Information for Healthcare Providers / Patients

Rituxan® (rituximab - Immunology)

• Full Prescribing Information including boxed WARNINGS
• Medication Guide

What it Treats

Rituxan® (Rituximab) in combination with methotrexate is indicated for the treatment of adult patients with moderately- to severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies. Rituxan with glucocorticoids is used to treat adults with Wegener's Granulomatosis (WG) and Microscopic Polyangiitis (MPA).

People with serious infections should not receive Rituxan.

Important Safety Information

• Rituxan can cause serious side effects that can lead to death, including: infusion reactions, tumor lysis syndrome (TLS; kidney failure due to fast breakdown of cancer cells), severe skin and mouth reactions, and progressive multifocal leukoencephalopathy (PML; a rare, serious brain infection).
• Infusion Reactions: Serious infusion reactions can happen during the infusion or within 24 hours of receiving Rituxan. The doctor should give the patient medicines before the infusion of Rituxan to decrease the patients' chance of having a severe infusion reaction. If a serious reaction occurs, the infusion may be stopped and the patient should receive medical care. Patients must tell their doctor or get medical help right away if they get any of these symptoms: hives or rash, itching, swelling of the lips, tongue, throat, or face, sudden cough, shortness of breath, difficulty breathing or wheezing, weakness, dizziness or feeling faint, palpitations, or chest pain.
• Tumor Lysis Sydrome (TLS): TLS is caused by the fast breakdown of cancer cells and can occur after treatment with Rituxan. TLS can cause a person to have kidney failure and the need for dialysis treatment. TLS may also cause abnormal heart rhythm. The doctor may give the patient medicines to prevent TLS and do blood tests to check the patient for TLS.
• Severe Skin and Mouth Reactions: Severe skin and mouth reactions can occur in patients who receive Rituxan.
• Progressive Multifocal Leukoencephalopathy (PML): PML is a rare, serious brain infection caused by a virus. People with a weakened immune system can get PML. Patients must tell their doctor right away if they have any of the following symptoms: confusion or problems thinking, loss of balance, change in the way they walk or talk, decreased strength or weakness on one side of their body, blurred vision or loss of vision.
• Other serious, potentially life-threatening side effects are: hepatitis B infection that may become active again, other infections, heart problems, and low blood cell counts.
• Common side effects during Rituxan infusions include fever, headache, chills and shakes, nausea, itching, hives, cough, sneezing, throat irritation or tightness.
• Other side effects with Rituxan include aching joints, upper respiratory tract infection, decreased blood cell counts, and lung problems.
• The most common side effects seen in patients with RA were upper respiratory tract infection, nasopharyngitis (nose and throat inflammation), urinary tract infection, and bronchitis.
• The most common side effects seen in patients with WG and MPA were infections, nausea, diarrhea, headache, muscle spasms, anemia, peripheral edema (swollen hands and feet).
• These are not all of the possible side effects with Rituxan. Patients should tell their doctor about any side effects that bother them or that do not go away.

Patients should read the Rituxan Full Prescribing Information including Boxed WARNINGS, and the Medication Guide at www.rituxan.com.