Gazyva (obinutuzumab)
An approved treatment for Lupus Nephritis.
The same compound appears under different names depending on the context. Here is how to identify Obinutuzumab wherever you encounter it, plus the key facts at a glance.
- Generic name
- Obinutuzumab
- Brand name
- Gazyva
- Drug class
- Monoclonal antibody (anti-CD20)
- Manufacturer
- Genentech (Roche)
- How it's taken
- A 1,000 mg infusion by vein on the first day and at weeks 2, 24 and 26, then every 6 months.
An infusion, first approved for blood cancers, that the FDA approved in October 2025 for adults with active lupus nephritis who are receiving standard therapy.
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Where Obinutuzumab fits
Added to standard therapy for adults with active lupus nephritis, given twice a year after the first 4 infusions.
How Obinutuzumab works
Obinutuzumab attaches to CD20, a marker on B cells, and removes them. B cells make the autoantibodies that drive lupus, so lowering them calms the immune attack on the kidneys.
Mechanism: Anti-CD20 antibody that removes B cells
Side effects and safety
Gazyva has a boxed warning for hepatitis B coming back and for PML, a rare, serious brain infection. In the pooled lupus nephritis trials, the most common side effects against placebo were upper respiratory infections (29% against 24%), COVID-19 (23% against 16%), urinary tract infections (21% against 18%), bronchitis (14% against 8%), infusion reactions (14% against 10%), low white blood cell counts (14% against 6%) and pneumonia (10% against 6%).
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Obinutuzumab
A 1,000 mg infusion by vein on the first day and at weeks 2, 24 and 26, then every 6 months. From the second dose, eligible patients can have a shorter 90-minute infusion.
Availability and cost
Only available as the brand-name product.
Help paying for Gazyva
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
The GAZYVA Immunology Co-pay Program lets eligible patients with commercial insurance pay as little as $0, covering up to $15,000 a year for the medicine and up to $2,000 a year for infusion costs.
For: private insurance · source - Free medicine program
The Genentech Patient Foundation may give Gazyva free to eligible patients, for example uninsured people with household income under $150,000.
For: no insurance · source
Access and eligibility
For lupus nephritis, approved for adults with active disease who are receiving standard therapy.
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
In REGENCY (NCT04221477), 271 adults with lupus nephritis added Gazyva or placebo to standard therapy. At week 76, 46.4% on Gazyva had a complete kidney response against 33.1% on placebo.
Development history
First approved by the FDA on November 1, 2013 for chronic lymphocytic leukemia. The lupus nephritis approval followed in October 2025, and an approval for childhood-onset idiopathic nephrotic syndrome on September 25, 2026.
Explore Lupus Nephritis trials
Other Lupus Nephritis treatments
Common questions about Obinutuzumab
▸What is Obinutuzumab (Gazyva)?
An infusion, first approved for blood cancers, that the FDA approved in October 2025 for adults with active lupus nephritis who are receiving standard therapy.
▸How does Obinutuzumab work?
Obinutuzumab attaches to CD20, a marker on B cells, and removes them. B cells make the autoantibodies that drive lupus, so lowering them calms the immune attack on the kidneys.
▸What are the side effects of Obinutuzumab?
Gazyva has a boxed warning for hepatitis B coming back and for PML, a rare, serious brain infection. In the pooled lupus nephritis trials, the most common side effects against placebo were upper respiratory infections (29% against 24%), COVID-19 (23% against 16%), urinary tract infections (21% against 18%), bronchitis (14% against 8%), infusion reactions (14% against 10%), low white blood cell counts (14% against 6%) and pneumonia (10% against 6%).
▸How is Obinutuzumab taken?
A 1,000 mg infusion by vein on the first day and at weeks 2, 24 and 26, then every 6 months. From the second dose, eligible patients can have a shorter 90-minute infusion.
▸Is Obinutuzumab FDA approved?
Yes, Obinutuzumab (Gazyva) is FDA approved (2013) for the treatment of Lupus Nephritis.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed · 2025-12. GAZYVA (obinutuzumab) injection: prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda
- Roche · 2025-10-20. FDA approves Roche's Gazyva for the treatment of lupus nephritis. https://www.roche.com/media/releases/med-cor-2025-10-20
- ClinicalTrials.gov. REGENCY: obinutuzumab in lupus nephritis. https://clinicaltrials.gov/study/NCT04221477