Rituxan FAQs

Q & A

Q. What is Rituxan?

Rituxan, in combination with glucocorticoids, is the only FDA-approved treatment to get rid of symptoms and keep them from coming back in adults with GPA (Wegener’s granulomatosis) and MPA. People with serious infections should not receive Rituxan. It is not known if Rituxan is safe or effective in children.

Rituxan only targets a specific type of white blood cell found in the immune system. These cells are known as CD20+ B cells and are thought to be involved in GPA and MPA. Rituxan targets these cells and reduces their levels in the body.

Q. Who is Rituxan for?
A. Rituxan in combination with glucocorticoids is used as an induction treatment to get rid of symptoms and keep them from coming back in adults with GPA and MPA. People with serious infections should not receive Rituxan. It is not known if Rituxan is safe or effective in children.
Q. How can Rituxan help people get rid of their GPA or MPA symptoms?

The RAVE Trial was conducted by the National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network with support from Genentech and Biogen. The goal of the trial was to see if Rituxan, in combination with glucocorticoids, worked as well as cyclophosphamide (CYC) with azathioprine (AZA) (the control group) in bringing on complete remission at 6 months in adults with GPA and MPA.

The RAVE Trial showed that Rituxan worked as well as cyclophosphamide (64% vs 53%, respectively) to achieve complete remission at 6 months. Also in the study, there was no significant difference in the rates of remission at 6, 12, or 18 months for patients treated with Rituxan compared with patients who received CYC followed by AZA (38% for Rituxan group and 31% for the control group). The study also showed that there were no major differences between the overall side effects experienced by each group.

In this clinical trial, “complete remission” was defined as no disease activity and being able to stop steroids by 6 months. Individual results may vary for each patient.

Q. Can Rituxan keep your flares from coming back?

Rituxan has been studied in patients who have GPA or MPA but no symptoms.

In a study of 115 adults, about half were given a version of rituximab* approved in the European Union plus glucocorticoids. The other half were given a medicine called azathioprine plus short-term steroids. The goal of the study was to compare how well each treatment kept moderate and severe symptoms (flares) from coming back.

95% of the patients who took Rituxan plus glucocorticoids did not experience moderate or severe symptoms after 28 months, compared to 71% of patients who received a different medication plus glucocorticoids.

Q. How is Rituxan thought to work?

Rituxan selectively targets a specific type of white blood cell in the immune system. These cells are called B cells, and they are thought to be involved in GPA and MPA. It is important to note that Rituxan targets only certain B cells that have a marker on their surface called CD20.

Here is a diagram of the certain type of B cells targeted by Rituxan:

Q. How is Rituxan given to get rid of the symptoms of GPA and MPA?

Rituxan is given as an IV infusion once weekly for 4 weeks.  An IV infusion is given to you through a needle that’s placed in a vein.

Q. What can I expect with Rituxan infusions?

Your first Rituxan infusion may take 3 to 5 hours. The exact duration varies for each patient based on the Rituxan dose you receive.

The first Rituxan infusion is given at a slower rate than following infusions in order to closely monitor for the occurrence of any infusion reactions. Rituxan can cause serious, including fatal, infusion reactions. If symptoms do occur, they are more likely to happen during the first infusion than during following infusions.

To help manage reactions, the infusion is slowed or stopped. It is important that you inform your nurse or doctor if you experience any side effects after your Rituxan infusion.

Q. How is Rituxan given to keep flares or symptoms from coming back?

The dosing for Rituxan is slightly different if your GPA or MPA is under control. Your doctor may start by giving you two IV infusions, two weeks apart. After that, you will receive a single IV infusion every 6 months for as long as you and your doctor wish to continue.

Q. Can I take other medicines on the days of my Rituxan infusions?

Follow your doctor’s or nurse practitioner’s instructions about taking your medicines, including blood pressure medicine, before your infusion. Talk to your doctor or nurse practitioner about all of your medical conditions, all the medications you are taking, and any vaccinations you, or anyone in your household, have received or are scheduled to receive. Your doctor may prescribe premedications on the day of your infusion. Tell your doctor or nurse practitioner if you are pregnant, planning to become pregnant, or breast-feeding. Tell your doctor about all the medicines you take, or have taken, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take or have taken:

  • a TNF inhibitor medicine
  • a disease-modifying antirheumatic drug (DMARD)
Q. What should I know about side effects with Rituxan?

