Brand Name

Gazyva

Generic Name
Obinutuzumab
View Brand Information
FDA approval date: November 01, 2013
Classification: CD20-directed Cytolytic Antibody
Form: Injection

What is Gazyva (Obinutuzumab)?

Receiving a cancer diagnosis can be one of life’s most challenging experiences, both emotionally and physically. Treatments that target cancer cells precisely while sparing healthy tissue can make a meaningful difference in a patient’s journey. Gazyva (obinutuzumab) is one such therapy, developed to help people with certain blood cancers live longer, healthier lives. 

Gazyva is a monoclonal antibody, a type of targeted therapy that recognizes and attaches to specific proteins on cancer cells. It is approved by the U.S. Food and Drug Administration (FDA) to treat chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL), both of which are cancers of the lymphatic system. By focusing on a particular target found on cancerous B cells, Gazyva helps the immune system attack and destroy these cells more effectively. 

As part of a modern approach to cancer care, Gazyva is typically used in combination with other medications such as chlorambucil or bendamustine. It represents a newer generation of antibody-based treatments, offering an important option for patients whose disease has not responded to earlier therapies or who are starting treatment for the first time. 

What does Gazyva do? 

Gazyva is designed to treat blood cancers that affect B cells, a type of white blood cell responsible for fighting infections. When B cells grow uncontrollably or fail to die at the right time, they can form cancerous cells leading to conditions like CLL and follicular lymphoma. 

In patients with chronic lymphocytic leukemia, Gazyva helps lower the number of abnormal lymphocytes in the blood and bone marrow, improving immune function and easing symptoms such as fatigue, swollen lymph nodes, and night sweats. In follicular lymphoma, a slower-growing but persistent form of non-Hodgkin lymphoma, Gazyva can help control disease progression and delay the need for more aggressive treatments. 

Clinical trials have shown that combining Gazyva with chemotherapy drugs improves progression-free survival, meaning patients live longer without their cancer worsening, compared to chemotherapy alone (NIH, 2024). 

How does Gazyva work? 

Gazyva works by targeting a protein called CD20, which is found on the surface of both normal and cancerous B cells. Once Gazyva binds to this protein, it triggers the immune system to attack and destroy those cells. 

In simple terms, Gazyva helps the body recognize and eliminate cancerous B cells more efficiently. It does this through two main actions: 

  1. Direct cell killing: Gazyva can directly damage the cancer cell’s outer membrane, leading to its destruction. 
     
  1. Immune system activation: It signals the immune system’s natural killer cells and other defenses to identify and remove the tagged cancer cells. 

This targeted mechanism is clinically important because it focuses on the harmful cells while sparing most healthy cells. Over time, as the cancerous B cells are cleared, the bone marrow can produce healthy immune cells again, helping restore immune balance. 

Gazyva side effects 

While Gazyva offers significant benefits, it can also cause side effects especially during or shortly after infusions. Most reactions are manageable with close medical supervision and pre-treatment medications. 

Common side effects include: 

  • Fatigue 
     
  • Fever or chills during infusion 
     
  • Nausea or vomiting 
     
  • Low white blood cell counts (which can increase infection risk) 
     
  • Muscle or joint pain 
     
  • Diarrhea or constipation 

Serious side effects (less common) may include: 

  • Severe infusion-related reactions (such as trouble breathing, dizziness, or rash) 
     
  • Infections, including reactivation of hepatitis B 
     
  • Low platelet counts, which can cause easy bruising or bleeding 
     
  • Tumor lysis syndrome, a condition caused by the rapid breakdown of cancer cells 
     
  • Rarely, brain infections such as progressive multifocal leukoencephalopathy (PML) 

Doctors minimize risks by administering the drug slowly, premedicating, and performing regular blood tests. Patients should immediately contact their healthcare provider if they experience persistent fever, sudden confusion, breathing difficulties, or unusual bleeding.  

Gazyva is not recommended for those with active infections or certain immune deficiencies unless directed by a physician. 

Gazyva dosage 

Gazyva, an IV infusion, is given in a clinic or hospital, allowing monitoring for reactions. The schedule and duration vary based on the condition (CLL or follicular lymphoma) and treatment stage (first-time or relapsed). It’s typically given in cycles, often with chemotherapy. Infusions, especially the first, can last several hours to minimize reactions. 

Doctors monitor blood counts, liver function, and infection signs during therapy for safety and effectiveness. Pre-medication may be given for nausea, fever, or allergic reactions. Older adults and those with pre-existing conditions like heart or liver disease usually don’t need dose adjustments but may require closer observation for side effects. 

