Information for Patients / Medical Professionals

Rituxan® (rituximab - Immunology)

• Full Prescribing Information including boxed WARNINGS
• Healthcare Provider Letters

  3 letters

  Rituxan and the treatment of SLE - Dec 2006 Rituxan and PML - Oct 2009 Rituxan and RA - Sept 2008

Indication

• Rituxan® (rituximab) in combination with methotrexate is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more TNF antagonist therapies
• Rituxan® (rituximab), in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA)
• Rituxan is not recommended for treatment of patients with severe, active infections

Important Safety Information and BOXED WARNINGS

Fatal Infusion Reactions: Rituxan administration can result in serious, including fatal infusion reactions. Deaths within 24 hours of Rituxan infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Carefully monitor patients during infusions. Discontinue Rituxan infusion and provide medical treatment for Grade 3 or 4 infusion reactions. Tumor Lysis Syndrome (TLS): Acute renal failure requiring dialysis with instances of fatal outcome can occur in the setting of TLS following treatment of non-Hodgkin’s lymphoma (NHL) patients with Rituxan monotherapy. Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions, can occur in patients receiving Rituxan. Progressive Multifocal Leukoencephalopathy (PML): JC virus infection resulting in PML and death can occur in patients receiving Rituxan.

Warnings and Precautions

Rituxan administration can also result in additional serious, including fatal, adverse reactions including:

• hepatitis B reactivation
• other infections including bacterial, fungal, and new or reactivated viral infections
• cardiovascular events

The safety of immunization with live viral vaccines following Rituxan therapy has not been studied and vaccination with live virus vaccines is not recommended. Obtain complete blood counts (CBC) and platelet counts at 2- to 4-month intervals during Rituxan therapy.

Rheumatoid Arthritis (RA)

• Patients should be closely observed for signs of infection if biologic agents and/or DMARDs other than methotrexate are used concomitantly
• Common adverse reactions (≥10%) in clinical trials: upper respiratory tract infection, nasopharyngitis, urinary tract infection, and bronchitis. Other important adverse reactions include infusion reactions, serious infections, and cardiovascular events

Granulomatosis With Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA)

• Use of concomitant immunosuppressants other than corticosteroids has not been studied in GPA or MPA patients exhibiting peripheral B-cell depletion following treatment with Rituxan. Observe patients with GPA and MPA closely for signs of infection if immunosuppressants other than corticosteroids are used concomitantly.
• The safety and efficacy of retreatment with Rituxan have not been established in patients with GPA and MPA.
• Common adverse reactions (≥15%) in the clinical study were infections, nausea, diarrhea, headache, muscle spasms, anemia, and peripheral edema. Other important adverse reactions include infusion reactions.

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.

For additional safety information, please see the Rituxan full prescribing information, including BOXED WARNINGS and Medication Guide at www.rituxan.com.