When starting a treatment, there are many important factors to understand, consider, and discuss with your doctor or nurse practitioner, including the potential risks and benefits. The FDA-approved Rituxan safety information includes the risk of some potentially serious and life-threatening side effects. With Rituxan, they include the following: 

  • Infusion Reactions: Infusion reactions are very common side effects of Rituxan treatment. Serious infusion reactions can happen during your infusion or within 24 hours after your infusion of Rituxan. Your healthcare provider should give you medicines before your infusion of Rituxan to decrease your chance of having a severe infusion reaction 
  • Severe Skin and Mouth Reactions: Tell your healthcare provider or get medical help right away if you get any of these symptoms at any time during your treatment with Rituxan: painful sores or ulcers on your skin, lips, or in your mouth; blisters; peeling skin; rash; or pustules 
  • Hepatitis B Virus (HBV) Reactivation: If you have had hepatitis B or are a carrier of hepatitis B virus, receiving Rituxan could cause the virus to become an active infection again. Hepatitis B reactivation may cause serious liver problems, including liver failure and death. You should not receive Rituxan if you have active hepatitis B liver disease. Your healthcare provider will monitor you for hepatitis B infection during and for several months after you stop receiving Rituxan 
  • Progressive Multifocal Leukoencephalopathy (PML): PML is a rare, serious brain infection caused by a virus that can happen in people who receive Rituxan. People with weakened immune systems can get PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML

What are the possible side effects of Rituxan?

Rituxan can cause serious side effects, including:

  • Tumor Lysis Syndrome (TLS): TLS is caused by the fast breakdown of cancer cells. TLS can cause you to have kidney failure and the need for dialysis treatment or an abnormal heart rhythm. TLS can happen within 12-24 hours after an infusion of Rituxan. Tell your healthcare provider right away if you have any of the following signs or symptoms of TLS: nausea, vomiting, diarrhea, or lack of energy
  • Serious Infections: Serious infections can happen during and after treatment with Rituxan and can lead to death. Rituxan can increase your risk of getting infections and can lower the ability of your immune system to fight infections. People with serious infections should not receive Rituxan
  • Heart Problems: Rituxan may cause chest pain, irregular heartbeats, and heart attack. Your healthcare provider may monitor your heart during and after treatment with Rituxan if you have symptoms of heart problems or have a history of heart problems. Tell your healthcare provider right away if you have chest pain or irregular heartbeats during treatment with Rituxan
  • Kidney Problems: especially if you are receiving Rituxan for non–Hodgkin’s lymphoma (NHL). Rituxan can cause severe kidney problems that lead to death. Your healthcare provider should do blood tests to check how well your kidneys are working 
  • Stomach and Serious Bowel Problems That Can Sometimes Lead to Death: Bowel problems, including blockage or tears in the bowel, can happen if you receive Rituxan with chemotherapy medicines. Tell your healthcare provider right away if you have any stomach-area pain during treatment with Rituxan

Your healthcare provider will stop treatment with Rituxan if you have severe, serious, or life-threatening side effects.

What are the most common side effects during treatment with Rituxan?

  • Infusion reactions 
  • Infections (may include fever, chills) 
  • Body aches 
  • Tiredness 
  • Nausea

In patients with GPA or MPA, the most common side effects of Rituxan also include:

  • Low white and red blood cells
  • Swelling 
  • Diarrhea 
  • Muscle spasms

Other side effects include:

  • Aching joints during or within hours of receiving an infusion
  • More frequent upper respiratory tract infections

These are not all of the possible side effects with Rituxan.

Call your healthcare provider for medical advice about side effects. 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 Rituxan Prescribing Information and Medication Guide including Most Serious Side Effects for additional Important Side Effect Information.

Q. Are there financial resources to help me get Rituxan therapy?
A. At Genentech, we develop medicines for serious or life-threatening medical conditions. We believe they should be accessible for the patients who need them. Find out about our different programs that may be able to help you get Rituxan treatment.
Q. Where can I learn more?
A. Your doctor is the single most important source of information available to you. If you are looking to learn more about GPA and MPA, you can also visit the Vasculitis Foundation website. The Vasculitis Foundation is a good source of information for people with all types of AAV.

*People who were treated with Rituxan were given a version approved in the European Union