• Chronic Lymphocytic Leukemia (CLL) in combination with chlorambucil in treatment-naïve patients:
    • Cycle 1 (Day 1, 2, 8, 15):
  • Day 1: 100 mg IV
  • Day 2: 900 mg IV
  • Day 8 & 15: 1000 mg IV
  • Cycles 2–6 (every 28 days):
    • IV 1000 mg on Day 1 of each cycle
  • Follicular Lymphoma (FL) in combination with chemotherapy (e.g., bendamustine) for previously untreated, who did not respond or progressed during/after rituximab therapy or as maintenance therapy in patients achieving response:
  • Induction (6–8 cycles):
    • IV 1000 mg on Days 1, 8, and 15 of Cycle 1 then IV 1000 mgDay 1 of subsequent cycles
  • Maintenance (every 2 months):
    • 1000 mg IV every 2 months for up to 2 years
  • 1000 mg/40 mL (25 mg/mL) in single-dose vial
  • IV infusion only
  • Premedicate with:
    • Acetaminophen
    • Antihistamine (e.g., diphenhydramine)
    • Corticosteroid (e.g., dexamethasone or methylprednisolone)
       To reduce infusion-related reactions
  • Start infusion slowly, increase rate if tolerated
  • Do not administer IV push or bolus
  • Must be diluted before IV infusion
  • Class: Anti-CD20 monoclonal antibody
  • Mechanism of Action:
    • Targets CD20 antigen on B lymphocytes
    • Causes B-cell lysis via antibody-dependent cellular cytotoxicity (ADCC), complement activation, and apoptosis
    • More potent than rituximab in some settings
  • Pharmacokinetics:
    • Half-life: ~28 days
    • Metabolized via protein catabolism pathways
  • Infusion-related reactions (fever, chills, hypotension)
  • Fatigue
  • Nausea
  • Diarrhea
  • Cough
  • Neutropenia, thrombocytopenia
  • Known hypersensitivity to obinutuzumab or any component
  • Caution in patients with active infections or severe neutropenia
  • Limited formal interaction studies
  • Avoid live vaccines during and after treatment
  • Increased risk of immunosuppression with other chemo or monoclonal antibodies

                                   Drug Status

Availability
Pregnancy
Breastfeeding
Schedule
BRAND NAME STRENGTH FORMULATION PACK SIZE MANUFACTURER DISTRIBUTOR
Gazyva 1g/40mL Injection 1’s F.Hoffman La-Roche Roche Kenya