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Gazyva

obinutuzumab
CD20-Directed AntibodyFDA Approved 2013Genentech/Roche
Route
IV
Half-Life
28.4 days
FDA Approved
2013
Manufacturer
Genentech/Roche
1. Indications and Usage

Previously untreated CLL with chlorambucil. R/R follicular lymphoma. Previously untreated advanced FL with chemotherapy.

2. Dosage and Administration

CLL: 100 mg IV Day 1, 900 mg Day 2 of Cycle 1; 1000 mg Days 8,15 Cycle 1; 1000 mg Day 1 Cycles 2-6. FL: 1000 mg IV Days 1,8,15 Cycle 1; Day 1 of subsequent cycles; maintenance Q2M up to 2 years.

3. Dosage Forms and Strengths

Injection: 1000 mg/40 mL (25 mg/mL) single-dose vial

4. Contraindications

None listed in the prescribing information.

5. Warnings and Precautions
  • HBV Reactivation: Screen before initiation.
  • PML: Consider diagnosis with new neurological symptoms.
  • Infusion Reactions: Very common. Premedicate.
  • Tumor Lysis Syndrome: Premedicate.
  • Infections: Serious infections reported.
  • Neutropenia: Monitor CBCs.
6. Adverse Reactions
Most Common Adverse Reactions

Infusion Reactions (69%), Neutropenia (40%), Thrombocytopenia (15%), Pyrexia (10%), Cough (10%), Nausea (8%)

Infusion Reactions
69%
Neutropenia
40%
Thrombocytopenia
15%
Pyrexia
10%
Cough
10%
Nausea
8%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

No formal drug interaction studies. Avoid live vaccines.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Obinutuzumab is a glycoengineered type II anti-CD20 antibody with enhanced ADCC and direct cell death induction compared to rituximab due to its modified Fc region.

Pharmacokinetics

Half-life: ~28 days. Volume of distribution: ~3.8 L. Clearance: 0.09 L/day.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Obinutuzumab Trials on ClinicalTrials.gov ↗ 📚 PubMed: Obinutuzumab Clinical Trials ↗
FDA-Approved Tumor Types

Gazyva has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Chronic Lymphocytic Leukemia Follicular Lymphoma
External Resources
📋 DailyMed Label ↗🏛️ FDA Drugs@FDA ↗🔬 ClinicalTrials.gov ↗📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Gazyva. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Gazyva (obinutuzumab) approved for?

Gazyva (obinutuzumab) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Gazyva (obinutuzumab) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Gazyva (obinutuzumab) work?

Obinutuzumab is a glycoengineered type II anti-CD20 antibody with enhanced ADCC and direct cell death induction compared to rituximab due to its modified Fc region.

What are the most common side effects?

Infusion Reactions (69%), Neutropenia (40%), Thrombocytopenia (15%), Pyrexia (10%), Cough (10%), Nausea (8%) Infusion Reactions 69% Neutropenia 40% Thrombocytopenia 15% Pyrexia 10% Cough 10% Nausea 8%

← All TherapiesFull Prescribing Information ↗