Side Effect Reporting

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.

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)

Limitations of Use: Rituxan is not recommended for use in patients with severe, active infections

BOXED WARNINGS and Additional Important Safety Information

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. Monitor patients closely. Discontinue Rituxan infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion reactions.

Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving Rituxan.

Hepatitis B Virus (HBV) Reactivation: HBV reactivation can occur in patients treated with Rituxan, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with Rituxan. Discontinue Rituxan and concomitant medications in the event of HBV reactivation.

Progressive Multifocal Leukoencephalopathy (PML): PML, including fatal PML, can occur in patients receiving Rituxan.

Warnings and Precautions

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

  • Tumor lysis syndrome (TLS): Administer aggressive intravenous hydration, anti-hyperuricemic agents, monitor renal function
  • Infections: Withhold Rituxan and institute appropriate anti-infective therapy
  • Cardiac arrhythmias and angina: Discontinue infusions in case of serious or life-threatening events
  • Bowel obstruction and perforation: Consider and evaluate for abdominal pain, vomiting, or related symptoms
  • Live virus vaccines: Do not administer live virus vaccines prior to or during Rituxan
  • Cytopenias: Monitor blood counts at regular intervals

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

Report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.

Please see the Rituxan Full Prescribing Information including Boxed WARNINGS, and the Medication Guide at www.rituxan.com.