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Patients selected for revumenib treatment must have confirmed KMT2A translocation or NPM1 mutation.
Administer orally twice daily, either on an empty stomach or with a low-fat meal, at approximately the same times each day. The specific dosage is determined based on the patient’s body weight and concurrent use of potent CYP3A4 inhibitors.
For patients with a body weight of 40 kg or more:
Without concurrent use of potent CYP3A4 inhibitors: The recommended dosage is 270 mg twice daily.
With concurrent use of potent CYP3A4 inhibitors: Adjust the dosage to 160 mg twice daily.
For patients with a body weight less than 40 kg:
Dosage is calculated based on body surface area (BSA).
Without concurrent use of potent CYP3A4 inhibitors: The recommended dosage is 160 mg/m² twice daily.
With concurrent use of potent CYP3A4 inhibitors: Adjust the dosage to 95 mg/m² twice daily.
A detailed dosage table corresponding to body surface area is provided in the document. For example, for a patient with a BSA of 1.4 m², the corresponding dosages are 220 mg (based on 160 mg/m²) and 135 mg (based on 95 mg/m²), with equivalent dosages specified for other BSA values.
Prior to initiating revumenib treatment, reduce the white blood cell count to below 25 Gi/L. Continue treatment until disease progression or unacceptable toxicity occurs. For patients without disease progression or unacceptable toxicity, treatment should be administered for at least 6 months to evaluate clinical response.
Correct hypokalemia, hypomagnesemia, and other electrolyte abnormalities before treatment initiation.
Administer orally at approximately the same times each day.
Instruct patients to swallow the tablets whole; do not split or chew the tablets. If a patient is unable to swallow the tablet whole, crush the tablet and disperse it in water, then administer the mixture within 2 hours of preparation.
If a dose is missed or not taken at the regular time, administer the missed dose as soon as possible on the same day, at least 12 hours before the next scheduled dose. Resume the regular dosing schedule the following day. Do not take 2 doses within a 12-hour period.
Assess blood cell counts, electrolytes, and liver enzymes monthly before and after initiating revumenib treatment. Perform electrocardiograms (ECG) before treatment, at least once weekly during the first 4 weeks of treatment, and at least once monthly thereafter. Monitor for QTc interval prolongation and manage any abnormalities promptly.
Interrupt dosing, reduce dosage, or discontinue treatment permanently based on the type and severity of adverse reactions. The document provides detailed management strategies and dosage adjustment guidelines for specific adverse reactions, including differentiation syndrome, non-infectious leukocytosis, QTc interval prolongation, electrolyte abnormalities, other non-hematologic adverse reactions, neutropenia or thrombocytopenia, and hypersensitivity reactions.
Dosage reduction levels are also specified according to the patient’s body weight and concurrent use of potent CYP3A4 inhibitors. For example, for patients with a body weight of 40 kg or more who are not using potent CYP3A4 inhibitors and are on an initial dosage of 270 mg twice daily, the reduced dosage is 160 mg twice daily.
FDA，2025.10
