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Idhifa
enasidenib
Black Box Warnings .
Differentiation Syndrome
occurred in 14% of pts as early as 1 day and up to 5mo after tx start; can be fatal if untreated; if suspected, initiate corticosteroids and hemodynamic monitoring until sx resolved; s/sx incl. fever, dyspnea, acute resp. distress, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, lymphadenopathy, bone pain, and hepatic, renal, or multi-organ dysfxn; hospitalize pts w/ pulmonary and/or renal manifestation for close observation and monitoring; hold tx if severe pulmonary sx and/or persistent renal dysfxn
Adult Dosing .
Dosage forms: TAB: 50 mg, 100 mg
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments
IDH2-positive AML, relapsed or refractory
- [100 mg PO qd for at least 6mo]
- Info: do not cut/crush/chew tab
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- mild impairment: no adjustment; moderate-severe impairment: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.