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Xospata
gilteritinib
Black Box Warnings .
Differentiation Syndrome
occurred in 3% of patients as early as 2 days and up to 75 days after tx start; can be fatal or life-threatening if untreated; if suspected, initiate corticosteroids and hemodynamic monitoring until symptoms resolved; administer corticosteroids for a minimum of 3 days; if severe signs/symptoms persists >48h after starting corticosteroids, hold tx until signs/symptoms no longer severe; signs/symptoms include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, or renal dysfunction with or without concomitant leukocytosis
Adult Dosing .
Dosage forms: TAB: 40 mg
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing including toxicity-related dose adjustments
FLT3-positive AML, relapsed or refractory
- [120 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]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.