GAZYVA is the first and only FDA-approved treatment for adults with primary membranous nephropathy (MN) at risk of disease progression, to help achieve remission by reducing protein levels in the urine

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Primary membranous nephropathy, also known as MN, is an autoimmune kidney disease and a leading cause of nephrotic syndrome in adults. In most people with MN, certain immune cells produce harmful proteins called anti-PLA2R antibodies. These antibodies can damage the tiny filters in the kidneys and cause protein to leak into the urine. This is called proteinuria. Other signs may include swelling, low protein levels in the blood, high cholesterol, foamy urine, and changes in kidney function. Some people may improve without treatment, while others may experience worsening kidney function over time.

GAZYVA® (obinutuzumab) is a prescription medicine used to treat adults with primary membranous nephropathy (MN) at risk of disease progression, to help achieve remission by reducing protein levels in the urine. GAZYVA is a monoclonal antibody designed to find and attach to CD20, a protein found on certain B cells. B cells are part of the immune system. In MN, some B cells produce harmful anti-PLA2R antibodies that can damage the kidney filters. Based on laboratory studies, GAZYVA targets and destroys these B cells more effectively than similar anti-CD20 monoclonal antibodies.

MAJESTY was a Phase III clinical study that compared GAZYVA with tacrolimus in adults with biopsy-confirmed MN. Participants continued to have too much protein in their urine despite receiving supportive care. The main goal was complete remission of proteinuria at Week 104. Complete remission meant that protein levels in the urine were reduced to the study-defined level while kidney function remained stable.

GAZYVA is given as an intravenous, or IV, infusion according to the approved dosing schedule. Medicines are given before each infusion to help reduce the chance of infusion-related reactions. GAZYVA is administered by a healthcare professional in a setting equipped to manage serious reactions. Blood counts should be checked regularly.

GAZYVA carries Boxed Warnings for hepatitis B virus reactivation and progressive multifocal leukoencephalopathy, a rare but serious brain infection. Other serious risks include infusion-related reactions, allergic reactions, tumor lysis syndrome, serious and fatal infections, low white blood cell counts, low platelet counts, and a serious blood clotting disorder. Review the full Prescribing Information for complete dosing and safety information.