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Azasan (Azathioprine) - Summary

 

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AZASAN SUMMARY

AZASAN®, an immunosuppressive antimetabolite, is available in tablet form for oral administration.

AZASAN® is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of severe, active rheumatoid arthritis unresponsive to rest, aspirin, or other nonsteroidal anti-inflammatory drugs, or to agents in the class of which gold is an example.

Renal Homotransplantation: AZASAN® is indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a 5-year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti-donor and anti B-cell alloantigen antibody, and other variables. The effect of azathioprine on these variables has not been tested in controlled trials.

Rheumatoid Arthritis: AZASAN® is indicated only in adult patients meeting criteria for classic or definite rheumatoid arthritis as specified by the American Rheumatism Association. AZASAN® should be restricted to patients with severe, active and erosive disease not responsive to conventional management including rest, aspirin, or other nonsteroidal drugs or to agents in the class of which gold is an example. Rest, physiotherapy, and salicylates should be continued while AZASAN® is given, but it may be possible to reduce the dose of corticosteroids in patients on AZASAN®. The combined use of AZASAN® with gold, antimalarials, or penicillamine has not been studied for either added benefit or unexpected adverse effects. The use of AZASAN® with these agents cannot be recommended.

AZASAN NEWS HIGHLIGHTS

Published Studies Related to Azasan (Azathioprine)

A Multicenter, Randomized, Double-Blind Trial of Everolimus Versus Azathioprine and Placebo to Maintain Steroid-Induced Remission in Patients With Moderate-to-Severe Active Crohn's Disease. [2008.07.30]

Health-related quality of life and treatment burden in patients with proliferative lupus nephritis treated with cyclophosphamide or azathioprine/ methylprednisolone in a randomized controlled trial. [2007.08]

Health-Related Quality of Life and Treatment Burden in Patients with Proliferative Lupus Nephritis Treated with Cyclophosphamide or Azathioprine/Methylprednisolone in a Randomized Controlled Trial. [2007.07.15]

6-thioguanine nucleotide-adapted azathioprine therapy does not lead to higher remission rates than standard therapy in chronic active crohn disease: results from a randomized, controlled, open trial. [2007.07]

Mycophenolate Mofetil versus Azathioprine for Prevention of Chronic Allograft Dysfunction in Renal Transplantation: The MYSS Follow-Up Randomized, Controlled Clinical Trial. [2007.06]

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Clinical Trials Related to Azasan (Azathioprine)

Imuran (Azathioprine) Dose-Ranging Study in Crohn's Disease [Recruiting]

Phase II Open-Label, Multi-Center, Prospective, Randomized Study of LCP-Tacro vs. Azathioprine for the Treatment of Autoimmune Hepatitis [Enrolling by invitation]

Imuran Dosing in Crohn's Disease Study [Terminated]

WEGENT - Comparison of Methotrexate or Azathioprine as Maintenance Therapy for ANCA-Associated Vasculitides [Active, not recruiting]

Efficacy & Safety of Infliximab Monotherapy Vs Combination Therapy Vs AZA Monotherapy in Ulcerative Colitis (Part 1) Maintenance Vs Intermittent Therapy for Maintaining Remission (Part 2)(Study P04807AM2) [Recruiting]

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Page last updated: 2008-08-10

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