Imuran

Imuran

azathioprine

Manufacturer:

Aspen

Distributor:

Distriphil
Concise Prescribing Info
Contents
Azathioprine
Indications/Uses
In combination w/ corticosteroids &/or other immunosuppressive agents & procedures to enhance the survival of organ transplants (eg, renal, cardiac & hepatic); reduces corticosteroid requirements of renal transplant recipients. Treatment of moderate to severe inflammatory bowel disease (Crohn's disease or ulcerative colitis) in patients in whom corticosteroid therapy is required, who cannot tolerate corticosteroid therapy, or whose disease is refractory to other standard 1st line therapy. As monotherapy or combination therapy for severe RA; SLE; dermatomyositis & polymyositis; autoimmune chronic active hepatitis; pemphigus vulgaris; polyarteritis nodosa; autoimmune hemolytic anemia; chronic refractory ITP; relapsing remittent multiple sclerosis.
Dosage/Direction for Use
Transplantation Adult & childn Up to 5 mg/kg/day on the 1st day of therapy. Maintenance: 1-4 mg/kg/day. Multiple sclerosis Adult 2-3 mg/kg/day. Other conditions Adult & childn Initially 1-3 mg/kg/day. Maintenance: <1-3 mg/kg/day.
Administration
Should be taken on an empty stomach: Take at least 1 hr before or 3 hr after food/milk.
Contraindications
Hypersensitivity to azathioprine & 6-mercaptopurine.
Special Precautions
Increased risk of severe toxicity in patients w/ thiopurine methyltransferase (TPMT)-deficiency & mutated NUDT15 gene. Consider genotypic & phenotypic testing of NUDT15 variants prior to treatment initiation. Do not give live organism vaccines until at least 3 mth after end of treatment. Risk of bone marrow suppression. Perform CBC, including platelets, wkly during the 1st 8 wk of therapy, or more frequently if high dosage is used or in case of severe renal &/or hepatic disorders; repeat mthly thereafter or at least at intervals of ≤3 mth. Routinely monitor LFTs during treatment. Immediately discontinue therapy if jaundice becomes apparent. Not beneficial to patients w/ Lesch-Nyhan syndrome. Risk of developing chromosomal abnormalities; non-Hodgkin's lymphomas & other malignancies; lymphoproliferative disorder. Varicella zoster virus infection may become severe during immunosuppressant administration. Reports of progressive multifocal leukoencephalopathy. Risk of HBV reactivation in hepatitis B carriers or patients w/ previous HBV infection. Consider dose reduction in case of renal or hepatic impairment. Do not give to pregnant women or those likely to become pregnant w/o careful assessment of risk versus benefit. Adequate contraceptive precaution is advised. Do not breastfeed while on treatment.
Adverse Reactions
Viral, fungal & bacterial infections in transplant patients; bone marrow depression, leucopenia. Thrombocytopenia; nausea.
Drug Interactions
Immunosuppressive activity could result in atypical & potentially deleterious response to live vaccines. Severe myelosuppression w/ ribavirin (inosine monophosphate dehydrogenase inhibitor). Reports of haematological abnormalities w/ cytostatic drugs or drugs which may have myelosuppressive effects (eg, penicillamine, trimethoprim/sulfamethoxazole, ACE inhibitors, cimetidine, indomethacin). Decreased metabolism w/ allopurinol, oxipurinol, thiopurinol & other xanthine oxidase inhibitors. Aminosalicylate derivatives (eg, olsalazine, mesalazine or sulphasalazine) inhibit the TPMT enzyme. Increased 6-mercaptopurine AUC w/ MTX. Transient increases in 6-thioguanine nucleotide (an active metabolite of azathioprine) levels & decrease in mean leukocyte count in the initial wk following infliximab infusion. Antagonised effect of non-depolarising muscle relaxants eg, curare, d-tubocurarine, pancuronium. Potentiated neuromuscular blockade effect of succinylcholine. Reports of inhibited anticoagulant effect of warfarin & acenocoumarol.
MIMS Class
Immunosuppressants
ATC Classification
L04AX01 - azathioprine ; Belongs to the class of other immunosuppressants.
Presentation/Packing
Form
Imuran tab 50 mg
Packing/Price
100's