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ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › ANTINEOPLASTIC AGENTS › MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES › CD20 (Clusters of Differentiation 20) inhibitors
obinutuzumab
L01FA03
Forms & Strengths
- Intravenous infusion: 1000 mg / 40 mL single-dose vial
Adult Dosing
- Chronic lymphocytic leukemia (CLL): 1000 mg IV on days 1, 8, and 15 of cycle 1, then day 1 of cycles 2-6 (28-day cycles) in combination with chlorambucil
- Follicular lymphoma (FL): 1000 mg IV on days 1, 8, and 15 of cycle 1, then day 1 of cycles 2-6 (bendamustine combo) or cycles 2-8 (CHOP/CVP combo), followed by obinutuzumab maintenance every 2 months for 2 years
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established
Indications
- Chronic lymphocytic leukemia (CLL) in combination with chlorambucil
- Follicular lymphoma (FL) previously untreated or relapsed/refractory, in combination with chemotherapy followed by maintenance in responders
Mechanism of Action
- Monoclonal antibody targeting CD20 expressed on B-cells
- Induces direct cell death and robust antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP)
- Engineered (glycoengineered) to increase affinity for FcγRIII receptors on immune effector cells
Contraindications
- Known hypersensitivity to obinutuzumab or any of its excipients
Adverse Reactions
- Infusion-related reactions (hypotension, tachycardia, dyspnea, fever)
- Neutropenia, thrombocytopenia, anemia
- Infections (upper respiratory tract infection, pneumonia)
- Musculoskeletal pain, fatigue, cough
- Progressive multifocal leukoencephalopathy (PML) rare risk
- Tumor lysis syndrome
Drug Interactions
- Live vaccines: risk of infection, avoid administration during and after therapy until B-cell recovery
- Antihypertensives: risk of transient hypotension during infusion, consider withholding antihypertensives 12 hours prior to and throughout infusion
Curated Content: Needs Vetting Before Put to Clinical Use