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GAZYVA guide

Use this guide to learn about MN, GAZYVA, and what to expect from treatment.

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Financial support

Genentech offers a variety of services to support treatment, including a $0 Co-pay Program for eligible, commercially insured patients, with assistance from a live Case Manager.*

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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.

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.

Important Safety Information and Indication

Indication

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.

What is the most important safety information I should know about GAZYVA?

Tell your doctor right away about any side effects you experience. GAZYVA can cause side effects that may lead to death, including:

  • Hepatitis B Virus (HBV) Reactivation: If you've had hepatitis B, the virus can become active again while you're on GAZYVA. This can cause severe liver problems, including liver failure and death. Your doctor or healthcare team will need to screen you for hepatitis B before, and monitor you during and after, your treatment with GAZYVA. Symptoms of hepatitis B include worsening of fatigue and yellow discoloration of skin or eyes
  • Progressive Multifocal Leukoencephalopathy (PML): PML is a rare, severe infection of the brain that can lead to death. Symptoms of PML include confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems
Who should not receive GAZYVA?
  • Do NOT receive GAZYVA if you have had an allergic reaction (eg, anaphylaxis or serum sickness) to GAZYVA. Tell your healthcare provider if you have had an allergic reaction to obinutuzumab or any of its ingredients in the past
What are additional possible serious side effects of GAZYVA?

GAZYVA can cause side effects that may become severe or life-threatening including:

  • Infusion-Related Reactions (IRRs): Symptoms of IRRs may include headache, nausea, vomiting, fever, and fast heartbeat. Your doctor will monitor you for infusion-related reactions
  • Hypersensitivity Reactions, Including Serum Sickness: Some people receiving GAZYVA may have serious allergic reactions during or after an infusion. If an allergic reaction occurs, your doctor will stop the infusion and permanently discontinue GAZYVA
  • Serious, including fatal, Infections: Fatal and serious infections can occur during or after treatment with Gazyva. Patients with an active infection should not be treated with GAZYVA. If you develop a serious infection, your doctor will immediately discontinue GAZYVA and begin treatment for the infection
  • Low White Blood Cell Counts: Low white blood cell count can increase the risk of infection. While taking GAZYVA, your doctor will do blood work to check your white blood cell count. Your doctor may prescribe medication to help prevent infections if your white blood cell count is low
  • Low Platelet Counts: Platelets help stop bleeding or blood loss. GAZYVA with chemotherapy may reduce the number of platelets you have in your blood. If your platelet count gets too low, your treatment may be delayed or reduced
  • Disseminated Intravascular Coagulation (DIC): Fatal and severe DIC has been reported in people receiving GAZYVA for chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL). DIC is a rare and serious abnormal blood clotting condition that should be monitored and managed by your doctor, as it can lead to uncontrollable bleeding

The most common side effects of GAZYVA in MN were infusion-related reactions and upper respiratory tract infection.

What other information should I tell my doctor before receiving GAZYVA?

You should talk to your doctor about:

  • Immunizations: People who are treated with GAZYVA should not receive live vaccines
  • Pregnancy: GAZYVA may harm your unborn baby. Women of childbearing potential should use effective contraception while taking GAZYVA and for 6 months after GAZYVA treatment
  • Breastfeeding: Women should not breastfeed while taking GAZYVA and for 6 months after your last dose

These are not all of the possible side effects of GAZYVA. For more information, ask your doctor or pharmacist.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see the full Prescribing Information for additional Important Safety Information, including Serious Side Effects.

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