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Revuforj
revumenib
Black Box Warnings .
Differentiation Syndrome
incl. fatal or life-threatening cases, occurred in 29% of pts; reduce WBC to <25,000 before tx start; s/sx incl. fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid wt gain, peripheral edema, hypotension, or renal dysfunction; if suspected, initiate corticosteroids and hemodynamic monitoring for minimum of 3 days and until sx resolved; interrupt tx if severe s/sx persist for >48h after corticosteroid start or for life-threatening sx such as pulmonary sx requiring ventilator support
Adult Dosing .
Dosage forms: TAB: 25 mg, 110 mg, 160 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
KMT2A-translocated acute leukemia, relapsed or refractory
- [<40 kg, BSA 1 m^2]
- Dose: 160 mg PO bid; Info: give on empty stomach or w/ low fat meal; give for at least 6mo
- [<40 kg, BSA 1.1-1.2 m^2]
- Dose: 185 mg PO bid; Info: give on empty stomach or w/ low fat meal; give for at least 6mo
- [<40 kg, BSA 1.3-1.4 m^2]
- Dose: 220 mg PO bid; Info: give on empty stomach or w/ low fat meal; give for at least 6mo
- [>40 kg]
- Dose: 270 mg PO bid; Info: give on empty stomach or w/ low fat meal; give for at least 6mo
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1.1-3x ULN or AST >ULN: no adjustment; bilirubin >3x ULN: not defined
Peds Dosing .
- Dosage forms: TAB: 25 mg, 110 mg, 160 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
KMT2A-translocated acute leukemia, relapsed or refractory
- [1 yo and older, <40 kg, BSA 0.4 m^2]
- Dose: 50 mg PO bid; Info: give on empty stomach or w/ low fat meal; give for at least 6mo
- [1 yo and older, <40 kg, BSA 0.5 m^2]
- Dose: 75 mg PO bid; Info: give on empty stomach or w/ low fat meal; give for at least 6mo
- [1 yo and older, <40 kg, BSA 0.6 m^2]
- Dose: 100 mg PO bid; Info: give on empty stomach or w/ low fat meal; give for at least 6mo
- [1 yo and older, <40 kg, BSA 0.7 m^2]
- Dose: 110 mg PO bid; Info: give on empty stomach or w/ low fat meal; give for at least 6mo
- [1 yo and older, <40 kg, BSA 0.8-0.9 m^2]
- Dose: 135 mg PO bid; Info: give on empty stomach or w/ low fat meal; give for at least 6mo
- [1 yo and older, <40 kg, BSA 1 m^2]
- Dose: 160 mg PO bid; Info: give on empty stomach or w/ low fat meal; give for at least 6mo
- [1 yo and older, <40 kg, BSA 1.1-1.2 m^2]
- Dose: 185 mg PO bid; Info: give on empty stomach or w/ low fat meal; give for at least 6mo
- [1 yo and older, <40 kg, BSA 1.3-1.4 m^2]
- Dose: 220 mg PO bid; Info: give on empty stomach or w/ low fat meal; give for at least 6mo
- [1 yo and older, >40 kg]
- Dose: 270 mg PO bid; Info: give on empty stomach or w/ low fat meal; give for at least 6mo
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1.1-3x ULN or AST >ULN: no adjustment; bilirubin >3x ULN: not defined