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Nausea and vomiting may occur within the first few months of therapy with IMURANand occurred in approximately 12of 676 rheumatoid arthritis patientsThe frequency of gastric disturbance often can be reduced by administration of the drug in divided doses and/or after mealsHoweverin some patientsnausea and vomiting may be severe and may be accompanied by symptoms such as diarrheafevermalaiseand myalgiassee PRECAUTIONSVomiting with abdominal pain may occur rarely with a hypersensitivity pancreatitisHepatotoxicity manifest by elevation of serum alkaline phosphatasebilirubinand/or serum transaminases is known to occur following azathioprine useprimarily in allograft recipientsHepatotoxicity has been uncommonless than 1in rheumatoid arthritis patientsHepatotoxicity following transplantation most often occurs within 6 months of transplantation and is generally reversible after interruption of IMURANA rarebut life-threatening hepatic veno-occlusive disease associated with chronic administration of azathioprine has been described in transplant patients and in one patient receiving IMURAN for panuveitis21,22,23 Periodic measurement of serum transaminasesalkaline phosphataseand bilirubin is indicated for early detection of hepatotoxicityIf hepatic veno-occlusive disease is clinically suspectedIMURAN should be permanently withdrawn.

Imuran therapy should not be initiated in patients who may be pregnantor who are likely to become pregnant without careful assessment of risk versus benefitsee Special Warnings and Precautions for UsePregnancy and Lactation

The maintenance dosage required may range from less than 1 mg/kg bodyweight/day to 3 mg/kg bodyweight/daydepending on the clinical condition being treated and the individual patient responseincluding haematological tolerance.

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org wiki imuran fda center for drug evaluation and research office of communications division of online communications update frequency daily – – january 4, 2016.

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