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GAZYVA is the first and only FDA-approved treatment for adult patients with primary membranous nephropathy (MN) at risk of disease progression, to induce remission of proteinuria1

GAZYVA is the first and only FDA-approved treatment for adult patients with primary membranous nephropathy (MN) at risk of disease progression, to induce remission of proteinuria1

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Genentech offers a variety of financial services, including a $0 Co-Pay Program for eligible, commercially insured patients.*†

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GAZYVA has an established J-code (J9301) and information to assist you in completing the payer forms for GAZYVA.

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COMPLETE REMISSION

Primary endpoint1

36% vs 6% with tacrolimus achieved complete remission at 2 years‡

Treatment difference of 31% (95% CI, 18.2, 44.0; P<0.0001)

COMPLETE OR PARTIAL

Secondary endpoint1

50% vs 13% with tacrolimus achieved complete or partial remission at 2 years§

Treatment difference of 37.8% (95% CI, 23.9, 51.8; P<0.0001)

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*The Co-pay Program (“Program”) is valid ONLY for patients with commercial (private or non-governmental) insurance who have a valid prescription for a Food and Drug Administration (FDA)-approved indication of a Genentech medicine. The Program is not available to patients whose prescriptions are reimbursed under any federal, state, or government-funded insurance programs (included but not limited to Medicare, Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs Programs) or where prohibited by law or by the patient's health insurance provider. If at any time a patient begins receiving prescription drug coverage under any such federal, state or government-funded healthcare programs, the patient will no longer be eligible for the Program.

Under the Program, the patient may be required to pay a co-pay. The final amount owed by a patient may be as little as $0 for the Genentech medicine (see Program specific details available at the Program website). The total patient out-of-pocket cost is dependent on the patient’s health insurance plan. The Program assists with the cost of the Genentech medicine only. It does not assist with the cost of other medicines, procedures or office visit fees. After reaching the maximum annual Program benefit amount, the patient will be responsible for all remaining out-of-pocket expenses. The Program benefit amount cannot exceed the patient’s out-of-pocket expenses for the Genentech medicine.

All participants are responsible for reporting the receipt of all Program benefits as required by any insurer or by law. The Program is only valid in the United States and U.S. Territories, is void where prohibited by law and shall follow state restrictions in relation to AB-rated generic equivalents (e.g., MA, CA) where applicable. No party may seek reimbursement for all or any part of the benefit received through the Program. The value of the Program is intended exclusively for the benefit of the patient. The funds made available through the Program may only be used to reduce the out-of-pocket costs for the patient enrolled in the Program. The Program is not intended for the benefit of third parties, including without limitation third party payers, pharmacy benefit managers, or their agents. If Genentech determines that a third party has implemented a program that adjusts patient cost-sharing obligations based on the availability of support under the Program and/or excludes the assistance provided under the Program from counting towards the patient’s deductible or out-of-pocket cost limitations, Genentech may impose a per fill cap on the cost-sharing assistance available under the Program. Submission of true and accurate information is a requirement for eligibility and Genentech reserves the right to disqualify patients who do not comply with Genentech Program Terms and Conditions. Genentech reserves the right to rescind, revoke or amend the Program without notice at any time.

Additional terms and conditions apply. Please visit the Co-pay Program website for the full list of Terms and Conditions.

†Genentech provides coverage and reimbursement services to patients to help them understand benefits, coverage, and reimbursement. Genentech provides these services to patients only after a healthcare provider has prescribed a Genentech product.
‡Complete remission at Week 104, defined as UPCR ≤0.3 g/g (24-hr collection) with a stable eGFR (≥85% of baseline), and no intercurrent events (escape therapy, treatment failure, or early study withdrawal).1,2​
§Partial remission is defined as ≥50% reduction in UPCR vs baseline, UPCR >0.3 to ≤3.5 g/g, with a stable eGFR (≥85% of baseline), and no intercurrent events (escape therapy, treatment failure, or early study withdrawal).1,2​
CI=confidence interval; eGFR=estimated glomerular filtration rate; UPCR=urine protein-to-creatinine ratio.

Primary membranous nephropathy, also known as MN, is an autoimmune glomerular disease and a leading cause of nephrotic syndrome in adults. In most cases, dysregulated B cells produce anti-phospholipase A2 receptor, or anti-PLA2R, antibodies. This can lead to immune complex deposits that disrupt the kidney’s filtration barrier and cause proteinuria, hypoalbuminemia, edema, and hyperlipidemia. The clinical course may range from spontaneous remission to progressive kidney function decline.

GAZYVA® (obinutuzumab) is indicated for the treatment of adult patients with primary membranous nephropathy at risk of disease progression, to induce remission of proteinuria. GAZYVA is a type II, humanized anti-CD20 monoclonal antibody designed to bind to CD20 on pre-B and mature B lymphocytes. It is engineered for higher Fc gamma receptor III binding affinity. Based on preclinical data, GAZYVA induces greater direct B-cell death, antibody-dependent cellular cytotoxicity, and antibody-dependent cellular phagocytosis compared with type I anti-CD20 antibodies.

