Safety Profile
IMPORTANT SAFETY INFORMATION
- Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of Rituxan-based therapy
- Infections have been reported in some patients with prolonged hypogammaglobulinemia (defined as hypogammaglobulinemia >11 months after rituximab exposure)
- New or reactivated viral infections included cytomegalovirus, herpes simplex virus, parvovirus B19, varicella zoster virus, West Nile virus, and hepatitis B and C
- Discontinue Rituxan for serious infections and institute appropriate anti-infective therapy
Rituxan RA pooled placebo-controlled studies1
![Serious infection[1]](/ra/hcp/images/safety/serious-infection.gif)
These data are based on 938 patients treated in phase 2 and phase 3 studies of Rituxan (2 x 1000 mg) or placebo administered with MTX.1
- Infections of any type were experienced by 39% of patients taking Rituxan vs 34% of patients taking placebo1
- The most common infections were nasopharyngitis, upper respiratory tract infections, urinary tract infections, bronchitis, and sinusitis1
Serious Infection data over 8 years1
![Serious infection events per 100 patient-years over 8 years of follow-up[1,2]](/ra/hcp/images/safety/serious-infection-events.gif)
Rate calculations include over 9 years of follow-up.
Data were available for 3194 patients. A total of 3000 patients had >1 year of observations, 2488 patients had >2 years, 1935 patients had >3 years, 1401 patients had >4 years, 627 patients had >5 years, 540 patients had >6 years, 300 patients had >7 years, and 83 patients had ≥8 years. Fatal serious infections included pneumonia, sepsis, and colitis. The rate of serious opportunistic infections in the rituximab all-exposure population was 0.06/100 patient-years compared with 0.09/100 patient-years in the placebo population.1,2
Adapted from van Vollenhoven EULAR 2011.
3194 patients were treated with Rituxan, providing 11962 patient-years of exposure and >9 years of follow up with up to 17 courses. Patients with >5 years of exposure had a 3.28 SIE rate per 100 patient-years.1
Long-term safety from ACR 2009
Dr. Alan Bridges hosts a video presentation on the long-term safety data of Rituxan from ACR 2009.
REFERENCES
- 1.
- Rituxan [package insert]. South San Francisco, CA: Biogen Idec Inc., and Genentech USA, Inc.; February 2012.
- 2.
- van Vollenhoven RF, Emery P, Bingham III CO, et al. Long-term safety profile of rituximab in rheumatoid arthritis clinical trials: pooled analysis of up to 9.5 years follow-up of the retreatment population. Poster presented at: EULAR Congress 2011; May 2011; London, United Kingdom.
