The RITUXAN for RA EXPERIENCE Program

 

through Genentech
Rheumatology
Access Solutions

$4,000 per
12-month period
toward the cost of
Rituxan for eligible patients

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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 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

RITUXAN administration can result in serious, including fatal, adverse reactions. These include: infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, and 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

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.

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The rate of serious infections with Rituxan remains consistent over time and through multiple courses

Rate of serious infection events  

Data were available for 3189 patients. A total of 2928 patients had >1 year of observations, 2472 patients had >2 years, 1540 patients had >3 years, 685 patients had >4 years, 587 patients had >5 years and 310 patients had >6 years

In the pivotal placebo-controlled trials

  • Serious infections occurred in 2% of patients taking Rituxan vs 1% of patients taking placebo1
  • Infections of any type were experienced by 39% of patients taking Rituxan vs 34% of patients taking placebo1

SAFETY INFORMATION: Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and up to one year of Rituxan-based therapy
 

The rate of serious infections was 4.25 per 100 patient-years in Rituxan clinical trials and open label extension studies

Incidence of serious infections  
  • The rate of serious infections seen in Rituxan clinical trials is within the range seen in other DMARD therapies

Rituxan has an established safety profile2:

  • More than 7 years of clinical trial experience in RA
  • A limited number of patients receiving up to 13 courses in ongoing trials
  • Approximately 110,000 RA patients have been exposed to Rituxan worldwide
References
1.
Rituxan [package insert]. South San Francisco, CA: Biogen Idec Inc. and Genentech USA, Inc.; February 2010.
2.
Data on file, Genentech USA/Biogen Idec.
6.
Finckh A, Ciurea A, Brulhart L, et al; on the behalf of the doctors of the Swiss Clinical Quality Management Programme for Rheumatoid Arthritis. Which subgroup of patients with rheumatoid arthritis benefits from switching to rituximab versus alternative anti-tumour necrosis factor (TNF) agents after previous failure of an anti-TNF agent? Ann Rheum Dis. 2010;69(2):387-393. Doi:10.1136/ard.2008.105064.
7.
van Vollenhoven RF, Emery P, Bingham CO, et al. Long-term safety of rituximab: follow-up of the RA clinical trials and retreatment population. Presented at European League Against Rheumatism Conference; June 16-19, 2010; Rome, Italy.
8.
van Vollenhoven RF, Emery P, Bingham CO III, et al. Long-term safety of rituximab: Follow-up of the rheumatoid arthritis (RA) clinical trials and re-treatment population. Presented at: The American College of Rheumatology Annual Scientific Meeting; October 16-21, 2009; Philadelphia, PA.
9.
Dixon WG, Watson K, Lunt M, British Society for Rheumatology Biologics Register Control Centre Consortium, Silman AJ, Symmons DPM; on behalf of the British Society for Rheumatology Biologics Register. Rates of serious infection, including site-specific and bacterial intracellular infection, in rheumatoid arthritis patients receiving anti–tumor necrosis factor therapy: Results from the British Society for Rheumatology Biologics Register. Arthritis Rheum. 2006;54(8):2368-2376. doi:10.1002/ art.21978.
10.
Listing J, Strangfeld A, Kary S, et al. Infections in patients with rheumatoid arthritis treated with biologic agents. Arthritis Rheum. 2005;52(11):3403-3412. doi:10.1002/art.21386.