Revumenib (Revuforj) is a novel menin inhibitor developed by Syndax Pharmaceuticals. It was first approved in the United States in 2024.
Indications of Revumenib (Revuforj)
Relapsed or Refractory Acute Leukemia with KMT2A Gene Translocation
It is indicated for the treatment of relapsed or refractory acute leukemia with KMT2A gene translocation in adult patients and pediatric patients aged 1 year and older.
Patient Selection Criteria
The presence of KMT2A gene translocation must be confirmed by testing before treatment.
Currently, there is no FDA-approved companion diagnostic test available.
Before initiating treatment, it is necessary to ensure that the white blood cell (WBC) count is reduced to below 25 Gi/L.
Dosage Form, Strength and Characteristics of Revumenib (Revuforj)
Dosage Form and Strength
25 mg tablets: Pink modified oval film-coated tablets, imprinted with "S" on one side and "25" on the other side.
110 mg tablets: Beige modified oval film-coated tablets, imprinted with "S" on one side and "110" on the other side.
160 mg tablets: Purple modified oval film-coated tablets, imprinted with "S" on one side and "160" on the other side.
Active Ingredient
Each tablet contains revumenib citrate hydrate.
Molecular formula: C₃₂H₄₇FN₆O₄S●C₆H₈O₇●H₂O.
Molecular weight: 840.96 g/mol
Excipients
25 mg tablets: Microcrystalline cellulose, dicalcium phosphate, etc.
110 mg tablets: Additional yellow iron oxide.
160 mg tablets: Additional FD&C Blue No. 2/Indigo Carmine Aluminum Lake.
Storage Method of Revumenib (Revuforj)
Temperature Requirements
Recommended storage temperature: 20°C to 25°C (68°F to 77°F).
Short-term storage at 15°C to 30°C (59°F to 86°F) is permitted.
Packaging Requirements
Must be stored in the original bottle until dispensed and used.
Keep the desiccant inside the bottle intact.
Store in a safe place out of the reach of children.
Special Precautions
Tablets should be kept intact and must not be split or chewed.
If the whole tablet cannot be swallowed, it can be crushed and dispersed in water, but the prepared mixture must be taken within 2 hours.
Expired drugs should be disposed of in accordance with medical waste regulations.
