The safety profile of Rituxan compared with cyclophosphamide over the 6-month RAVE Trial
- No significant difference in overall adverse events occurred between treatment arms1
Rituxan is a Category C drug. There are no adequate and well-controlled studies of rituximab in pregnant women. Rituximab should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
Individuals of childbearing potential should use effective contraception during treatment and for 12 months after Rituxan therapy.
- *
- The study design allowed for crossover or treatment by best medical judgment.2
- †
- Infusion-related reactions reported in the Rituxan group included cytokine release syndrome, flushing, throat irritation, and tremor.
Infusion reaction/data from RAVE Trial
Infusion Reactions
Among the 99 patients treated with Rituxan, 12% experienced at least one infusion related reaction compared with 11% of the 98 patients in the cyclophosphamide group. Infusion-related reactions included cytokine release syndrome, flushing, throat irritation, and tremor. In the Rituxan group, the proportion of patients experiencing an infusion related reaction was 12%, 5%, 4%, and 1% following the first, second, third, and fourth infusions, respectively. Patients were pre-medicated with antihistamine and acetaminophen before each Rituxan infusion and were on background oral corticosteroids which may have mitigated or masked an infusion reaction; however, there is insufficient evidence to determine whether premedication diminishes the frequency or severity of infusion reactions.
Immunogenicity
A total of 23/99 (23%) Rituxan treated patients with GPA and MPA tested positive for HACA by 18 months. The clinical relevance of HACA formation in Rituxan treated patients is unclear.
References
- 1.
- Data on file, Genentech USA/Biogen Idec.
- 2.
- Rituxan [package insert]. South San Francisco, CA: Biogen Idec Inc. and Genentech Inc; July 2012.
- 3.
- Stone JH, Hoffman GS, Merkel PA, et al; for the International Network for the Study of the Systemic Vasculitides (INSSYS). A disease-specific activity index for Granulomatosis with Polyangiitis: modification of the Birmingham Vasculitis Activity Score. International Network for the Study of the Systemic Vasculitides (INSSYS). Arthritis Rheum. 2001;44(4):912-920.
INDICATION
Rituxan (rituximab), in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA).
Rituxan is not recommended for treatment of patients with severe active infections.
IMPORTANT SAFETY INFORMATION
BOXED WARNINGS
Rituxan administration can result in serious, including fatal, adverse reactions. These include:
- infusion reactions
- tumor lysis syndrome (TLS)
- severe mucocutaneous reactions
- progressive multifocal leukoencephalopathy (PML)
Warnings and Precautions
Rituxan administration can also result in additional serious, including fatal, adverse reactions including:
- hepatitis B reactivation
- other infections including bacterial, fungal, new or reactivated viral infections
- cardiovascular events
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 closely for signs of infection if immunosuppressants other than corticosteroids are used concomitantly.
Common adverse reactions include infections, nausea, diarrhea, headache, muscle spasms, anemia and peripheral edema.