Initial US Approval:
2024
Key Clinical Studies:
SNDX-5613-0700, NCT04065399; AUGMENT-101
Drug Class/Description:
Menin inhibitor
Indications and Usage:
Treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.
Dosage Administration:
- Select patients for treatment with REVUFORJ based on the presence of a KMT2A translocation.
- 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:
QTc Interval Prolongation: Monitor electrocardiograms and electrolytes. Correct hypokalemia and hypomagnesemia prior to and during treatment. If QTc interval prolongation occurs, interrupt, reduce, or permanently discontinue REVUFORJ.
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 hemorrhage, nausea, phosphate increased, musculoskeletal pain, infection, aspartate aminotransferase increased, febrile neutropenia, alanine aminotransferase increased, parathyroid hormone intact increased, bacterial infection, diarrhea, differentiation syndrome, electrocardiogram QT prolonged, phosphate decreased, triglycerides increased, potassium decreased, decreased appetite, constipation, edema, viral infection, fatigue, and alkaline phosphatase increased.
Use in Specific Populations:
- Lactation: Advise not to breastfeed
Adapted from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218944s000lbl.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.
