Prescription medicine
Obinutuzumab Brand names: Gazyva
Obinutuzumab (Gazyva) is a prescription medicine with an FDA approval on record since 2013. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the obinutuzumab FDA label on DailyMed (effective December 19, 2025, Genentech, Inc.); the BLA 125486 record on Drugs@FDA; every obinutuzumab label on DailyMed.
Highlights of the record
FDA label of December 19, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 [see Warnings and Precautions (5.1) ]. Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, can occur in patients receiving GAZYVA [see Warnings and Precautions (5.2) ]. WARNING: HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death. ( 5.1 ) Progressive Multifocal Leukoencephalopathy (PML) resulting in death.
Used for
From the label: indications and usageGAZYVA is a CD20-directed cytolytic antibody indicated: in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).
Forms and strengths
- 1000 mg/40ml
Injection (solution) (concentrate).
On the market
- Earliest approval on file
- November 1, 2013 Gazyva, Genentech; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 16,355 through July 30, 2026
What is obinutuzumab used for?
From the label: indications and usageGAZYVA is a CD20-directed cytolytic antibody indicated: in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). ( 1.1 , 14 ) in combination with bendamustine followed by GAZYVA monotherapy, for the treatment of patients with follicular lymphoma (FL)who relapsed after, or are refractory to, a rituximab-containing regimen. ( 1.2 , 14 ) in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma. […]
Conditions named in the indications of obinutuzumab's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: CD20-directed Cytolytic Antibody.
Source: FDA drug label (Gazyva), Genentech, Inc., effective December 19, 2025 (SPL set df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda), via openFDA; the full label on DailyMed
Is there a generic for obinutuzumab (Gazyva)?
No generic obinutuzumab is approved (Drugs@FDA, October 8, 2026).
- 2013 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the obinutuzumab label say about other medicines?
The obinutuzumab label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name obinutuzumab. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | warnings and precautions | WARNINGS AND PRECAUTIONS Infusion-Related Reactions: Premedicate patients with glucocorticoid, acetaminophen, and anti-histamine. Monitor patients closely during infusions. |
| Allopurinol | warnings and precautions | In patients with CLL and NHL at risk for TLS, administer appropriate tumor lysis prophylaxis with anti-hyperuricemics (e.g., allopurinol or rasburicase) and hydration prior to the infusion of GAZYVA [see Dosage and Administration (2.4) ]. |
| Bendamustine | warnings and precautions | CLL and FL In GALLIUM, more Grade 3 to 5 infections were reported in the recipients of GAZYVA and bendamustine (117/410 patients, 29%) as compared to GAZYVA plus CHOP or CVP (43/281 patients, 15%). |
| Epinephrine | warnings and precautions | Institute medical management (e.g., glucocorticoids, epinephrine, bronchodilators, and/or oxygen) for IRRs as needed. |
| Rasburicase | warnings and precautions | In patients with CLL and NHL at risk for TLS, administer appropriate tumor lysis prophylaxis with anti-hyperuricemics (e.g., allopurinol or rasburicase) and hydration prior to the infusion of GAZYVA [see Dosage and Administration (2.4) ]. |
Other labels that name obinutuzumab
Source: FDA drug label (Gazyva), Genentech, Inc., effective December 19, 2025 (SPL set df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda), via openFDA; the full label on DailyMed
What do FAERS reports show for obinutuzumab?
The FDA Adverse Event Reporting System holds 16,355 reports that list obinutuzumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,164 are coded as a death and 6,111 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as obinutuzumab?
36 other medicines are given the same way (intravenous) and in the same FDA class as obinutuzumab or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Rituximab | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 15 labelers | n/a | No current entry |
| Doxorubicin | Leukemia, lymphoma and myeloma | 16 labelers | n/a | No current entry |
| Bortezomib | Leukemia, lymphoma and myeloma | 22 labelers | n/a | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | 16 labelers | n/a | A presentation being discontinued |
| Bendamustine | Leukemia, lymphoma and myeloma | 4 labelers | n/a | A presentation being discontinued |
| Nelarabine | Leukemia, lymphoma and myeloma | 12 labelers | n/a | No current entry |
| Idarubicin | Leukemia, lymphoma and myeloma | 2 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as obinutuzumab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to obinutuzumab
- 36 medicines for the same use
- Other cd20-directed cytolytic antibodys
- the pharmacologic class, with prices and generics
- Obinutuzumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other