Brand Name
Revuforj
Generic Name
Revumenib
View Brand Information FDA approval date: November 15, 2024
Form: Tablet
What is Revuforj (Revumenib)?
REVUFORJ is a menin inhibitor indicated for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene translocation in adult and pediatric patients 1 year and older. Relapsed or Refractory Acute Leukemia REVUFORJ is indicated for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene translocation in adult and pediatric patients 1 year and older.
Approved To Treat
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Brand Information
Revuforj (revumenib)
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. [see .
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.
1CONTRAINDICATIONS
None.
2ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Differentiation Syndrome
- QTc Interval Prolongation and Torsades de Pointes
2.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of REVUFORJ reflects exposure in 241 patients (207 adult and 34 pediatric patients) with relapsed or refractory (R/R) acute leukemia with a
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%).
Adverse reactions leading to dose interruption occurred in 49% of patients. The most common adverse reactions (≥ 5%) leading to dose interruption were electrocardiogram QT prolonged, infection, febrile neutropenia, differentiation syndrome, nausea, and hypokalemia. Adverse reactions leading to dose reduction occurred in 12% of patients who received REVUFORJ. Adverse reactions leading to a dose reduction (≥ 5%) included electrocardiogram QT prolonged. Adverse reactions leading to permanent discontinuation occurred in 20% of patients. Adverse reactions resulting in permanent discontinuation (> 1%) included infection.
The most common (≥ 20%) adverse reactions were phosphate increased, hemorrhage, nausea, infection without identified pathogen, aspartate aminotransferase increased, alanine aminotransferase increased, creatinine increased, musculoskeletal pain, febrile neutropenia, electrocardiogram QT prolonged, potassium decreased, parathyroid hormone intact increased, alkaline phosphatase increased, diarrhea, bacterial infection, triglycerides increased, differentiation syndrome, fatigue, edema, viral infection, phosphate decreased, decreased appetite, and constipation.
The common adverse reactions are summarised in Table 7.
Clinically relevant adverse reactions in less than 20% of patients who received REVUFORJ include:
Cardiac disorders: Premature ventricular complex, cardiac failure, pericardial effusion, ventricular tachycardia, cardiac arrest
Endocrine disorders: Hyperparathyroidism
Eye disorders: Cataract
Gastrointestinal disorders: Abdominal pain
General disorders and administration site conditions: Sudden death
Immune system disorders: Drug hypersensitivity
Metabolism and nutrition disorders: Hyponatremia, hyperkalemia
Nervous system disorders: Taste disorder, syncope, headache, paresthesia
Renal disorders: Renal impairment
Skin and subcutaneous disorders: Rash
Changes in selected post-baseline laboratory values that were observed in patients with relapsed or refractory acute leukemia are shown in Table 8.
3DESCRIPTION
REVUFORJ contains revumenib, a menin inhibitor. Revumenib is present as revumenib citrate hydrate with a chemical name of benzamide,
Revumenib citrate hydrate is a white to faint pink solid. Revumenib citrate hydrate is soluble at pH 1.2 and 6.8, and sparingly soluble at pH 4.5.
The chemical structure is shown in Figure 1.
Figure 1: Chemical structure of Revumenib Citrate
REVUFORJ is available as tablets for oral use.
Each 25 mg strength tablet contains 25 mg revumenib, equivalent to 33.4 mg revumenib citrate, and the following inactive ingredients: microcrystalline cellulose, dicalcium phosphate, crospovidone, hypromellose, sodium bicarbonate, hydrophobic colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and red iron oxide.
Each 110 mg strength tablet contains 110 mg revumenib, equivalent to 146.5 mg revumenib citrate, and the following inactive ingredients: microcrystalline cellulose, dicalcium phosphate, crospovidone, hypromellose, sodium bicarbonate, hydrophobic colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, red iron oxide, and yellow iron oxide.
Each 160 mg strength tablet contains 160 mg revumenib equivalent to 213.2 mg revumenib citrate, and the following inactive ingredients: microcrystalline cellulose, dicalcium phosphate, crospovidone, hypromellose, sodium bicarbonate, hydrophobic colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, red iron oxide, and FD&C blue #2/indigo carmine aluminum lake.
4PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide) and Instructions for Use.
5Revuforj 25 mg carton/container labels
Principle Display Panel
30 tablets
Revuforj®
(revumenib) tablets
(revumenib) tablets
25 mg
Dispense enclosed Medication Guide to each patient.
Swallow tablets whole or crush and disperse in water.
Syndax Rx Only
This bottle contains 30 tablets (25 mg each) of Revuforj®
revumenib. Swallow tablets whole or crush and (revumenib) tablets Keep out of
6Revuforj 110 mg carton/container labels
Principle Display Panel
30 tablets
Revuforj®
(revumenib) tablets
(revumenib) tablets
110 mg
Dispense enclosed Medication Guide
to each patient.
to each patient.
Swallow tablets whole or crush and
Syndax Rx Only
This bottle contains 30 tablets
(110 mg each) of revumenib. 30 tablets
Swallow tablets whole or crush
Store at 20°C to 25°C (68°F to 77°F); (revumenib) tablets
Recommended dosage:
Keep out of the reach of children.
Manufactured for: Syndax Rx Only
Syndax Pharmaceuticals, Inc.
Syndax Pharmaceuticals, Inc.
7Revuforj 160 mg carton/container labels
Principle Display Panel
30 tablets
Revuforj®
(revumenib) tablets
(revumenib) tablets
160 mg
Dispense enclosed Medication Guide
to each patient.
to each patient.
Swallow tablets whole or crush and
Syndax Rx Only
This bottle contains 30 tablets
(160 mg each) of revumenib. 30 tablets
Swallow tablets whole or crush
Store at 20°C to 25°C (68°F to 77°F); (revumenib) tablets
Recommended dosage:
Keep out of the reach of children.
Manufactured for: Syndax Rx Only
Syndax Pharmaceuticals, Inc.
Syndax Pharmaceuticals, Inc.