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Imuran (Azathioprine) - Summary

 

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WARNING

Chronic immunosuppression with this purine antimetabolite increases risk of neoplasia in humans. Physicians using this drug should be very familiar with this risk as well as with the mutagenic potential to both men and women and with possible hematologic toxicities. See WARNINGS.

 

IMURAN SUMMARY

IMURAN® (azathioprine)
50-mg Scored Tablets
mg (as the sodium salt) for I.V. injection,
equivalent to 100 mg azathioprine sterile lyophilized material.

IMURAN (azathioprine), an immunosuppressive antimetabolite, is available in tablet form for oral administration and 100-mg vials for intravenous injection.

IMURAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms.

Renal Homotransplantation: IMURAN 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 or anti-B-cell alloantigen antibody, and other variables. The effect of IMURAN on these variables has not been tested in controlled trials.

Rheumatoid Arthritis: IMURAN is indicated for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms. Aspirin, non-steroidal anti-inflammatory drugs and/or low dose glucocorticoids may be continued during treatment with IMURAN. The combined use of IMURAN with disease modifying anti-rheumatic drugs (DMARDs) has not been studied for either added benefit or unexpected adverse effects. The use of IMURAN with these agents cannot be recommended.

IMURAN NEWS HIGHLIGHTS

Published Studies Related to Imuran (Azathioprine)

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]

Prospective randomized study of azathioprine vs cyclosporine based therapy in primary haplo-identical living-donor kidney transplantation: 20-year experience. [2007.06]

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

A prospective study of anti-chromatin and anti-C1q autoantibodies in patients with proliferative lupus nephritis treated with cyclophosphamide pulses or azathioprine/methylprednisolone. [2007.05]

Randomized study comparing cyclosporine with azathioprine one year after renal transplantation-15-year outcome data. [2007.03.15]

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Clinical Trials Related to Imuran (Azathioprine)

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

Imuran Dosing in Crohn's Disease Study [Terminated]

Myfortic Versus Azathioprine in Systemic Lupus Erythematosus [Recruiting]

TNF Blockade With Remicade in Active Lupus Nephritis WHO Class V (TRIAL ) [Recruiting]

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

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Page last updated: 2007-10-18

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