, during concomitant use, and as clinically indicated. Withhold Revuforj if the QTc interval is >480 msec. Restart Revuforj after the QTc interval returns to ≤480 msec


SPECIFIC POPULATIONS

Lactation: advise lactating women not to breastfeed during treatment with Revuforj and for 1 week after the last dose.

Pregnancy and Testing: Revuforj can cause fetal harm when administered to a pregnant woman. Verify pregnancy status in females of reproductive potential within 7 days prior to initiating Revuforj.

Infertility: based on findings in animals, Revuforj may impair fertility. The effects on fertility were reversible.

Pediatric: monitor bone growth and development in pediatric patients.

Geriatric: no overall differences were observed in the effectiveness of Revuforj between patients who were 65 years and older, and younger patients. Compared to younger patients, the incidences of QTc prolongation and edema were higher in patients 65 years and older.


To report SUSPECTED ADVERSE REACTIONS, contact Syndax Pharmaceuticals at 1-888-539-3REV or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


INDICATIONS

Revuforj® (revumenib) is a menin inhibitor indicated for the treatment of:

  • relapsed or refractory (R/R) 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

  • 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


Please see Full Prescribing Information, including BOXED WARNINGS.

IMPORTANT SAFETY
INFORMATION AND
INDICATIONS

IMPORTANT SAFETY
INFORMATION AND
INDICATIONS

WARNING: 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.