Gazyva (Obinutuzumab) for Lupus

Gazyva (obinutuzumab) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat adults with active lupus nephritis.

How Gazyva Works and How It’s Taken

Gazyva is a monoclonal antibody, a type of medicine that targets a specific protein. It targets CD20, a protein found on certain B cells. When Gazyva attaches to CD20, it helps destroy these B cells.

In lupus nephritis, reducing B cells helps lower immune system activity that can damage the kidneys.

Doctors prescribe Gazyva when adults have active lupus nephritis and are also receiving standard therapy.

Gazyva is given as an intravenous (IV) infusion. A healthcare professional should give it in a setting with medical support available to manage severe infusion-related reactions.

Typical Dosing for Lupus Nephritis

The recommended dose of Gazyva for lupus nephritis is 1,000 milligrams by IV infusion:

Dose 1 — Initial infusion
Dose 2 — week 2
Dose 3 — week 24
Dose 4 — week 26
Dose 5 and later doses — Every six months

Dose 5 is given six months after dose 4.

People receive medicines before each infusion to help reduce infusion-related reactions. If a reaction happens, the healthcare professional may slow or stop the infusion. Severe reactions may require Gazyva treatment to be stopped permanently.

This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

Gazyva Side Effects

In clinical studies of adults with active lupus nephritis who were receiving standard therapy, the most common side effects occurred in about 10 percent to 29 percent of people. These included:

Upper respiratory tract infection (such as a cold)
COVID-19
Urinary tract infection
Bronchitis
Pneumonia
Infusion-related reactions (reactions during or within 24 hours after an infusion)
Neutropenia (low neutrophils, a type of white blood cell)

Serious Side Effects and Warnings

Gazyva can cause serious side effects that may require immediate medical attention. These include:

Hepatitis B virus reactivation — The virus can become active again and cause severe liver problems, including liver failure.
Progressive multifocal leukoencephalopathy (PML) — This rare, serious brain infection caused by JC virus can be fatal.
Serious infections — Severe bacterial, fungal, or viral infections can occur, including new or reactivated infections.
Severe infusion-related reactions — These reactions can be life-threatening and may include trouble breathing, a fast heartbeat, or low blood pressure.
Hypersensitivity reactions, including serum sickness — This immune reaction can cause symptoms such as joint pain, fever, and swelling.
Neutropenia — Dangerously low neutrophil levels can raise the risk of serious infection, including febrile neutropenia.
Thrombocytopenia — Low platelet levels can increase the risk of serious bleeding.
Disseminated intravascular coagulation (DIC) — This serious blood-clotting problem can cause both clotting and bleeding.

Get medical help right away if you think you are having a serious reaction.

How To Save on Gazyva

The Gazyva website offers the Gazyva Immunology Co-Pay Program. Eligible people with commercial insurance may pay as little as $0 per treatment. The program is not available to people enrolled in federal or state-funded health insurance programs.

The website also provides information about other financial assistance options for people with government insurance or no insurance. It offers help understanding insurance coverage and out-of-pocket costs, exploring affordability options, and finding treatment resources.

To learn more, visit the Gazyva financial assistance page or call 877-436-3683.

What To Know Before Taking Gazyva

Before starting Gazyva, your doctor will test you for hepatitis B infection.

Live virus vaccines are not recommended during Gazyva treatment or until your B cells recover.

Tell your doctor if you have any allergies to obinutuzumab or any ingredients in Gazyva.

Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.

Also tell your doctor if you have an active infection or a history of infections that keep coming back or last a long time.

Do not receive Gazyva if you have had a serious allergic reaction, such as anaphylaxis, to obinutuzumab or any ingredient in Gazyva. You also should not receive it if you had serum sickness after using obinutuzumab before.

Gazyva is also FDA-approved to treat chronic lymphocytic leukemia (CLL) and certain types of follicular lymphoma (FL).

If you miss a planned dose, it should be given as soon as possible. Do not wait for the next planned dose. Your care team will adjust the schedule to keep the correct time between doses.

Tell your doctor if you are pregnant or plan to become pregnant. Gazyva can harm your baby if you are pregnant. Use effective birth control during treatment and for six months after your last dose.

Do not breastfeed during treatment with Gazyva or for six months after your last dose.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Gazyva for lupus nephritis?

In a 76-week study of adults with active lupus nephritis who were receiving standard therapy, 46.4 percent of people taking Gazyva had a complete renal response. This occurred in 33.1 percent of people taking placebo (an inactive treatment). A complete renal response meant that kidney function and urine protein levels met the study’s goals, without treatment failure, rescue treatment, death, or leaving the study early.

A renal-related event or death occurred in 17.8 percent of people taking Gazyva and 33.8 percent of people taking placebo.

How long does Gazyva take to work for lupus nephritis?

Gazyva may begin changing certain immune markers within the first few weeks. However, the clinical study did not show exactly when symptoms or kidney function may improve. In the main study, treatment effectiveness was measured at week 76.

Are any medications given before a Gazyva infusion?

Yes. Before each Gazyva infusion for lupus nephritis, people receive medicines to help lower the risk of an infusion-related reaction. These may include:

80 milligrams of methylprednisolone given through a vein
650 milligrams to 1,000 milligrams of acetaminophen
An antihistamine, such as 50 milligrams of diphenhydramine

These medicines are given shortly before the infusion. Starting with dose 6, the intravenous corticosteroid is given only to people who had an infusion-related reaction during the previous infusion.