IV infusion Prophylaxis & premed for tumour lysis syndrome: Adequate hydration & administration of uricostatics (eg, allopurinol) or alternative eg, urate oxidase (eg, rasburicase) prior to start of infusion. Prophylaxis & premed for infusion-related reactions: Corticosteroid premed is recommended in FL patients & mandatory for CLL patients for 1st infusion.
CLL in combination w/ chlorambucil 1,000 mg over Days 1-2, & on Days 8 & 15 of the 1st 28-day treatment cycle followed by 1,000 mg on Day 1 only for each 28-day cycle for cycles 2-6. Duration of treatment: 6 cycles, each of 28-day duration. Cycle 1: Day 1: 100 mg infused at 25 mg/hr over 4 hr. Cycle 1: Day 2 or Day 1 (continued): 900 mg infused at 50 mg/hr, may be increased in increments of 50 mg/hr every 30 min to max rate of 400 mg/hr. If infusion-related reactions (IRR) occur during previous infusion, administer at 25 mg/hr, may be increased in increments of up to 50 mg/hr every 30 min to max rate of 400 mg/hr. Cycle 1: Day 8 & 15: 1,000 mg infused at 100 mg/hr, increased by 100 mg/hr increments every 30 min to max of 400 mg/hr. If IRR occur during previous infusion, administer at 50 mg/hr, may be increased in increments of 50 mg/hr every 30 min to max rate of 400 mg/hr. Cycles 2-6: Day 1: 1,000 mg infused at 100 mg/hr increased by 100 mg/hr increments every 30 min to a max of 400 mg/hr. If IRR occur during previous infusion, administer at 50 mg/hr, may be increased in increments of 50 mg/hr every 30 min to max rate of 400 mg/hr.
FL Cycle 1: Day 1: 1,000 mg IV at 50 mg/hr, may be increased in 50 mg/hr increments every 30 min to max of 400 mg/hr. Cycle 1: Day 8 & 15, & Cycles 2-6 or 2-8: Day 1: 1,000 mg starting at 100 mg/hr & increased by 100 mg/hr increments every 30 min to a max of 400 mg/hr, if no IRR or Grade 1 IRR occurs. If ≥Grade 2 IRR occurs, administer at 50 mg/hr, may be increased in 50 mg/hr increments every 30 min to a max of 400 mg/hr. Maintenance: 1,000 mg every 2 mth until progression or up to 2 yr.
Previously untreated FL Administered w/ chemotherapy six 28-day cycles in combination w/ bendamustine or six 21-day cycles in combination w/ CHOP, followed by 2 additional cycles of Gazyva alone, or eight 21-day cycles in combination w/ CVP. Patients who achieve complete or partial response to Gazyva + chemotherapy should continue to receive Gazyva (1,000 mg) alone as maintenance therapy once every 2 mth until disease progression or for up to 2 yr.
Relapsed/refractory FL patients Administered in six 28-day cycles in combination w/ bendamustine. Patients who achieve complete or partial response or have stable disease should continue to receive Gazyva 1,000 mg alone as maintenance therapy once every 2 mth until disease progression or for up to 2 yr.
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