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Revumenib can induce fatal or life-threatening differentiation syndrome. Symptoms include fever, dyspnea, hypoxia, peripheral edema, pleuropericardial effusion, acute renal failure, rash, and/or hypotension. In clinical trials, differentiation syndrome occurred in approximately 25% of patients, among whom 12% were grade 3 or 4 cases, with 2 reported deaths. The median time to onset was 9 days.
Prior to initiating revumenib treatment, the white blood cell count must be reduced to below 25 Gi/L. If differentiation syndrome is suspected, systemic corticosteroid therapy should be immediately initiated (for at least 3 days until symptom resolution), along with hemodynamic monitoring and supportive care. If severe symptoms persist for more than 48 hours after the start of corticosteroid therapy, or life-threatening symptoms develop, revumenib treatment must be interrupted.
Revumenib can cause QTc interval prolongation and torsades de pointes. In clinical trials, QTc interval prolongation was reported as an adverse reaction in approximately 36% of patients, among whom 17% were grade 3 or 4 cases.
Electrolyte abnormalities (hypokalemia, hypomagnesemia) must be corrected before and during treatment. An electrocardiogram (ECG) should be performed prior to treatment; patients with a QTcF greater than 450 milliseconds should not start treatment. ECG monitoring should be conducted regularly during treatment.
If QTcF increases to greater than 480 milliseconds but less than 500 milliseconds, treatment should be interrupted and may be resumed at the original dose after correction of the abnormality.
If QTcF increases to greater than 500 milliseconds or by more than 60 milliseconds from baseline, treatment should be interrupted and resumed at a reduced dose after correction.
Permanent discontinuation of revumenib is required if ventricular arrhythmia occurs or QTc prolongation is accompanied by symptoms of life-threatening arrhythmia.
Based on findings from animal studies and its mechanism of action, revumenib may cause fetal harm when administered to pregnant women. Females of reproductive potential and males with female partners of reproductive potential are advised to use effective contraceptive measures during revumenib treatment and for 4 months following the last dose.
FDA，2025.10
