Rituxan FAQs

Q & A

Q. What is Rituxan?
A.

Rituxan® (rituximab) in combination with glucocorticoids is used as an induction therapy to treat adults with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA). People with serious infections should not receive Rituxan. It is not known if Rituxan is safe or effective in children.

Rituxan in combination with glucocorticoids is the only FDA-approved induction therapy for adults with GPA and MPA.

Q. Who is Rituxan for?
A. Rituxan in combination with glucocorticoids is used as an induction therapy to treat 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. Has Rituxan been proven effective?
A.

Rituxan, in combination with glucocorticoids, may help put GPA and MPA into complete remission.

The Rituximab in ANCA-Associated Vasculitis (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 worked as well as cyclophosphamide (control group) in bringing on complete remission* 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, 38% of people in the Rituxan group maintained complete remission at 18 months following the single course of Rituxan; and 31% of those taking cyclophosphamide followed by azathioprine maintained complete remission at 18 months. The study also showed that there were no major differences between the overall side effects of Rituxan and cyclophosphamide followed by azathioprine. Talk to your doctor to learn more about these results and if Rituxan may be right for you.

*In a clinical trial for Rituxan, "complete remission" was defined as no disease activity and being able to stop steroids.

Q. How is Rituxan thought to work?
A.

Antibodies are produced by the immune system. Their job is to fight germs. But in GPA and MPA something goes wrong. Harmful antibodies called autoantibodies (pronounced aw-toh-AN-ti-bod-ees) are produced. The autoantibody often involved in GPA and MPA is known as ANCA. ANCAs attack healthy tissue and cells. 

ANCAs are produced by B-cells. They target a certain type of white blood cell called neutrophils (pronounced NOO-truh-fils). ANCAs cause the neutrophils to stick and clump to the walls of small blood vessels in different tissues and organs of the body. This process leads to inflammation. 

Rituxan decreases the number of B-cells by targeting those that have a specific marker on their cell surface called CD20. Because it is thought to interfere with B-cell function and disrupt ANCA production, Rituxan works differently from other medications used to treat GPA and MPA. 

Because Rituxan affects your immune system, it can increase your chances of getting serious infections. These serious infections can happen during and after treatment with Rituxan, and can be fatal. Rituxan can lower the ability of your immune system to fight infections. Types of serious infections that can happen with Rituxan include bacterial, fungal, and viral infections. After receiving Rituxan, some patients have developed low levels of certain antibodies in their blood for a long period of time (longer than 11 months). Some of these patients with low antibody levels developed infections. Call your doctor right away if you have any symptoms of infection:

  • fever    
  • cold symptoms, such as runny nose or sore throat that do not go away    
  • flu symptoms, such as cough, tiredness, and body aches   
  • earache or headache    
  • pain during urination    
  • white patches in the mouth or throat    
  • cuts, scrapes, or incisions that are red, warm, swollen, or painful
Q. When, where, and how is Rituxan given?
A.

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

  • Rituxan should only be administered by a healthcare professional with appropriate medical support to manage severe infusion reactions that can be fatal if they occur
  • If you have an infusion reaction, the infusion is slowed or stopped to help manage it
  • Rituxan infusions can result in some serious, sometimes life-threatening side effects
  • Infusion reactions with Rituxan may include fever, chills and shakes, itching, and coughing. If you experience any type of reaction, be sure to talk with your doctor.
  • Before each infusion, be sure to review the Rituxan Medication Guide and discuss it with your doctor
  • Rituxan can lower certain blood cell counts. Your doctor may do blood tests during treatment with Rituxan to check your blood cell counts. Be sure to schedule any visits that require lab tests
Q. How should I prepare for my Rituxan infusions?
A.

A Rituxan infusion may last several hours, so you may want to bring along a book or some music to help pass the time. Also, it may be a good idea to bring along some food in case you get hungry. Just check that the facility where you are receiving your infusion allows you to bring your own food.

Before every infusion, be sure to review the Medication Guide that accompanies the full Prescribing Information with your healthcare provider.

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

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take or have taken:

  • a Tumor Necrosis Factor (TNF) inhibitor medicine    
  • a Disease Modifying Anti-Rheumatic Drug (DMARD)

If you are not sure if your medicine is one listed above, ask your doctor or pharmacist. 

Know the medicines you take. Keep a list of them to show to your doctor and pharmacist when you get a new medicine. Do not take any new medicine without talking with your doctor.

Q. What should I know about side effects with Rituxan?
A.

Rituxan can cause serious side effects that can lead to death, including:

  • Infusion Reactions: Infusion reactions are the most common side effect of Rituxan treatment. Serious infusion reactions can happen during your infusion or within 24 hours after your infusion
  • Severe Skin and Mouth Reactions: 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
  • Progressive Multifocal Leukoencephalopathy (PML): a rare, serious brain infection caused by the JC virus

What should I tell my doctor before receiving Rituxan?

Before receiving Rituxan, tell your doctor if you:

  • Have had a severe infusion reaction to Rituxan in the past
  • Have a history of other medical conditions including:
    • Heart problems
    • Irregular heartbeat
    • Chest pain
    • Lung or kidney problems
  • Have had an infection, currently have an infection, or have a weakened immune system
  • Have recently been given a vaccine, plan to get a vaccine, or are in contact with someone who is planning to get a vaccine. You should not get certain vaccines before or after receiving Rituxan. Some types of vaccines can spread to people with a weakened immune system and cause serious problems
  • Have taken Rituxan in the past
  • Have any other medical conditions
  • Are pregnant or planning to become pregnant. Talk to your doctor about effective birth control
  • Are breast-feeding or plan to breast-feed
  • Are taking any medications, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take or have taken:
    • A Tumor Necrosis Factor (TNF) inhibitor medicine
    • A Disease Modifying Anti-Rheumatic Drug (DMARD)

What are the possible side effects of Rituxan?

Rituxan can cause serious and life‐threatening 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 may cause an abnormal heart rhythm
  • Serious Infections: Serious infections can happen during and after treatment with Rituxan and can lead to death
  • Heart Problems: Rituxan may cause chest pain and irregular heartbeats, which may need treatment, or your doctor may decide to stop your treatment with Rituxan
  • Kidney Problems: especially if you are receiving Rituxan for NHL. Your doctor should do blood tests to check how well your kidneys are working
  • Stomach and Serious Bowel Problems That Can Sometimes Lead to Death: Tell your doctor right away if you have any stomach area pain during treatment with Rituxan
  • Low Blood Cell Counts: Your doctor may do blood tests during treatment with Rituxan to check your blood cell counts

What are common side effects during treatment with Rituxan?

  • Infusion reactions
  • Chills
  • Infections
  • Body aches
  • Tiredness
  • Low white blood cell counts

Other side effects include:

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

Tell your doctor or healthcare team about any side effect that bothers you or does not go away.

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at (800) FDA‐1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835‐2555.

Please see the Rituxan 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.