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TPMT TESTING CANNOT SUBSTITUTE FOR COMPLETE BLOOD COUNTCBCMONITORING IN PATIENTS RECEIVING IMURANTPMT genotyping or phenotyping can be used to identify patients with absent or reduced TPMT activityPatients with low or absent TPMT activity are at an increased risk of developing severelife-threatening myelotoxicity from IMURAN if conventional doses are givenPhysicians may consider alternative therapies for patients who have low or absent TPMT activityhomozygous for non-functional allelesIMURAN should be administered with caution to patients having one non-functional alleleheterozygouswho are at risk for reduced TPMT activity that may lead to toxicity if conventional doses are givenDosage reduction is recommended in patients with reduced TPMT activityEarly drug discontinuation may be considered in patients with abnormal CBC results that do not respond to dose reduction.

Patients with inherited mutated NUDT15 gene are at increased risk for severe azathioprine toxicitysee 4.4These patients generally require dose reductionparticularly those being NUDT15 variant homozygotessee 4.4Genotypic testing of NUDT15 variants may be considered before initiating azathioprine therapyIn any caseclose monitoring of blood counts is necessary.

Cases of JC virus-associated infection resulting in progressive multifocal leukoencephalopathyPMLsometimes fatalhave been reported in patients treated with immunosuppressantsincluding ImuranRisk factors for PML include treatment with immunosuppressant therapies and impairment of immune functionConsider the diagnosis of PML in any patient presenting with new-onset neurological manifestations and consider consultation with a neurologist as clinically indicatedConsider reducing the amount of immunosuppression in patients who develop PMLIn transplant patientsconsider the risk that the reduced immunosuppression represents to the graft.

IMURAN has been reported to cause temporary depression in spermatogenesis and reduction in sperm viability and sperm count in mice at doses 10 times the human therapeutic dose10 a reduced percentage of fertile matings occurred when animals received 5 mg/kg11.

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the use of imuran in nursing mothers is not recommended.