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Mylotarg
gemtuzumab ozogamicin
Black Box Warnings .
Hepatotoxicity
incl. severe or fatal hepatic veno-occlusive dz (VOD) reported w/ use as single agent, and as part of combo chemo regimen; incr. VOD risk if receiving higher doses as monotherapy, mod-severe hepatic impairment, prior HSCT, undergoing HSCT post tx; monitor LFTs prior to each dose; monitor frequently VOD s/sx incl. elevated LFTs, hepatomegaly, rapid wt gain, ascites; if VOD occurs, D/C tx and treat VOD according to standard medical practice
Adult Dosing .
Dosage forms: INJ
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, and dosing incl. toxicity-related dose adjustments
CD33-positive AML, newly diagnosed
- [combo tx, induction tx]
- Dose: 3 mg/m^2/dose IV x1 on day 1, 4, 7 of cycle 1 only; Max: 4.5 mg/dose; Info: cytoreduction recommended prior to 1st dose if leukocyte count >30,000
- [combo tx, consolidation tx]
- Dose: 3 mg/m^2/dose IV x1 on day 1 of cycle; Max: 4.5 mg/dose; Info: give x2 cycles; cytoreduction recommended prior to 1st dose if leukocyte count >30,000
- [monotherapy]
- Dose: 6 mg/m^2/dose IV x1 on day 1, then 3 mg/m^2/dose IV x1 on day 8 of induction tx, then cont. tx 2 mg/m^2/dose IV x1 on day 1 of 28-day cycle for up to 8 cycles; Info: cytoreduction recommended prior to 1st dose if leukocyte count >30,000
CD33-positive AML, relapsed or refractory
- [3 mg/m^2/dose IV x1 on days 1, 4, 7 of cycle]
- Max: 4.5 mg/dose; Info: give x1 cycle; cytoreduction recommended prior to 1st dose if leukocyte count >30,000
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, caution advised
Peds Dosing .
- Dosage forms: INJ
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, and dosing incl. toxicity-related dose adjustments
CD33-positive AML, newly diagnosed
- [induction tx, 1mo and older, BSA <0.6 m^2]
- Dose: 0.1 mg/kg/dose IV x1 only; Max: 4.5 mg/dose; Info: cytoreduction recommended prior to 1st dose if leukocyte count >30,000; part of multi-drug chemo regimen
- [intensification tx, 1mo and older, BSA <0.6 m^2]
- Dose: 0.1 mg/kg/dose IV x1 at cycle 2 only; Max: 4.5 mg/dose; Info: give x3 cycles; cytoreduction recommended prior to 1st dose if leukocyte count >30,000; part of multi-drug chemo regimen
- [induction tx, 1mo and older, BSA >0.6 m^2]
- Dose: 3 mg/m^2/dose IV x1 only; Max: 4.5 mg/dose; Info: cytoreduction recommended prior to 1st dose if leukocyte count >30,000; part of multi-drug chemo regimen
- [intensification tx, 1mo and older, BSA >0.6 m^2]
- Dose: 3 mg/m^2/dose IV x1 at cycle 2 only; Max: 4.5 mg/dose; Info: give x3 cycles; cytoreduction recommended prior to 1st dose if leukocyte count >30,000; part of multi-drug chemo regimen
CD33-positive AML, relapsed or refractory
- [2 yo and older]
- Dose: 3 mg/m^2/dose IV x1 on days 1, 4, 7 of cycle; Max: 4.5 mg/dose; Info: give x1 cycle; cytoreduction recommended prior to 1st dose if leukocyte count >30,000; part of multi-drug chemo regimen
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, caution advised