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IMURAN is indicated for the treatment of active rheumatoid arthritisRAto reduce signs and symptomsAspirinnon-steroidal anti-inflammatory drugs and/or low dose glucocorticoids may be continued during treatment with IMURANThe combined use of IMURAN with disease modifying anti-rheumatic drugsDMARDshas not been studied for either added benefit or unexpected adverse effectsThe use of IMURAN with these agents cannot be recommended.
It is recommended that consideration be given to either genotype or phenotype patients for TPMTPhenotyping and genotyping methods are commercially availableThe most common non-functional alleles associated with reduced levels of TPMT activity are TPMT*2TPMT*3A and TPMT*3CPatients with two nonfunctional alleleshomozygoushave low or absent TPMT activity and those with one non-functional alleleheterozygoushave intermediate activityAccurate phenotypingred blood cell TPMT activityresults are not possible in patients who have received recent blood transfusionsTPMT testing may also be considered in patients with abnormal CBC results that do not respond to dose reductionEarly drug discontinuation in these patients is advisableTPMT TESTING CANNOT SUBSTITUTE FOR COMPLETE BLOOD COUNTCBCMONITORING IN PATIENTS RECEIVING IMURANSee CLINICAL PHARMACOLOGYWARNINGSADVERSE REACTIONS and DOSAGE AND ADMINISTRATION sections.
Imuran tablets are used as an immunosuppressant antimetabolite either alone ormore commonlyin combination with other agentsusually corticosteroidsand procedures which influence the immune responseTherapeutic effect may be evident only after weeks or months and can include a steroid-sparing effectthereby reducing the toxicity associated with high dosage and prolonged usage of corticosteroids.
One of the pathways for inactivation of azathioprine is inhibited by allopurinolPatients receiving IMURAN and allopurinol concomitantly should have a dose reduction of IMURANto approximately 1/3 to 1/4 the usual doseIt is recommended that a further dose reduction or alternative therapies be considered for patients with low or absent TPMT activity receiving IMURAN and allopurinol because both TPMT and XO inactivation pathways are affectedSee CLINICAL PHARMACOLOGYWARNINGSPRECAUTIONSLaboratory Tests and ADVERSE REACTIONS sections.
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