Does Gazyva have a generic version? 

As of 2025, Gazyva (obinutuzumab) does not have a generic or biosimilar version approved in the United States. It remains available only as the brand-name product manufactured by Genentech (a member of the Roche Group). However, international versions may exist in other markets. 

Gazyva is a complex biologic medication. When future biosimilar versions become available, the FDA will require them to demonstrate equivalent safety, potency, and effectiveness. Currently, Gazyva is available through authorized centers with cost support from insurance or patient-assistance programs. 

Conclusion 

Gazyva represents a significant advancement in targeted cancer therapy, offering new hope for patients with chronic lymphocytic leukemia and follicular lymphoma. By helping the immune system recognize and destroy cancerous B cells, it delivers a focused and effective approach to treatment. 

Though requiring careful monitoring and potential side effects, Gazyva is generally well-tolerated under expert oncology care. Its benefits, like extended remission and better quality of life, make it a key cancer treatment. If prescribed, maintain open communication with your healthcare provider, attend appointments, and report side effects for safe and successful treatment. 

References 

  1. U.S. Food and Drug Administration (FDA). (2024). Gazyva (obinutuzumab) prescribing information. Retrieved from https://www.accessdata.fda.gov 
     
  1. Mayo Clinic. (2024). Obinutuzumab (intravenous route) drug information. Retrieved from https://www.mayoclinic.org 
     
  1. MedlinePlus. (2024). Obinutuzumab: Uses, side effects, and precautions. National Library of Medicine. Retrieved from https://medlineplus.gov 
     
  1. National Institutes of Health (NIH). (2024). Monoclonal antibodies in blood cancer treatment. Retrieved from https://www.nih.gov 

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Brand Information

Gazyva (obinutuzumab)
WARNING: HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
  • Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients receiving CD20-directed cytolytic antibodies, including GAZYVA. Screen all patients for HBV infection before treatment initiation. Monitor HBV-positive patients during and after treatment with GAZYVA. Discontinue GAZYVA and concomitant medications in the event of HBV reactivation
  • Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, can occur in patients receiving GAZYVA
1DOSAGE FORMS AND STRENGTHS
Injection: 1,000 mg/40 mL (25 mg/mL) clear, colorless to slightly brown solution in a single-dose vial.
2CONTRAINDICATIONS
GAZYVA is contraindicated in patients with known hypersensitivity reactions (e.g., anaphylaxis) to obinutuzumab or to any of the excipients, or serum sickness with prior obinutuzumab use
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
  • Hepatitis B virus reactivation
  • Progressive multifocal leukoencephalopathy
  • Infusion-related reactions
  • Hypersensitivity reactions including serum sickness
  • Tumor lysis syndrome
  • Infections
  • Neutropenia
  • Thrombocytopenia
  • Disseminated intravascular coagulation
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
3.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of GAZYVA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Immune/Autoimmune Events: Serum sickness
4OVERDOSAGE
There has been no experience with overdose in human clinical trials. For patients who experience overdose, treatment should consist of immediate interruption or reduction of GAZYVA and supportive therapy.
5DESCRIPTION
Obinutuzumab is a humanized anti-CD20 monoclonal antibody of the IgG1 subclass. It recognizes a specific epitope of the CD20 molecule found on B cells. The molecular mass of the antibody is approximately 150 kDa.
GAZYVA (obinutuzumab) injection is produced by mammalian cell (CHO) suspension culture. GAZYVA was engineered to have reduced fucose content as compared to a typical IgG1 produced in CHO cells. GAZYVA is a sterile, clear, colorless to slightly brown, preservative-free liquid concentrate for intravenous use. GAZYVA is supplied at a concentration of 25 mg/mL in 1,000 mg single-dose vials. Each vial contains in 40 mL: 1,000 mg obinutuzumab, L-histidine (57.6 mg), L-histidine hydrochloride monohydrate (89.6 mg), trehalose dihydrate (3632 mg), and poloxamer 188 (8 mg). The pH is 6.0.
6HOW SUPPLIED/STORAGE AND HANDLING
GAZYVA (obinutuzumab) injection is a clear, colorless to slightly brown, preservative-free solution for intravenous use supplied as 1,000 mg/40 mL (25 mg/mL) in single-dose vials (NDC 50242-070-01).
7PRINCIPAL DISPLAY PANEL - 40 mL Vial Carton
NDC 50242-070-01
Gazyva
1000 mg/40 mL
For Intravenous Infusion After Dilution.
1 vial
Rx only
Genentech
10240530
Principal Display Panel - 40 mL Vial Carton