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Understanding lupus nephritis

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What Is Lupus Nephritis?
How Is Lupus Nephritis Treated?
Phases of Lupus Nephritis

What is lupus nephritis?

Lupus nephritis is a serious kidney disease that can develop in people with lupus. Your immune system usually protects you from illness, including making antibodies, which are proteins that fight infections. When you have lupus nephritis, your immune system creates harmful antibodies that attack your kidneys. This makes it harder for your kidneys to do their job.

Your kidneys play an important role in your health. They filter waste and help regulate your blood pressure. When they’re under attack, they can’t work as well, and, over time, the damage can lead to kidney failure.

Lupus nephritis is a long-term (chronic) condition, meaning that there is no cure. However, treatments like GAZYVA may help keep your lupus nephritis under control.

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You may show the following signs and symptoms of lupus nephritis:

  • Swelling in feet, ankles, legs, hands, or face
  • Blood in the urine
  • High blood pressure
  • Foamy urine
  • Joint or muscle pain
  • Fever with no known cause
  • Rash
  • Significant fatigue

The phases of lupus nephritis you may experience

You might be diagnosed by a specialist, such as a rheumatologist or nephrologist.

You may not show symptoms of lupus nephritis, so you should discuss with your doctor if it is appropriate to have routine screening with blood or urine tests to detect early signs. If any of these tests show signs of kidney involvement, a kidney biopsy may also be done to ensure an accurate diagnosis.

Once diagnosed, your doctor will recommend a treatment.

You’ll have regular check-ups and lab tests to track how you’re responding to treatment. If it’s not working, your kidneys may slowly lose function and symptoms may worsen.

Lupus nephritis can flare up, caused by inflammation, which leads to worse kidney function.

If lupus nephritis isn’t controlled, it can cause permanent kidney damage. This can lead to chronic kidney disease (CKD)—your kidneys may stop filtering waste like they should.

In some cases, the kidney damage advances to end-stage kidney disease, where your kidneys fail completely.

Dialysis (an artificial therapy to filter blood) or kidney transplant may be necessary.

Treat early, treat strong—your kidneys depend on it.

The sooner you get treatment, the better chance you have of preventing irreversible kidney damage. Delayed care or missed doses can lead to serious damage—and even kidney failure.

When serious kidney damage happens, you may need treatments like dialysis (a machine that does the work of the kidneys) or a kidney transplant. That’s why acting early can make a big difference in protecting your kidneys.

How is lupus nephritis treated?

Here are some of the ways lupus nephritis might be treated:

  • Standard therapy: combines 2 medicines, steroids and an immunosuppressant, like mycophenolate mofetil (MMF)
  • Advanced therapy + standard therapy: Adds an advanced medicine, like GAZYVA, to standard therapy.

Feel confident that adding advanced therapy is backed by experts

In lupus nephritis, there are guidelines that help inform doctors’ decisions when choosing research-backed treatments aimed to help protect your kidneys and manage lupus nephritis effectively.

One of the guidelines for lupus nephritis recommends starting with advanced therapy plus standard therapy.

Research shows that relying only on standard therapy may not lead to the same improved outcomes seen when adding on advanced therapies.

The reality of health disparities in lupus nephritis

Navigating a lupus nephritis diagnosis is a journey, and having a full understanding of the factors that can affect your care is an important part of that journey.

Unfortunately, not everyone has the same experience in the healthcare system. Health outcomes can be different for people depending on their race, background, and income.

Research across many areas of medicine, including lupus nephritis, shows that people from diverse racial and ethnic backgrounds or with lower incomes sometimes face greater challenges and may have different health outcomes compared to White people or people with higher incomes.

This is especially relevant for lupus nephritis, a condition that is about twice as likely to affect Black, Hispanic, and Asian people. Knowing this can help you feel more confident in advocating for your own health and working with your care team to learn about the right treatment options for you.

You deserve a treatment that’s right for you—never hesitate to ask for it.

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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