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Tibsovo
ivosidenib
Black Box Warnings .
Differentiation Syndrome in AML and Myelodysplastic Syndrome
occurred as early as 1 day and up to 3mo after tx start; may be life-threatening or fatal; if suspected, initiate corticosteroids and hemodynamic monitoring until sx resolution; initiate hydroxyurea or leukapheresis as clinically indicated if concomitant noninfectious leukocytosis; taper corticosteroids and hydroxyurea after sx resolution; admin. corticosteroids for at least 3 days; if severe s/sx persists >48h after starting corticosteroids, hold tx until s/sx no longer severe; s/sx incl. fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfxn
Adult Dosing .
Dosage forms: TAB: 250 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
IDH1-mutated AML
- [newly diagnosed dz]
- Dose: 500 mg PO qd for at least 6mo; Info: for pts 75 yo and older, or who are ineligible for intensive induction chemo d/t comorbidities; use w/ azacitidine or as monotherapy; do not cut/crush/chew tab; avoid admin. w/ high fat meal
- [relapsed or refractory dz]
- Dose: 500 mg PO qd for at least 6mo; Info: do not cut/crush/chew tab; avoid admin. w/ high fat meal
IDH1-mutated myelodysplastic syndrome, relapsed or refractory
- [500 mg PO qd for at least 6mo]
- Info: do not cut/crush/chew tab; avoid admin. w/ high fat meal
IDH1-mutated cholangiocarcinoma, locally advanced or metastatic
- [500 mg PO qd]
- Info: for pts w/ previously treated dz; do not cut/crush/chew tab; avoid admin. w/ high fat meal
renal dosing
- [see below]
- eGFR >30: no adjustment; eGFR <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.