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Gazyva
obinutuzumab
Black Box Warnings .
HBV Reactivation
can occur, incl. cases resulting in fulminant hepatitis, hepatic failure, and death; screen all pts for HBV infection before initial tx; monitor for s/sx HBV reactivation during tx and after D/C; D/C obinutuzumab and concomitant drugs if HBV reactivation occurs
Progressive Multifocal Leukoencephalopathy
can occur, incl. fatal PML
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
CLL/SLL, previously untreated
- [1000 mg IV x1 on day 1 of 28-day cycle, starting cycle 2]
- Start: 100 mg IV x1 on day 1, then 900 mg IV x1 on day 2, then 1000 mg IV x1 on days 8, 15 of 28-day cycle for cycle 1; Info: give x6 cycles; use w/ acalabrutinib, chlorambucil, ibrutinib, or venetoclax; give HBV prophylaxis before tx start, during tx, and for up to 12mo after D/C in anti-HBc positive pts
follicular lymphoma
- [previously untreated dz, combo w/ bendamustine]
- Dose: 1000 mg IV q2mo up to 24mo, starting after 1st 6 cycles complete; Start: 1000 mg IV x1 on days 1, 8, 15 of 28-day cycle for cycle 1, then 1000 mg IV x1 on day 1 of 28-day cycle x5 cycles; Info: use w/ bendamustine for 1st 6 cycles; give HBV prophylaxis before tx start, during tx, and for up to 12mo after D/C in anti-HBc positive pts
- [previously untreated dz, combo w/ CHOP]
- Dose: 1000 mg IV q2mo up to 24mo, starting after 1st 8 cycles complete; Start: 1000 mg IV x1 on days 1, 8, 15 of 21-day cycle for cycle 1, then 1000 mg IV x1 on day 1 of 21-day cycle x7 cycles; Info: use w/ CHOP for 1st 6 cycles; give HBV prophylaxis before tx start, during tx, and for up to 12mo after D/C in anti-HBc positive pts
- [previously untreated dz, combo w/ CVP]
- Dose: 1000 mg IV q2mo up to 24mo, starting after 1st 8 cycles complete; Start: 1000 mg IV x1 on days 1, 8, 15 of 21-day cycle for cycle 1, then 1000 mg IV x1 on day 1 of 21-day cycle x7 cycles; Info: use w/ CVP for 1st 8 cycles; give HBV prophylaxis before tx start, during tx, and for up to 12mo after D/C in anti-HBc positive pts
- [relapsed dz, combo w/ bendamustine]
- Dose: 1000 mg IV q2mo up to 24mo, starting after 1st 6 cycles complete; Start: 1000 mg IV x1 on days 1, 8, 15 of 28-day cycle for cycle 1, then 1000 mg IV x1 on day 1 of 28-day cycle x5 cycles; Info: use w/ bendamustine for 1st 6 cycles; give HBV prophylaxis before tx start, during tx, and for up to 12mo after D/C in anti-HBc positive pts
- [relapsed or refractory dz, combo w/ zanubrutinib (off-label)]
- Dose: 1000 mg IV q2mo up to 24mo, starting after 1st 6 cycles complete; Start: 1000 mg IV x1 on days 1, 8, 15 of 28-day cycle for cycle 1, then 1000 mg IV x1 on day 1 of 28-day cycle x5 cycles; Info: for pts refractory to at least 2 prior tx; give HBV prophylaxis before tx start, during tx, and for up to 12mo after D/C in anti-HBc positive pts
B-cell depleting pretreatment, pre-glofitamab (off-label)
- [1000 mg IV x1]
- Start: 7 days prior to glofitamab tx; Info: for pts w/ relapsed or refractory large B-cell lymphoma
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.