Generic Name and Formulations:
Obinutuzumab 25mg/mL; soln for IV infusion after dilution; preservative-free.
Indications for GAZYVA:
In combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). In combination with bendamustine followed by Gazyva monotherapy, for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen. In combination with chemotherapy followed by Gazyva monotherapy, for the treatment of previously untreated stage II bulky, III or IV follicular lymphoma in patients achieving at least a partial remission.
See full labeling. Premedicate (eg, glucocorticoid, APAP, antihistamine) before each infusion. Provide prophylactic hydration and antihyperuricemics to those at high risk of TLS. Give by IV infusion for 6 treatment cycles (28 days duration). CLL: Cycle 1: 100mg on Day 1 at 25mg/hr over 4 hours; 900mg on Day 2 at 50mg/hr, can increase at 50mg/hr every 30mins to max 400mg/hr; 1000mg on Days 8 and 15 at 100mg/hr if no infusion reaction occurred previously, and increased by 100mg/hr increments every 30mins to max 400mg/hr; Cycles 2–6: 1000mg on Day 1 at 100mg/hr if no infusion reaction occurred previously, and increased by 100mg/hr increments every 30mins to max 400mg/hr. FL: Relapsed/refractory: give with bendamustine for six 28-day cycles; Previously untreated: give with either bendamustine for six 28-day cycles, with CVP for eight 21-day cycles, or with CHOP for six 21-day cycles followed by two additional 21-day cycles of Gayva monotherapy. Cycle 1: 1000mg on Day 1 at 50mg/hr, can increase at 50mg/hr every 30mins to max 400mg/hr; 1000mg on Days 8 and 15 at 100mg/hr if no infusion reaction occurred previously, and increased by 100mg/hr increments every 30mins to max 400mg/hr; Cycles 2–6 or 2–8: 1000mg on Day 1 at 100mg/hr if no infusion reaction occurred previously, and increased by 100mg/hr increments every 30mins to max 400mg/hr; followed by Gazyva monotherapy: 1000mg every 2 months for 2 years at 100mg/hr if no infusion reaction occurred previously, and increased by 100mg/hr increments every 30mins to max 400mg/hr. Management of infusion reactions, premedication: see full labeling.
Hepatitis B virus (HBV) reactivation. Progressive multifocal leukoencephalopathy (PML).
Risk of hepatitis B virus (HBV) reactivation; immediately discontinue and any concomitant chemotherapy if occurs. Screen for HBV infection prior to initiation; if positive evidence, monitor and consider antiviral therapy. Discontinue treatment and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressives if progressive multifocal leukoencephalopathy (PML) develops. Monitor closely for infusion reactions; if Grade 4: discontinue permanently; if Grade 3: interrupt until resolved; if Grade 1 or 2: interrupt or reduce the infusion rate and manage symptoms. Preexisting cardiac or pulmonary conditions: monitor more frequently during and post-infusion period for severe reactions. Risk of TLS in high tumor burden, high circulating lymphocyte count (>25 x 109/L), or renal impairment. Active infection: do not administer. Risk of neutropenia; monitor for signs of infection. Severe or prolonged neutropenia, give antimicrobial prophylaxis until resolved to Grade 1 or 2; consider antiviral and antifungal prophylaxis. Monitor for thrombocytopenia and hemorrhagic events esp. during the 1st cycle; if Grade 3 or 4 thrombocytopenia, obtain platelet counts more frequently until resolved; transfusion of blood products may be necessary. Consider interrupting therapy if infection, Grade 3 or 4 cytopenia, or ≥Grade 2 non-hematologic toxicity develops. Permanently discontinue if hypersensitivity reaction including serum sickness is suspected; do not retreat. Hepatic or renal impairment (CrCl <30mL/min). Pregnancy; risk of fetal B-cell depletion. Nursing mothers.
CD20-directed cytolytic monoclonal antibody.
Concomitant live viral vaccines: not recommended during treatment and until B-cell recovery (esp. neonates/infants if exposed to Gazyva in utero). Consider withholding antihypertensives for 12hrs prior to, during, and for 1hr after infusion until BP is stable. Consider withholding drugs that may increase bleeding risk (eg, platelet inhibitors, anticoagulants) esp. during 1st cycle.
Infusion reactions, neutropenia, thrombocytopenia, diarrhea, cough, constipation, pyrexia, upper RTI, arthralgia, sinusitis, asthenia, UTI, headache, insomnia, pneumonia, decreased appetite, alopecia, pruritus; HBV reactivation, PML, TLS, infections (may be fatal), hypersensitivity reactions.
Single-use vial (40mL)—1