Gazyva

• Previously untreated chronic lymphocytic leukemia (with chlorambucil)
• Previously untreated follicular lymphoma (with chemotherapy + maintenance)
• Refractory or relapsed follicular lymphoma (with bendamustine + maintenance)

CLL (with Chlorambucil, 6 x 28-day cycles):

• Cycle 1, Day 1: 100 mg at 25 mg/hour over 4 hours; Day 2: 900 mg at 25-50 mg/hour, increased by 50 mg/hour every 30 min to max 400 mg/hour; Days 8 & 15: 1,000 mg at 50-100 mg/hour, increased by 50-100 mg/hour every 30 min to max 400 mg/hour
• Cycles 2-6, Day 1: 1,000 mg at 50-100 mg/hour to max 400 mg/hour

FL (Induction + Maintenance): Induction: 1,000 mg on Cycle 1, Days 1,8,15 and Cycles 2-6/8, Day 1; Maintenance: 1,000 mg every 2 months for up to 2 years

Common Side Effects (>10%):

• Infusion related reactions (69%)
• Neutropenia (33%)
• Hypocalcemia (32%)
• Hyperkalemia (31%)
• Hyponatremia (29%)
• Creatinine increased (28%)
• AST/SGOT increased (28%)
• AST/SGPT increased (25%)
• Hypoalbuminemia (16%)
• Alkaline phosphatase increased (16%)
• Thrombocytopenia (15%)
• Hypokalemia (13%)
• Anemia (12%)

Serious: Hepatitis B reactivation, PML, tumor lysis syndrome, infections

Use in Pregnancy: Obinutuzumab is highly unsafe during pregnancy; animal studies show fetal B-cell depletion; consider potential risk to fetus.

• Caution in patients with history or current hepatitis B virus infection
• Risk of tumor lysis syndrome (high tumor burden, high lymphocyte count)
• Cardiac and respiratory impairment
• Caution in renal impairment
• Avoid live viral vaccines
• Caution during pregnancy and lactation