About Rituxan
Rituxan gives patients more time with less RA by providing:
- Rituxan provides an ACR response that lasts through 6 months in patients who have persistent, active disease despite prior anti-TNF therapy1
- Rituxan protects joints by slowing the progression of structural damage
- Patients should be evaluated for their next course of Rituxan at the first signs of the return of disease activity, typically around 6 months after their previous course2
- Rituxan has an established safety profile5
- Rituxan selectively targets only CD20+ B cells2—not the entire immune system.
- Rituxan has more than 10 years of clinical experience across all indications and more than 1 million patient-exposures5
- A network of support and access services
In this section:
ACR Efficacy:
Learn more about how Rituxan delivers efficacy that lasts through 6 months with one course of therapy.
Subsequent Courses of Treatment:
Access research results examining the safety and efficacy of subsequent courses of Rituxan treatments.
MOA:
Learn about how Rituxan selectively targets CD20+ B cells — not the entire immune system — to treat RA.
Clinical Experience:
Find out about Rituxan's clinical history, which includes more than 10 years of clinical experience and more than 1,000,000 exposures across approved indications.7
FAQs:
Access a list of frequently asked questions about Rituxan.
Important Safety Information
Indication
Rituxan (Rituximab) in combination with methotrexate is indicated to reduce signs and symptoms and slows the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.
In RA clinical trials, the most common adverse events with greater incidence in the group receiving RITUXAN (n=540) vs the placebo group (n=398) were hypertension (8% vs 5%), nausea (8% vs 5%), upper respiratory tract infection (7% vs 6%), arthralgia (6% vs 4%), pyrexia (5% vs 2%), and pruritus (5% vs 1%).
Boxed WARNINGS
Fatal Infusion Reactions: Rituxan administration can result in serious, including fatal infusion reactions. Deaths within 24 hours of RITUXAN infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion.
Tumor Lysis Syndrome (TLS): Acute renal failure requiring dialysis with instances of fatal outcome can occur in the setting of TLS following treatment of non-Hodgkin’s lymphoma (NHL) patients with RITUXAN.
Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions, can occur in patients receiving RITUXAN.
Progressive Multifocal Leukoencephalopathy (PML): JC virus infection resulting in PML and death can occur in patients treated with Rituxan.
Please see full prescribing information, including Boxed WARNINGS.
REFERENCES
| 1. | Cohen SB, Emery P, Greenwald MW, et al; for the REFLEX Trial Group. Rituximab for rheumatoid arthritis refractory to anti–tumor necrosis factor therapy: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum. 2006;54(9):2793-2806. doi:10.1002/art.22025. |
| 2. | Keystone E, Emery P, Peterfy CG, et al. Prevention of joint structural damage at 1 year with rituximab in rheumatoid arthritis patients with an inadequate response to one or more TNF inhibitors (REFLEX study) [abstract OP0016]. Ann Rheum Dis. 2006;65(suppl II):58. http://www.abstracts2view.com/eular. Accessed January 3, 2008. |
| 5. | Data on file, Genentech/Biogen Idec. |
| 7. | Kremer JM, Tony H, Tak PP, et al. Efficacy of rituximab in active RA patients with an inadequate response to one or more TNF inhibitors. Poster presented at: The European League Against Rheumatism Annual European Congress of Rheumatology; June 21-24, 2006; Amsterdam, The Netherlands. |