MAJESTY was a Phase III, randomized, controlled, open-label, multicenter study evaluating GAZYVA versus tacrolimus in adults with biopsy-confirmed MN and persistent proteinuria despite best supportive care. The primary endpoint was complete remission of proteinuria while maintaining kidney function at Week 104, defined as UPCR ≤0.3 g/g (24-hr collection) with a stable eGFR (≥85% of baseline), and no intercurrent events (escape therapy, treatment failure, or early study withdrawal).

GAZYVA is administered as an intravenous infusion according to the approved dosing schedule. Premedication is required before each infusion. GAZYVA should be administered by a healthcare professional with appropriate medical support to manage severe infusion-related reactions. Blood counts should be monitored regularly.

GAZYVA carries Boxed Warnings for hepatitis B virus reactivation and progressive multifocal leukoencephalopathy. Additional risks include infusion-related reactions, hypersensitivity reactions, tumor lysis syndrome, serious and fatal infections, neutropenia, thrombocytopenia, and disseminated intravascular coagulation. Refer to the full Prescribing Information for complete dosing and safety information.

Important Safety Information and Indications

Indication

GAZYVA® (obinutuzumab) is indicated for the treatment of adult patients with primary membranous nephropathy (MN) at risk of disease progression, to induce remission of proteinuria.

BOXED WARNINGS: 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
  • Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving GAZYVA

Contraindications

  • GAZYVA is contraindicated in patients with known hypersensitivity reactions (eg, anaphylaxis) to obinutuzumab or to any of the excipients, or serum sickness with prior obinutuzumab use

