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Full Prescribing Information  |  Med Guide/IFU

Full Prescribing Information

Med Guide/IFU

Important Safety Information

Patient Site

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Revuforj® (revumenib) Logo

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.

Safety

Safety and tolerability of a targeted therapy

The safety profile of Revuforj reflects exposure in 241 patients (207 adult and 34 pediatric patients) with R/R KMT2A-translocated acute leukemia or R/R susceptible NPM1m AML

  • Patients received a dose ≈160 mg in adults orally twice daily with a strong CYP3A4 inhibitor

  • Median duration of exposure to Revuforj was 2.5 months (range: <1–40 months)

Adverse reactions reported in ≥20% (any Grade) or ≥5% (Grade 3 or 4) in patients with R/R acute leukemia (N=241)

Treatment-emergent
adverse event (TEAE)

All
Grades
(%)

Grade
3 or 4
(%)

Gastrointestinal disorders

Nauseaa

48

5

Diarrheab

29

5

Constipation

20

0

Vascular disorders

Hemorrhage*c

48

10

Thrombosisd

11

6

Infections and infestations

Infection without identified pathogenee

46

30

Bacterial infectionf

27

18

Viral infectiong

23

6

Blood and lymphatic system disorders

Febrile neutropenia

37

35

Treatment-emergent
adverse event (TEAE)

All
Grades
(%)

Grade
3 or 4
(%)

Musculoskeletal and connective tissue disorders

Musculoskeletal painh

37

6

Investigations

Electrocardiogram
QT prolonged

36

17

Neoplasms benign, malignant, and unspecified (including cysts and polyps)

Differentiation syndrome*

25

12

General disorders and administration site conditions

Fatiguei

24

5

Edemaj

24

0

Metabolism and nutrition disorders

Decreased appetite

20

5

  • Includes the following fatal adverse reactions: differentiation syndrome (n=2); hemorrhage (n=2).

See complete definitions of grouped terms.

See less circle

Selected new or worsening laboratory abnormalities in patients with R/R acute leukemia

Laboratory
abnormality

Grades
1-4*
(%)

Grades
3-4
(%)

Phosphate increased

51

–

Aspartate aminotransferase increased

44

6

Alanine aminotransferase increased

40

8

Creatinine
increased

38

2

Potassium decreased

34

12

Parathyroid hormone, intact increased

34

–

Alkaline phosphatase increased

33

<1

Triglycerides increased

27

3

Phosphate decreased

25

–

Cholesterol increased

17

0

Calcium
corrected,
increased

15

0

The denominator used to calculate the rate varied from 139 to 240 based on the number of patients with a baseline value and at least 1 post baseline value.

AML=acute myeloid leukemia; AR=adverse reaction; CYP3A4=cytochrome P450 3A4; KMT2A=lysine methyltransferase 2A; NPM1m=mutant nucleophosmin 1; R/R=relapsed/refractory.

Differentiation syndrome, which can be fatal, has occurred with Revuforj

In the clinical trial of patients with R/R KMT2A-translocated acute leukemia or R/R NPM1m AML, differentiation syndrome occurred in 25% of patients (n=60/241)

  • Differentiation syndrome 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)

  • Treatment interruption was required for 7% of patients, and treatment was withdrawn for 1%

Symptoms of differentiation syndrome, including those seen in patients treated with Revuforj, include:

  • Fever

  • Dyspnea

  • Hypoxia

  • Peripheral edema

  • Pleuropericardial effusion

  • Acute renal failure

  • Rash

  • Hypotension

Advise patients and their caregivers to contact their healthcare team or go to the nearest hospital emergency room immediately if the patient develops any of these symptoms while taking Revuforj

Encourage your patients to download the Differentiation Syndrome Wallet Card

WALLET CARD

Reduce the white blood cell count to less than 25 Gi/L prior to starting Revuforj
 If differentiation syndrome is suspected, immediately initiate treatment with systemic corticosteroids for a minimum of 3 days and until resolution of signs and symptoms.

Treatment example:

Icon of an adult

Patients ≥40 kg:

dexamethasone 10 mg IV

every 12 hours

Icon of a child

Patients <40 kg:

dexamethasone 0.25 mg/kg/dose
IV every 12 hours

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 differentiation syndrome recurs after tapering corticosteroids.

Review Dose Modifications for how to manage differentiation syndrome and other adverse reactions.

AML=acute myeloid leukemia;
KMT2A=lysine methyltransferase 2A;
NPM1m=mutant nucleophosmin 1; R/R=relapsed/refractory.

Additional Warnings & Precautions

Icon of QTc interval

QTc interval prolongation and Torsades de Pointes

Revuforj can cause QTc interval prolongation and Torsades de Pointes

QTc interval prolongation was reported as an adverse reaction in 36% of patients (n=86/241) in the clinical trials

  • 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

  • One patient had a fatal outcome of cardiac arrest, and 1 patient had non-sustained Torsades de Pointes

Review the Monitoring Guidance for QTc prolongation and Torsades de Pointes.

Icon of QTc interval

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.

Verify pregnancy status in females of reproductive potential within 7 days prior to initiating Revuforj.

NEXT: DOSING & MANAGEMENT

Reference: Revuforj® [Prescribing Information]. Syndax Pharmaceuticals, Inc.; October 2025.

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


SPECIAL 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.