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Gazyva®: What you need to know
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.
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.
Gazyva works to deplete disease-causing B cells by targeting the CD20 receptor expressed on B cells. This depletion aims to protect the kidney from further damage and potentially prevent or delay progression to kidney failure by reducing inflammation in the body. Kidney failure happens when a person’s kidneys stop functioning, requiring dialysis or kidney transplant.
Gazyva was developed by Genentech, part of the Roche Group.
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.
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.
Not yet. Studies in children and teens are ongoing.
Yes. Researchers are continuing to study Gazyva in lupus and other kidney-related conditions to learn more about how well it works.
So far, most of the evidence is for kidney disease. Studies are ongoing to see if it helps other organs affected by lupus.
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.
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.
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.
The cost of Gazyva varies based on many different factors. Learn more about financial assistance options here.
Learn more information about Gazyva from the official website.
Following the FDA’s approval of Gazyva® (obinutuzumab) for the treatment of adults with lupus nephritis, Dr. Brad Rovin, Chair of the Lupus Foundation of America’s Medical-Scientific Advisory Council and investigator in the REGENCY trial, shares what this milestone means for people with lupus.

