Safety Profile

Important Safety Information
Infusion Reactions

IMPORTANT SAFETY INFORMATION

  • Rituxan can cause severe, including fatal, infusion reactions
  • Severe reactions typically occurred during the first infusion with time to onset of 30 to 120 minutes
  • Institute medical management (e.g. glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion reactions as needed

Rituxan RA pooled placebo-controlled studies1

Acute infusion reactions from first infusion to second infusion[1] View Full Size

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

Infusion-related reaction data through 7 courses of Rituxan1

Infusion-related reactions were the most common adverse event. Most reactions were mild to moderate in severity, and occurred after Course 1 (23%); less than 1% were serious.

Proportion of patients with infusion-related reactions through 7 courses of Rituxan[1] View Full Size

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. Date of treatment initiation differed among studies included in this pooled analysis. To date a limited number of patients have received >9 years of treatment and up to 17 courses of treatment. Patients received Rituxan or placebo in the original study, followed by Rituxan as rescue therapy or as part of an open-label extension study1

Data adapted from van Vollenhoven EULAR 2011.

Care should be exercised in interpreting open-label results, due to the inability to minimize bias.

 

Long-term safety from ACR 2009

Dr. Alan Bridges hosts a video presentation on the long-term safety data of Rituxan, from ACR 2009.

 

Click here to view other Rituxan videos

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.
Infections
Post-Rituxan Safety

May we also suggest

INDICATION

Rituxan (rituximab) in combination with methotrexate is indicated for the treatment of adult patients with moderately- to severely- active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.

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:

WARNINGS AND PRECAUTIONS

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

Patients should be closely observed for signs of infection if biologic agents and /or DMARDs other than methotrexate are used concomitantly.

Common adverse reactions include infusion reactions and infections.

For additional safety information, please see the full prescribing information, including BOXED WARNINGS and Medication Guide.

Attention Healthcare Provider: Provide Medication Guide to patient prior to Rituxan infusion.

Indication & Safety INFORMATION

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