Warnings and Precautions

Hepatitis B Virus Reactivation
  • GAZYVA can cause hepatitis B virus (HBV) reactivation. HBV reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with anti-CD20 antibodies, including GAZYVA. HBV reactivation has been reported in patients who are hepatitis B surface antigen (HBsAg) positive and in patients who are HBsAg negative but are hepatitis B core antibody (anti-HBc) positive. Reactivation has also occurred in patients who appear to have resolved hepatitis B infection (ie, HBsAg negative, anti-HBc positive, and hepatitis B surface antibody [anti-HBs] positive)
  • HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level, or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive. Reactivation of HBV replication is often followed by hepatitis, ie, increase in transaminase levels and in severe cases, increase in bilirubin levels, liver failure, and death
  • Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with GAZYVA. For patients who show evidence of hepatitis B infection (HBsAg positive [regardless of antibody status] or HBsAg negative but anti-HBc positive), consult healthcare providers with expertise in managing hepatitis B regarding monitoring and consideration for HBV antiviral therapy
  • Monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following treatment with GAZYVA
  • In patients who develop reactivation of HBV while receiving GAZYVA, immediately discontinue GAZYVA and any concomitant chemotherapy and institute appropriate treatment. Resumption of GAZYVA in patients whose HBV reactivation resolves should be discussed with healthcare providers with expertise in managing hepatitis B. Insufficient data exist regarding the safety of resuming GAZYVA in patients who develop HBV reactivation
Progressive Multifocal Leukoencephalopathy (PML)
  • John Cunningham (JC) virus infection resulting in PML, which can be fatal, occurred in patients treated with GAZYVA in chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL). Consider the diagnosis of PML in any patient presenting with new onset or changes to preexisting neurologic manifestations. Evaluation of PML includes, but is not limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Discontinue GAZYVA therapy and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML
Infusion-Related Reactions
  • GAZYVA can cause severe and life-threatening infusion-related reactions (IRRs)
  • In patients with MN, IRR onset and symptoms were generally similar to those observed in other indications. IRRs were generally mild to moderate in severity and could be managed by slowing or temporarily halting the infusion. Severe IRRs requiring treatment were also reported. The most common IRR signs or symptoms reported in the MAJESTY study were pyrexia, chills, hypotension, cough, dyspnea, nausea, and dizziness
  • Premedicate patients with acetaminophen, an antihistamine, and a glucocorticoid. Closely monitor patients during the entire infusion. Reduce infusion rate, interrupt infusion, or permanently discontinue GAZYVA for IRRs based on severity. Institute medical management (eg, glucocorticoids, epinephrine, bronchodilators, and/or oxygen) for IRRs as needed
  • For patients with preexisting cardiac or pulmonary conditions, monitor more frequently throughout the infusion and the post-infusion period, since they may be at greater risk of experiencing more severe reactions. Hypotension may occur as part of the IRR to GAZYVA. Consider withholding antihypertensive treatments for 12 hours prior to, during each GAZYVA infusion, and for the first hour after administration until blood pressure is stable. For patients at increased risk of hypertensive crisis, consider the benefits versus the risks of withholding their antihypertensive medication
Hypersensitivity Reactions Including Serum Sickness
  • Hypersensitivity reactions have been reported in patients treated with GAZYVA. Signs of immediate-onset hypersensitivity included dyspnea, bronchospasm, hypotension, urticaria, and tachycardia. Late-onset hypersensitivity diagnosed as serum sickness has also been reported, with symptoms that include chest pain, diffuse arthralgia, and fever. Hypersensitivity reactions may be difficult to clinically distinguish from IRRs. However, hypersensitivity very rarely occurs with the first infusion and, when observed, often occurs after previous exposure
  • If a hypersensitivity reaction is suspected during or after an infusion, stop the infusion and permanently discontinue treatment. GAZYVA is contraindicated in patients with known hypersensitivity reactions to GAZYVA, including serum sickness with prior GAZYVA use
Serious, Including Fatal, Infections
  • Fatal and serious bacterial, fungal, and new or reactivated viral infections can occur during and following GAZYVA therapy
  • In the main study period of MAJESTY, the incidence of Grade 3 (severe or medically significant) infections was 4% (3/71) in patients treated with GAZYVA compared to 3% (2/70) in the tacrolimus arm. No Grade 4 or Grade 5 (life-threatening or fatal) infections were reported in either arm
  • Do not administer GAZYVA to patients with an active infection. Patients with a history of recurring or chronic infections may be at increased risk of infection. In patients who develop a serious infection while receiving GAZYVA, immediately discontinue GAZYVA and institute appropriate treatment. Consider the risk and benefit of resuming treatment with GAZYVA following resolution of serious infections
Neutropenia
  • Severe and life-threatening neutropenia, including febrile neutropenia, has been reported during treatment with GAZYVA. Monitor patients with Grade 3 to 4 neutropenia frequently with regular laboratory tests until resolution. Anticipate, evaluate, and treat any symptoms or signs of developing infection. Consider dose delays for Grade 3 or 4 neutropenia. Consider administration of granulocyte colony-stimulating factors (GCSFs) in patients with Grade 3 or 4 neutropenia
  • Neutropenia can also be of late onset (occurring more than 28 days after completion of treatment) and/or prolonged (lasting longer than 28 days)
  • Patients with severe and long-lasting (>1 week) neutropenia are strongly recommended to receive antimicrobial prophylaxis until resolution of neutropenia to Grade 1 or 2. Consider antiviral and antifungal prophylaxis
Thrombocytopenia
  • Severe and life-threatening thrombocytopenia has been reported during treatment with GAZYVA in combination with chemotherapy. Fatal hemorrhagic events have been reported in patients with CLL treated with GAZYVA in combination with chemotherapy
  • Monitor patients frequently for thrombocytopenia and hemorrhagic events, and if clinically indicated, evaluate laboratory coagulation parameters. In patients with Grade 3 or 4 thrombocytopenia, monitor platelet counts more frequently until resolution and consider dose delays of GAZYVA and chemotherapy or dose reductions of chemotherapy. Transfusion of blood products (ie, platelet transfusion) may be necessary. Consider withholding concomitant medications that may increase bleeding risk (platelet inhibitors or anticoagulants), especially during the first cycle
Disseminated Intravascular Coagulation (DIC)
  • Fatal and severe DIC has been reported in patients receiving GAZYVA for CLL and NHL. The majority of DIC cases have involved changes in platelets and laboratory coagulation parameters following the first infusion, with spontaneous resolution usually occurring by Day 8. In some cases, DIC was associated with IRRs
  • In patients with suspected DIC, evaluate potential causes and monitor coagulation parameters, platelet counts, and for signs and symptoms of bleeding or thrombosis. Manage according to standard guidelines for DIC. Supportive care, including transfusion of blood products and other medical management, may be necessary
Immunization
  • The safety and efficacy of immunization with live or attenuated viral vaccines during or following GAZYVA therapy have not been studied. Immunization with live virus vaccines is not recommended during treatment with GAZYVA and until B-cell recovery
Embryo-Fetal Toxicity
  • Based on its mechanism of action and findings in animals, GAZYVA can cause B-cell depletion in infants exposed to obinutuzumab in utero. Advise pregnant women of the potential risk to the fetus. Mothers who have been exposed to GAZYVA during pregnancy should discuss the safety and timing of live virus vaccinations for their infants with their child’s healthcare providers. Advise females of reproductive potential to use effective contraception while receiving GAZYVA and for 6 months after the last dose
Lactation
  • Human IgG is known to be present in human milk. Because of the potential of serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with GAZYVA and for 6 months after the last dose
Additional Important Safety Information
  • The most common adverse reactions (incidence ≥3%) observed in patients with MN in the GAZYVA arm were infusion-related reactions and upper respiratory tract infection

You are encouraged to report side effects to Genentech and the FDA. You may contact Genentech by calling 1-888-835-2555. You may contact the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Please see the full Prescribing Information for additional Important Safety Information, including BOXED WARNINGS.

    • GAZYVA full Prescribing Information. Genentech, Inc.; 2026.

      GAZYVA full Prescribing Information. Genentech, Inc.; 2026.

    • Fervenza FC, Hou FF, Hao CM, et al. Obinutuzumab or tacrolimus in primary membranous nephropathy. N Engl J Med. Published online June 5, 2026. doi:10.1056/NEJMoa2602678

      Fervenza FC, Hou FF, Hao CM, et al. Obinutuzumab or tacrolimus in primary membranous nephropathy. N Engl J Med. Published online June 5, 2026. doi:10.1056/NEJMoa2602678

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