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Full Prescribing Information  |  Med Guide/IFU

Full Prescribing Information

Med Guide/IFU

Important Safety Information

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Revuforj® (revumenib) Logo

Revuforj is a menin inhibitor indicated for the treatment of relapsed or refractory acute leukemia with a
lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.

Access &
Patient Support

Getting your patients started on Revuforj

Find the product information you need to order and access Revuforj

Revuforj
film-coated tablets

Revuforj
film-coated tablets

Revuforj
film-coated tablets

Dosage
strength

Dosage
strength

Dosage
strength

Description

Description

Description

National Drug Code
(NDC)

National Drug Code
(NDC)

National Drug Code
(NDC)

Revuforj® (revumenib) 110-mg Tablet

Tablet shown is
not actual size.

110 mg

Beige oval tablet debossed
with “S” on one side and
“110” on the other side

10-digit code:
73555-501-00
11-digit code:
73555-0501-00

Revuforj® (revumenib) 160-mg Tablet

Tablet shown
is not actual size.

160 mg

Purple oval tablet
debossed with “S” on one
side and “160” on the
other side

10-digit code:
73555-502-00
11-digit code:
73555-0502-00

Revuforj® (revumenib) 25-mg Tablet

Tablet shown is
not actual size.

25 mg

Pink modified oval film-
coated tablet debossed
with “S” on one side and
“25” on the other side

10-digit code: NDC
73555-500-00
11-digit code: NDC
73555-0500-00

The red zero converts the 10-digit NDC to the 11-digit NDC. Some payers may require each NDC to be listed on the claim. Payer requirements regarding the use of NDCs may vary. Electronic data exchange generally requires use of the 11-digit NDC.

How supplied/storage and handling

  • Each tablet strength packaged as 30-count
    bottles with a desiccant and child-resistant
    closure

  • Store at 20°C to 25°C (68°F to 77°F); excursions
    permitted between 15°C to 30°C (59°F to 86°F)

Revuforj® (revumenib) Bottles With Tablets

Bottles and tablets shown are not actual size.

Distribution Information

Revuforj is only available through the following specialty distributors and network specialty pharmacies

Revuforj is available through specialty distributors for shipment directly to office- or hospital-based pharmacies

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ASD Healthcare

1-800-746-6273
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Cardinal Health

1-855-855-0706
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McKesson

1-800-482-6700
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McKesson Plasma & Biologics

1-877-625-2566
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Oncology Supply

1-800-633-7555

Revuforj ships directly from the specialty pharmacy to your patient’s home or preferred location

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Onco 360

1-877-662-6633
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Biologics

1-800-850-4306

DISTRIBUTION FACT SHEET

Support throughout the treatment journey

Learn more about the SyndAccessTM Patient Support Program and how your patients may be eligible to pay as little as $0 copay per prescription.*

SyndAccess.com/hcp 1-888-567-SYND (7963)

Monday–Friday, 9 AM–6 PM ET

*Eligibility restrictions apply.

ENROLL YOUR PATIENTS

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IMPORTANT SAFETY
INFORMATION AND INDICATION

WARNING: DIFFERENTIATION SYNDROME

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.

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, and/or hypotension. In clinical trials, DS occurred in 39 (29%) of 135 patients treated with Revuforj. DS was Grade 3 or 4 in 13% of patients and fatal in one. The median time to onset was 10 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: In the clinical trials, QTc interval prolongation was reported as an adverse reaction in 39 (29%) of 135 patients treated with Revuforj. QTc interval prolongation was Grade 3 in 12% of patients. The heart-rate corrected QT interval (using Fridericia’s method) (QTcF) was greater than 500 msec in 8%, and the increase from baseline QTcF was greater than 60 msec in 18%. Revuforj dose reduction was required for 5% of patients due to QTc interval prolongation. QTc prolongation occurred in 16% of the 31 patients less than 17 years old, 33% of the 88 patients 17 years to less than 65 years old, and in 50% of the 16 patients 65 years or older.


Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to 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 4 (3%) patients who received Revuforj, including 2 with differentiation syndrome, 1 with hemorrhage, and 1 with sudden death.


Serious adverse reactions were reported in 99 (73%) patients. The most frequent serious adverse reactions (≥5%) were infection (24%), febrile neutropenia (19%), bacterial infection (17%), differentiation syndrome (12%), hemorrhage (9%), and thrombosis (5%).


The most common adverse reactions (≥20%) including laboratory abnormalities, were hemorrhage (53%), nausea (51%), phosphate increased (50%), musculoskeletal pain (42%), infection (41%), aspartate aminotransferase increased (37%), febrile neutropenia (35%), alanine aminotransferase increased (33%), parathyroid hormone intact increased (33%), bacterial infection (31%), diarrhea (30%), differentiation syndrome (29%), electrocardiogram QT prolonged (29%), phosphate decreased (25%), triglycerides increased (25%), potassium decreased (24%), decreased appetite (24%), constipation (23%), edema (23%), viral infection (23%), fatigue (22%), and alkaline phosphatase increased (21%).


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.


Pediatric: monitor bone growth and development in pediatric patients.


Geriatric: compared to younger patients, the incidences of QTc prolongation and edema were higher in patients 65 years and older.


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


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.


INDICATION

Revuforj® (revumenib) is a menin inhibitor indicated for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.


Please see Full Prescribing Information, including BOXED WARNING.

IMPORTANT SAFETY
INFORMATION AND INDICATION

IMPORTANT SAFETY
INFORMATION AND INDICATION

WARNING: DIFFERENTIATION SYNDROME

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.