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.
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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 and pediatric patients 2 years of age and older 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 (PV)
BOXED WARNINGS and Additional Important Safety Information
- Infusion-Related Reactions: Rituxan administration can result in serious, including fatal infusion-related 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-related 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 fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception
- Patients with RA should be closely observed for signs of infection if biologic agents and/or DMARDs other than methotrexate are used concomitantly
- The use of Rituxan in patients with RA who have not had prior inadequate response to one or more TNF antagonists is not recommended
- 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
- Most common adverse reactions in patients with RA were upper respiratory tract infection, nasopharyngitis, urinary tract infection, and bronchitis. Other important adverse reactions include infusion-related reactions, serious infections, and cardiovascular events
- Most common adverse reactions in patients with GPA & MPA were infections, nausea, diarrhea, headache, muscle spasms, anemia, and peripheral edema. Other important adverse reactions include infusion-related reactions
- Most common adverse reactions in patients with PV were infusion-related reactions and depression. Other important adverse reactions include infections
For additional Important Safety Information, please see the Rituxan full Prescribing Information, including BOXED WARNINGS.