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Information about Imuran.
If you have an allergy to azathioprine or any other part of Imuranazathioprine tabletsIf you are allergic to any drugs like this oneany other drugsfoodsor other substancesTell your doctor about the allergy and what signs you hadlike rashhivesitchingshortness of breathwheezingcoughswelling of facelipstongueor throator any other signsIf you have ever been treated with chlorambucilcyclosporineor melphalan in the pastIf you are breast-feeding or plan to breast-feed.
The principal and potentially serious toxic effects of IMURAN are hematologic and gastrointestinalThe risks of secondary infection and malignancy are also significantsee WARNINGSThe frequency and severity of adverse reactions depend on the dose and duration of IMURAN as well as on the patient’s underlying disease or concomitant therapiesThe incidence of hematologic toxicities and neoplasia encountered in groups of renal homograft recipients is significantly higher than that in studies employing IMURAN for rheumatoid arthritisThe relative incidences in clinical studies are summarized below:
The dose of IMURAN required to prevent rejection and minimize toxicity will vary with individual patientsthis necessitates careful managementThe initial dose is usually 3 to 5 mg/kg dailybeginning at the time of transplantIMURAN is usually given as a single daily dose on the day ofand in a minority of cases 1 to 3 days beforetransplantationDose reduction to maintenance levels of 1 to 3 mg/kg daily is usually possibleThe dose of IMURAN should not be increased to toxic levels because of threatened rejectionDiscontinuation may be necessary for severe hematologic or other toxicityeven if rejection of the homograft may be a consequence of drug withdrawal.
Severe leukopeniathrombocytopeniaanemias including macrocytic anemiaand/or pancytopenia may occur in patients being treated with IMURANSevere bone marrow suppression may also occurPatients with intermediate thiopurine S-methyl transferaseTPMTactivity may be at an increased risk of myelotoxicity if receiving conventional doses of IMURANPatients with low or absent TPMT activity are at an increased risk of developing severelife-threatening myelotoxicity if receiving conventional doses of IMURANTPMT genotyping or phenotyping can help identify patients who are at an increased risk for developing IMURAN toxicity2-9See PRECAUTIONSLaboratory TestsHematologic toxicities are dose-related and may be more severe in renal transplant patients whose homograft is undergoing rejectionIt is suggested that patients on IMURAN have complete blood countsincluding platelet countsweekly during the first monthtwice monthly for the second and third months of treatmentthen monthly or more frequently if dosage alterations or other therapy changes are necessaryDelayed hematologic suppression may occurPrompt reduction in dosage or temporary withdrawal of the drug may be necessary if there is a rapid fall in or persistently low leukocyte countor other evidence of bone marrow depressionLeukopenia does not correlate with therapeutic effecttherefore the dose should not be increased intentionally to lower the white blood cell count.
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the oral ld 50 s for single doses of imuran in mice and rats are 2500 mg kg and 400 mg kg, respectively.