RA Support Center

Rituxan Safety Information

When considering a treatment, its safety profile is just as important as how well it works. To learn more about Rituxan safety, click here for the full prescribing information and read the medication guide before you start Rituxan and before each Rituxan infusion.

INDICATION STATEMENT

Rituxan^® (rituximab) in combination with methotrexate is indicated to reduce signs and symptoms and to slow the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis who have had inadequate response to one or more TNF antagonist therapies.

IMPORTANT SAFETY INFORMATION

Rituxan can cause serious side effects including:

Progressive Multifocal Leukoencephalopathy (PML)

• PML is a rare brain infection. PML usually causes death or severe disability.
• 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.
• PML usually happens in patients with weakened immune systems.
• PML can occur during treatment with Rituxan or after treatment has finished.
• There is no known treatment, prevention, or cure for PML.

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 types of cancer cells. TLS can cause kidney failure and the need for dialysis treatment. Patients receiving Rituxan for non-Hodgkin's lymphoma (NHL) may get TLS. Your doctor will check you for TLS.

Severe skin reactions. Tell your doctor or get medical treatment right away if you get any of these symptoms: painful sores on your skin or in your mouth, ulcers, blisters, or peeling skin while receiving or after receiving Rituxan.

Rituxan can cause other serious and life threatening side effects including:

Hepatitis B virus reactivation. Tell your doctor if you had Hepatitis B virus or are a carrier of Hepatitis B virus. Receiving Rituxan could cause the Hepatitis B virus to become an active infection again. This may cause serious liver problems and death. 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 cough that will not go away, 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 during Rituxan infusions include:

• fever
• chills and shakes
• itching
• cough
• throat irritation or tightness
• headache
• nausea
• hives
• sneezing

Other side effects with Rituxan include:

• aching joints
• upper respiratory tract infection
• decreased blood cell counts
• lung problems

Tell your doctor about any side effect that bothers you or that does not go away. These are not all of the possible side effects with Rituxan. Ask your doctor for more information.

Please see full prescribing information and the medication guide for additional important information.