Rituxan® (ri-tuk´-san)
(Rituximab)

Read this patient information leaflet when you have been prescribed Rituxan and each time you are scheduled to receive a Rituxan infusion. This information does not take the place of talking to your doctor about your medical condition or your treatment. Talk with your doctor if you have any questions about your treatment with Rituxan.

What is the most important safety information I should know about Rituxan?

Rituxan can cause the following serious side effects, some of which could be life-threatening:

• Infusion reactions. Tell your doctor or get medical treatment right away if you get hives, swelling, dizziness, blurred vision, drowsiness, headache, cough, wheezing, or have trouble breathing while receiving or after receiving Rituxan.
• Tumor Lysis Syndrome (TLS). TLS is caused by the fast breakdown of certain blood cancers. TLS can cause kidney failure and the need for dialysis treatment. Patients receiving Rituxan for non-Hodgkin's lymphoma may get TLS.
• Severe skin reactions. Tell your doctor or get medical treatment right away if you get painful sores, ulcers, blisters, or peeling skin while receiving or after receiving Rituxan.
• Progressive Multifocal Leukoencephalopathy (PML). PML is a rare brain infection that usually causes death or severe disability.
• PML has been reported in patients during or after their treatment with Rituxan.
• There is no known treatment, prevention, or cure for PML.
• Call your doctor right away if you notice any new or worsening medical problems, such as a new or sudden change in thinking, walking, strength, vision, or other problems that have lasted over several days.

Also, see “What are possible side-effects with Rituxan?” for other serious side effects, some of which could be life-threatening.

What is Rituxan?

Rituxan is a biologic medicine used in adults:

• alone or with other anti-cancer medicines to treat certain types of non-Hodgkin's lymphoma (NHL).
• with another medicine called methotrexate to reduce the signs and symptoms of Rheumatoid Arthritis (RA) after at least one other medicine called a tumor necrosis factor (TNF) inhibitor has been used and did not work well.

Rituxan has not been studied in children.

How does Rituxan work?

Rituxan works by getting rid of certain B-cells in the blood. B-cells are a type of white blood cell found in the blood. B-cells usually help the body fight infection. B-cells play an important role in diseases such as NHL and RA. Rituxan may also get rid of healthy B-cells and this can give you a higher chance for getting infections.

Who should not receive Rituxan?

Do not receive Rituxan if you ever had an allergic reaction to Rituxan.

What should I tell my doctor before treatment with Rituxan?

Tell your doctor about all of your medical conditions, including if you:

• have an infection or have an infection that will not go away or that keeps coming back.
• are scheduled to have surgery.
• have had hepatitis B virus infection or are a carrier of hepatitis B virus. Your doctor should check you closely for signs of a hepatitis infection during treatment with Rituxan and for several months after treatment ends.
• have any scheduled vaccinations. It is not known if Rituxan affects your ability to respond to vaccines.
• have heart or lung problems.
• are pregnant or planning to become pregnant. It is not known if Rituxan can harm your unborn baby.
• are breastfeeding. It is not known if Rituxan passes into human breast milk. You should not breastfeed while being treated with Rituxan.

Tell your doctor about all the other medicines you take, including prescription and nonprescription medicines, vitamins, or herbal supplements. If you have RA, tell your doctor if you are taking or took another biologic medicine called a TNF inhibitor or a DMARD (disease modifying anti-rheumatic drug).

How do I receive Rituxan?

• Rituxan is given through a needle placed in a vein (IV infusion), in your arm. Rituxan therapy is given in different ways for NHL and RA. Talk to your doctor about how you will receive Rituxan.
• Your doctor may prescribe other medicines before each infusion of Rituxan to prevent or reduce pain, or to reduce fever and allergic reactions.
• Your doctor should do regular blood tests to check for side effects or reactions to Rituxan.

What are possible side effects with Rituxan?

Rituxan can cause the following serious side effects, some of which could be life-threatening side effects, including (See “What is the most important safety information I should know about Rituxan?”)

• Infusion reactions
• Tumor Lysis Syndrome (TLS)
• Severe skin reactions
• Progressive Multifocal Leukoencephalopathy (PML)

Other serious side effects with Rituxan include:

• Hepatitis B virus reactivation. Tell your doctor if you had Hepatitis B virus or are a carrier of Hepatitis B virus. Rituxan may make you sick with Hepatitis B virus again and cause serious liver problems. People with active liver disease due to Hepatitis B should stop receiving Rituxan.
• Heart Problems. Tell your doctor about any heart problems you have including chest pain (angina) and irregular heart beats. Rituxan can cause chest pain and irregular heart beats which may require treatment.
• Infections. Rituxan can increase your chances for getting infections. Call your doctor right away if you have a persistent cough, fever, chills, congestion, or any flu-like symptoms while receiving Rituxan. These symptoms may be signs of a serious infection.
• Stomach and bowel problems. Serious stomach and bowel problems have been seen when Rituxan has been used with anti-cancer medicines in some patients with non-Hodgkin's lymphoma. Call your doctor right away if you have any stomach area pain during treatment with Rituxan.

Common side effects with Rituxan include:

Fever, chills, shakes, itching, hives, sneezing, swelling, throat irritation or tightness, and cough. These usually occur within 24 hours after the first infusion. Other common side effects include headache, nausea, upper respiratory tract infection, and aching joints. If you have any of these symptoms, tell your doctor or nurse.

What if I still have questions?

If you have any questions about Rituxan or your health, talk with your doctor. You can also visit the Rituxan internet sites at www.Rituxan.com or the companies' internet sites at www.Gene.com or www.Biogenidec.com or call 1-877-4-Rituxan (877-474-8892).

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