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Glossary

    A
    Advanced therapy

    A therapy, like GAZYVA, added to standard therapy of an immunosuppressant and steroids for the treatment of lupus nephritis. An advanced therapy may also be referred to as triple therapy.

    Antibodies

    Proteins made by your immune system to fight infections. In lupus nephritis, your body makes harmful antibodies that attack your kidneys.

    B
    B cells

    A type of white blood cell. In lupus nephritis, B cells can create harmful antibodies. GAZYVA works by targeting and removing these B cells.

    C
    Chronic condition

    A long-term condition that does not have a cure. Lupus nephritis is a chronic condition.

    Complete renal response

    A sign that the kidneys are stable and there is no active inflammation. It means low levels of protein in the urine and maintaining kidney function.

    F
    Flares

    Times when lupus nephritis symptoms suddenly get worse. Flares can cause more damage to your kidneys.

    I
    Immunosuppressant

    A medicine that stops your immune system from attacking healthy cells and tissues by mistake.

    Infusion

    A way to get medicine through a vein (intravenous, or IV). GAZYVA is given as an infusion by a healthcare professional.

    Infusion-related reaction

    A side effect that can happen during or after an infusion. Symptoms may include chills, fever, nausea, rash, or shortness of breath.

    K
    Kidney failure

    A serious condition where the kidneys stop working. It may require dialysis or a transplant.

    Kidney remission

    Having low protein in the urine, maintaining kidney function, and showing no active signs of inflammation.

    L
    Lupus nephritis

    A type of kidney disease caused by lupus. The immune system attacks the kidneys, causing inflammation and damage.

    M
    Mycophenolate mofetil (MMF)

    A medicine used to treat lupus nephritis. It is often part of standard or advanced therapy.

    N
    Neutropenia

    Low white blood cell count. Neutropenia itself usually doesn’t cause symptoms, but it makes you more likely to get infections.

    P
    Proteinuria

    High levels of protein in the urine. This is a sign of kidney damage in lupus nephritis.

    S
    Side effects

    Unwanted symptoms or reactions from a treatment. Some side effects of GAZYVA may include infections, infusion-related reactions, or neutropenia.

    Standard therapy

    A treatment that uses 2 types of medicine, usually a steroid and an immunosuppressant like MMF (mycophenolate mofetil), to manage lupus nephritis.

    Steroids

    Medicines that reduce inflammation but can cause side effects when used in high doses for a long time.

    W
    White blood cells

    Cells that help fight infections. Some types, like B cells, are involved in lupus nephritis.

Important Safety Information and Indication

Indication

GAZYVA® (obinutuzumab) is a prescription medicine used to treat adult patients with active lupus nephritis (LN) who are receiving standard therapy.

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 can become serious or life-threatening, including:

  • Hepatitis B Virus (HBV): Hepatitis B can cause liver failure and death. If you have a history of hepatitis B infection, GAZYVA could cause it to return. You should not receive GAZYVA if you have active hepatitis B liver disease. Your doctor or healthcare team will need to screen you for hepatitis B before, and monitor you during and after, your treatment with GAZYVA. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis B include worsening of fatigue and yellow discoloration of skin or eyes

  • Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus. PML can be fatal. Your weakened immune system could put you at risk. Your doctor will watch for symptoms. 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 other ingredients in GAZYVA in the past

What are additional possible serious side effects of GAZYVA?

Tell your doctor right away about any side effects you experience. GAZYVA can cause side effects that may become severe or life-threatening, including:

  • Infusion-Related Reactions (IRRs): These side effects may occur during or within 24 hours of any GAZYVA infusion. Some IRRs can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening IRRs. If you have a reaction, the infusion is either slowed or stopped until your symptoms are resolved. Most patients are able to complete infusions and receive medication again. However, if the infusion-related reaction is life-threatening, the infusion of GAZYVA will be permanently stopped. Your healthcare team will take steps to help lessen any side effects you may have to the infusion process. You may be given medicines to take before each GAZYVA treatment. Symptoms of IRRs may include fast heartbeat, tiredness, dizziness, headache, redness of the face, nausea, chills, fever, vomiting, diarrhea, rash, high blood pressure, low blood pressure, difficulty breathing, and chest discomfort

  • Hypersensitivity Reactions, Including Serum Sickness: Some people receiving GAZYVA may have severe or life-threatening allergic reactions. This reaction may be severe, may happen during or after an infusion, and may affect many areas of the body. If an allergic reaction occurs, your doctor will stop the infusion and permanently discontinue GAZYVA

  • Serious, Including Fatal, Infections: While you’re taking GAZYVA, you may develop infections. Some of these infections can be fatal and severe, so be sure to talk to your doctor if you think you have an infection. Patients with a history of recurring or chronic infections may be at an increased risk of infection. Patients with an active infection should not be treated with GAZYVA. Patients taking GAZYVA plus standard therapy may be at higher risk for fatal or severe infections compared to patients taking standard therapy plus placebo. If you develop a serious infection, your doctor will immediately discontinue GAZYVA and begin treatment for the infection

  • Low White Blood Cell Count: When you have an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While you are taking GAZYVA, your doctor will do blood work to check your white blood cell count. Severe and life-threatening neutropenia can develop during or after treatment with GAZYVA. Some cases of neutropenia can last for more than one month. If your white blood cell count is low, your doctor may prescribe medication to help prevent infections

  • Low Platelet Count: Platelets help stop bleeding or blood loss. GAZYVA with chemotherapy may reduce the number of platelets you have in your blood; having low platelet count is called thrombocytopenia. This may affect the clotting process. While you are taking GAZYVA, your doctor will do blood work to check your platelet count. Severe and life-threatening thrombocytopenia can develop during treatment with GAZYVA. Fatal bleeding events have occurred in patients treated with GAZYVA. 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 LN were upper respiratory tract infection, COVID-19, urinary tract infection, bronchitis, pneumonia, infusion-related reactions, and neutropenia.

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

You should talk to your doctor about:

  • Immunizations: Before receiving GAZYVA therapy, tell your healthcare provider if you have recently received or are scheduled to receive a vaccine. People who are treated with GAZYVA should not receive live vaccines

  • Pregnancy: Tell your doctor if you are pregnant, think that you might be pregnant, or plan to become pregnant. GAZYVA may harm your unborn baby. Speak to your doctor about using GAZYVA while you are pregnant. Talk to your doctor or your child’s doctor about the safety and timing of live virus vaccinations to your infant if you received GAZYVA during pregnancy. Women of childbearing potential should use effective contraception while taking GAZYVA and for 6 months after GAZYVA treatment

  • Breastfeeding: Because of the potential risk of serious side effects in breastfed children, women should not breastfeed while taking GAZYVA and for 6 months after your last dose

Tell your doctor about any side effects.

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

GAZYVA is available by prescription only.

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.

  • Lupus nephritis

    A type of kidney disease caused by lupus. The immune system attacks the kidneys, causing inflammation and damage.

  • Mycophenolate mofetil (MMF)

    A medicine used to treat lupus nephritis. It is often part of standard or advanced therapy.

  • Standard therapy

    A treatment that uses 2 types of medicine, usually a steroid and an immunosuppressant like MMF (mycophenolate mofetil), to manage lupus nephritis.

  • Kidney remission

    Having low protein in the urine, maintaining kidney function, and showing no active signs of inflammation.

  • Steroids

    Medicines that reduce inflammation but can cause side effects when used in high doses for a long time