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)
  • Rituxan® (rituximab) is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris

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), 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. Rituxan is not recommended for use in patients with severe, active infections
  • Cardiovascular adverse reactions: Discontinue infusions in case of serious or life-threatening events
  • Renal toxicity: Discontinue in patients with rising serum creatinine or oliguria
  • Bowel obstruction and perforation: Consider and evaluate for abdominal pain, vomiting, or related symptoms
  • Immunizations: Live virus vaccinations prior to or during Rituxan treatment are not recommended
  • Embryo-Fetal toxicity: Can cause neonatal harm. Advise of potential risk to neonates and use of effective contraception
  • Concomitant Use with Other Biologic Agents and DMARDS other than Methotrexate in RA, GPA and MPA, PV: Observe patients closely for signs of infection if biologic agents and/or DMARDs are used concomitantly. Use of concomitant immunosuppressants other than corticosteroids has not been studied in GPA, MPA, or PV patients exhibiting peripheral B-cell depletion following treatment with Rituxan
  • Use in RA Patients Who Have Not Had Prior Inadequate Response to Tumor Necrosis Factor (TNF) Antagonists: The use of Rituxan in patients with RA who have not had prior inadequate response to one or more TNF antagonists is not recommended

Most Common Adverse Reactions

Rheumatoid Arthritis (RA)

Most common adverse reactions (≥10%) were 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)

Most common adverse reactions (≥15%) were infections, nausea, diarrhea, headache, muscle spasms, anemia, and peripheral edema. Other important adverse reactions include infusion reactions.

Pemphigus Vulgaris (PV)

Most common adverse reactions (≥15%) were infusion reactions and depression. Other important adverse reactions include infections.

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 Important Safety Information, please see the Rituxan full Prescribing Information, including BOXED WARNINGS.