Pronunciation: gaz-ee-vah
Generic name: obinutuzumab
Dosage form: single-dose vial for intravenous infusion (25 mg/mL)
Drug class: CD20 monoclonal antibodies
What Is Gazyva?
Gazyva (obinutuzumab) is targeted immunotherapy treatment that works with your immune system to treat specific types of blood cancers. Gazyva is a prescription medicine administered intravenously by a healthcare professional, typically alongside other cancer treatments. Currently, no generic version is available.
FDA-Approved Uses for Gazyva
Gazyva is specifically approved for adults with:
- Chronic lymphocytic leukemia (CLL): For first-time treatment in combination with chlorambucil
- Follicular lymphoma (FL): For patients whose cancer has relapsed or not responded to rituximab-containing regimens, used with bendamustine followed by Gazyva maintenance therapy
- Stage II bulky, III, or IV follicular lymphoma: For first-time treatment, used with chemotherapy first, then as monotherapy if treatment is successful
How Gazyva Works
Gazyva targets a protein called CD20 that appears on both normal and cancerous B-lymphocytes (a type of white blood cell). By binding to this protein, Gazyva:
- Helps your immune system identify and destroy marked cells
- Directly attacks cancer cells
- Preserves stem cells in bone marrow, allowing your body to keep producing healthy blood cells.
Clinical Effectiveness
Clinical trials have demonstrated that CLL patients receiving Gazyva plus chlorambucil experienced:
- Nearly 80% partial or complete response rate (versus 66.3% with rituximab plus chlorambucil)
- Approximately one additional year without cancer progression (26.7 months versus 14.9 months with rituximab plus chlorambucil).
Common Side Effects
The most common side effects of Gazyva are:
- Infusion-related reactions
- Low white blood cell counts (neutropenia)
- Fatigue
- Nausea
- Fever
- Cough.
Serious Side Effects and Warnings
Boxed Warnings
Gazyva carries FDA Boxed Warnings for:
- Hepatitis B Virus (HBV) Reactivation: Can cause liver failure or death in patients with previous HBV infection
- Progressive Multifocal Leukoencephalopathy (PML): A rare, serious brain infection that can be fatal
Additional Serious Risks
- Infusion-Related Reactions (IRRs): May occur during or within 24 hours of infusion
- Severe Allergic Reactions: Including anaphylaxis and serum sickness
- Tumor Lysis Syndrome (TLS): Rapid breakdown of cancer cells causing metabolic complications
- Infections: May be severe or fatal
- Low Blood Cell Counts: Including neutropenia (white cells) and thrombocytopenia (platelets)
- Disseminated Intravascular Coagulation (DIC): A rare but potentially fatal blood clotting disorder.
These are not all the possible side effects of Gazyva. For more information, ask your doctor or pharmacist.
Tell your doctor right away about any side effects you experience. You may report side effects to the FDA at (800) FDA-1088, or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Before receiving Gazyva
Contraindications
Do NOT receive Gazyva if you’ve had an allergic reaction to obinutuzumab or any ingredients in the injection.
Important Disclosures to Your Doctor
Tell your healthcare provider if you:
- Have heart disease
- Have any infection, particularly hepatitis B
- Have lung or breathing problems
- Recently received or plan to receive vaccines
- Take blood-thinning medications
- Are pregnant, planning pregnancy, or breastfeeding.
Pregnancy and Breastfeeding
- Pregnancy: Gazyva may harm unborn babies. Use effective contraception during treatment and for 6 months afterward.
- Breastfeeding: Not recommended during treatment and for 6 months after the last dose due to potential risks to infants.
- Vaccinations: Discuss timing of live virus vaccines for infants if you received Gazyva during pregnancy.
Gazyva Administration and Dosing Schedule
Gazyva is administered as an intravenous infusion in a clinic or infusion center. Most people will complete their Gazyva treatment in about 6 months.
Treatment Format
- 6 treatment cycles of 28 days each (6 months total).
- Gradual dose increases during Cycle 1 to minimize side effects
- For CLL patients: Chlorambucil on Day 1 and Day 15 of each cycle.
Dosing Schedule
Cycle 1:
- Day 1: 100 mg
- Day 2: 900 mg
- Day 8: 1000 mg
- Day 15: 1000 mg
Cycles 2-6:
Day 1: 1000 mg
Preparing for Infusions
One Week Before:
- Review all medications with your doctor
- Discuss blood pressure medications that might need adjustment.
Day of the Infusion:
- Arrange transportation home
- Wear comfortable clothing
- Bring snacks, entertainment, and activities
- Expect to spend most of the day at the facility.
Pre-Medications:
Your doctor may prescribe medications one hour before infusion to reduce side effects:
- Acetaminophen
- Antihistamines
- Steroids.
Ongoing Monitoring
During treatment, your doctor will regularly assess:
- Symptoms
- Lymph node, liver, and spleen size
- Blood counts
- Side effects.
What to Avoid During Treatment
Live vaccines: Do not receive BCG, MMR, MMRV, rotavirus, or varicella vaccines during Gazyva treatment
Manufacturer Information
Gazyva is manufactured by Genentech, a subsidiary of Roche. Genentech is headquartered in South San Francisco, California, while Roche’s global headquarters is in Basel, Switzerland. Other Notable Medications from Genentech/Roche include:
- Avastin (bevacizumab)
- Herceptin (trastuzumab)
- Rituxan (rituximab)
- Tecentriq (atezolizumab)
- Perjeta (pertuzumab)
- Actemra (tocilizumab) for rheumatoid arthritis
- Ocrevus (ocrelizumab) for multiple sclerosis
- Lucentis (ranibizumab) for eye conditions
- Xolair (omalizumab) for asthma and allergies
- Hemlibra (emicizumab) for hemophilia A.
Gazyva Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Gazyva.Gazyva (obinutuzumab) – Genentech, Inc.
| Formulation type | Strength |
|---|---|
| Single-Dose Vial | 1,000 mg/40 mL (25 mg/mL) |
