Initial US Approval:
2024
Key Clinical Studies:
SNDX-5613-0700/AUGMENT-101 (NCT04065399)
Drug Class/Description:
Menin inhibitor
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. 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.
Indications and Usage:
REVUFORJ 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.
- 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.
Dosage and Administration:
- Select patients for treatment with REVUFORJ based on the presence of a KMT2A translocation or an NPM1 mutation.
- Administer REVUFORJ orally twice daily fasted or with a low-fat meal at approximately the same time each day.
- See Full Prescribing Information for recommended REVUFORJ dosage regimen, dosage modifications, and administration instructions.
Dosage Forms and Strengths:
Tablets: 25 mg, 110 mg, 160 mg
Contraindications:
None.
Warnings and Precautions:
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of potential risk to a fetus and to use effective contraception.
Adverse Reactions:
The most common adverse reactions (≥ 20%) including laboratory abnormalities, are 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.
Drug Interactions:
- Strong CYP3A4 Inhibitors: Reduce the 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, monitor patients more frequently for QTc interval prolongation.
Use in Specific Populations:
Lactation: Advise not to breastfeed.
Adapted From:
https://cms.syndax.com/wp-content/uploads/Revuforj-full-prescribing-info.pdf
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
