Obinutuzumab

Generic Details

Generic Name

Obinutuzumab

Other Names

  • Gazyva

Drug Class

  • Monoclonal antibody

Chemical Formula

C6506H10058N1734O2028S42

Molecular Weight

145.7 kDa

Mechanism of Action

  • Binds to CD20 antigen on B-cells, leading to cell death via antibody-dependent cellular cytotoxicity

Indications

  • Chronic lymphocytic leukemia (CLL)
  • Follicular lymphoma

Common Dosage Forms

  • Injection

Typical Dosage

  • 1000 mg on day 1, 1000 mg on day 8, then 1000 mg every 28 days for up to 6 cycles

Pediatric Dosage

  • Safety and efficacy not established in children

Geriatric Dosage

  • Dosage adjustment may be necessary based on individual patient factors

Side Effects

  • Infusion reactions
  • Neutropenia
  • Thrombocytopenia
  • Fatigue
  • Nausea
  • Diarrhea

Contraindications

  • Hypersensitivity to obinutuzumab
  • Active infections

Pregnancy Category

  • Category C - Risk cannot be ruled out

Lactation Safety

  • Unknown if excreted in breast milk, consult healthcare provider

Drug Interactions

  • Live vaccines
  • Immunosuppressive agents

Overdose Symptoms

  • Increased risk of infections
  • Hepatic and renal impairment

Antidote for Overdose

  • No specific antidote, manage symptoms and provide supportive care

Storage Conditions

  • Refrigerate at 2°C to 8°C (36°F to 46°F), do not freeze

Pharmacokinetics

  • Absorption: Bioavailability is not applicable as it is administered intravenously
  • Distribution: Highly protein-bound
  • Metabolism: Metabolic pathway not fully elucidated
  • Excretion: Mainly through reticuloendothelial system and kidneys

Precautions

  • Monitor for signs of infections during treatment
  • Hepatic and renal function tests

Warnings

  • Infusion reactions can occur, administer in a healthcare setting with monitoring

Others

  • Regular blood cell counts recommended during treatment