The U.S. Food and Drug Administration (FDA) approved Gazyva® to treat adults with lupus nephritis in October 2025. Gazyva targets and removes harmful B cells to help protect the kidneys in people with lupus nephritis. Below are answers to some questions you may have about this drug as you explore it as an option to help you manage your lupus.
What is Gazyva?
Gazyva is the brand name for obinutuzumab, a type of anti-CD20 monoclonal antibody treatment that has been approved by the FDA to help people with lupus nephritis. Gazyva is also used to treat some types of blood cancers.
Who developed Gazyva?
Gazyva was developed by Genentech, part of the Roche Group.
What makes Gazyva different from other lupus treatments?
Unlike some lupus medicines that broadly suppress the immune system, Gazyva specifically targets B cells. Clinical studies showed it helped more people achieve complete kidney recovery compared to standard treatment alone.
Who should take Gazyva? Will it work for everyone?
Gazyva is approved for adults with active lupus nephritis. In trials, about half of patients saw full kidney improvement. It may not work for everyone, so be sure to talk with your doctor about Gazyva.
Is Gazyva approved for use in children with lupus?
Not yet; studies in children and teens are ongoing.
Will there be further clinical trials on Gazyva?
Yes. Researchers are continuing to study Gazyva in lupus and other kidney-related conditions to learn more about how well it works.
Is Gazyva effective for individuals with lupus who have organ involvement beyond the kidneys?
So far, most of the evidence is for kidney disease. Studies are ongoing to see if it helps other organs affected by lupus.
What side effects have been found with Gazyva?
Some people may have serious infections, reactions during the infusion, or changes in blood cell counts. Other side effects may include fatigue, cough, muscle or joint pain, and digestive issues.
Patients should NOT receive Gazyva if they have had an allergic reaction to it. Patients must tell their healthcare provider if they have had an allergic reaction to obinutuzumab or any other ingredients in Gazyva in the past.
How is Gazyva administered?
Gazyva is given through an IV infusion by a healthcare provider at a clinic or infusion center—it is not meant to be administered at home. The exact dose and treatment schedule may vary.
Gazyva is given in addition to other medications used to treat lupus nephritis.
Should I receive vaccinations if I am taking Gazyva?
Before starting Gazyva, patients should inform their doctor about any recent or upcoming vaccinations. People who are taking Gazyva may need to delay vaccines or plan them around their infusion schedule.
How much does Gazyva cost?
The cost of Gazyva (obinutuzumab) varies based on many different factors. Learn more about financial assistance options here.
Where can I find more information about Gazyva?
Learn more information about Gazyva from the official website.