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WARNING - MALIGNANCY
Chronic immunosuppression with IMURAN, a purine antimetabolite increases risk of malignancy in humans. Reports of malignancy include post-transplant lymphoma and hepatosplenic T-cell lymphoma (HSTCL) in patients with inflammatory bowel disease. Physicians using this drug should be very familiar with this risk as well as with the mutagenic potential to both men and women and with possible hematologic toxicities. Physicians should inform patients of the risk of malignancy with IMURAN. See WARNINGS.
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IMURAN SUMMARY
IMURAN (azathioprine), an immunosuppressive antimetabolite, is available in tablet form for oral administration.
IMURAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms.
Renal Homotransplantation: IMURAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a 5-year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti-donor or anti-B-cell alloantigen antibody, and other variables. The effect of IMURAN on these variables has not been tested in controlled trials.
Rheumatoid Arthritis: IMURAN is indicated for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms. Aspirin, non-steroidal anti-inflammatory drugs and/or low dose glucocorticoids may be continued during treatment with IMURAN. The combined use of IMURAN with disease modifying anti-rheumatic drugs (DMARDs) has not been studied for either added benefit or unexpected adverse effects. The use of IMURAN with these agents cannot be recommended.
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NEWS HIGHLIGHTS
Published Studies Related to Imuran (Azathioprine)
Interferon, azathioprine and corticosteroids in multiple sclerosis: 6-year
follow-up of the ASA cohort. [2012]
combined with low-dose azathioprine and prednisone in multiple sclerosis... CONCLUSION: The tested combined therapeutic regimen does not improve long-term
A randomized trial of methotrexate versus azathioprine for severe atopic eczema. [2011.08]
BACKGROUND: Patients with severe atopic eczema frequently require systemic treatment to control their disease. Methotrexate and azathioprine are proposed as off-label treatment options, but direct comparisons are lacking. OBJECTIVES: We sought to compare the efficacy and safety of methotrexate versus azathioprine in adults with severe atopic eczema... CONCLUSION: Both treatments achieved clinically relevant improvement and were safe in the short term. Methotrexate and azathioprine are appropriate options for the treatment of severe atopic eczema. Copyright (c) 2011 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.
A pragmatic randomized controlled trial of thiopurine methyltransferase genotyping prior to azathioprine treatment: the TARGET study. [2011.06]
AIM: To conduct a pragmatic, randomized controlled trial to assess whether thiopurine methyltransferase (TPMT) genotyping prior to azathioprine reduces adverse drug reactions (ADRs)... CONCLUSION: Our work supports the strong evidence that individuals with TPMT variant homozygosity are at high risk of severe neutropenia, whereas TPMT heterozygotes are not at increased risk of ADRs at standard doses of azathioprine.
Steroids and azathioprine in the treatment of IgA nephropathy. [2011.06]
AIM: IgA nephropathy (IgAN) is a very common glomerulonephritis among young adults, but the best therapeutic approach has not been fully elucidated. This study evaluated the effect of two different treatment regimes in IgAN, steroids alone or in combination with azathioprine... CONCLUSIONS: Both, steroid treatment alone and steroids in combination with azathioprine seem to be effective in reducing the severity of proteinuria and stabilizing renal function in IgAN. Patients who do not respond to steroids may have a better response with the combination of steroids and azathioprine.
Cyclosporine versus azathioprine therapy in high-risk idiopathic membranous nephropathy patients: A 3-year prospective study. [2011.03]
There is no consensus regarding the modality of therapy for idiopathic membranous nephropathy (IMN), especially for patients who did not react to treatment with cytotoxic drugs. This study followed prospectively for 3-year IMN patients who did not react to Ponticelli protocol comparing effects of 2-year course of cyclosporine (CsA) with azathioprine (Aza) treatment both with small doses of prednisolone...
Clinical Trials Related to Imuran (Azathioprine)
Imuran (Azathioprine) Dose-Ranging Study in Crohn's Disease [Terminated]
The purpose of this study is to identify an optimal weight based dose of azathioprine that
is safe and effective in the treatment of subjects with active Crohn's disease requiring
treatment with corticosteroids, and for maintaining remission in those subjects.
Drug Use Investigation for IMURAN (Azathioprine) Tablet (Hepatic Transplantation) [Completed]
This post-marketing surveillance (PMS) study is designed to investigate the efficacy and
safety of azathioprine tablets in Japanese subjects whom liver transplantation is performed.
Special Drug Use Investigation for IMURAN (Azathioprine) Tablet (Pulmones Transplantation) [Completed]
This post-marketing surveillance study is to investigate the efficacy and safety of
azathioprine tablets in subjects whom lung transplantation is performed.
LCP-Tacro vs. Azathioprine for the Treatment of Autoimmune Hepatitis [Completed]
An open-label, multi-center, prospective, randomized study to evaluate the efficacy, safety
and tolerability of LCP-Tacro tablets given once daily vs. azathioprine, each in combination
with prednisone, for the treatment of autoimmune hepatitis (AIH).
Correlation of Genetic Polymorphism of Azathioprine Metabolizing Enzymes and Correlation to Clinical Adverse Effects [Completed]
Azathioprine (AZA) has long been used in dermatology in treating autoimmune bullous
dermatoses and generalized eczematous disorders as well as some photodermatoses. Its
metabolic process inside human body and its side effects relies on genetic polymorphism of
some enzymes such as thiopurine s-methyltransferase (TPMT) and inosine triphosphate
pyrophosphatase gene (ITPA). This study aims to analyze the relative contribution of TMPT
and ITPA mutations to the development of toxicity induced by AZA treatment and to detect the
correlation of the genetic polymorphism.
Reports of Suspected Imuran (Azathioprine) Side Effects
Anaemia (16),
Pneumonia (14),
Liver Disorder (13),
Diarrhoea (12),
Pyrexia (11),
Drug Interaction (10),
Pleural Effusion (10),
Pancytopenia (10),
Drug Ineffective (9),
Herpes Zoster (9), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Imuran has an overall score of 8.50. The effectiveness score is 9 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
| | Imuran review by 37 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | CROHN'S DISEASE |
| Dosage & duration: | | 3 PILLS A DAY taken everyday for the period of 10 YEARS |
| Other conditions: | | NONE |
| Other drugs taken: | | NONE | | |
Reported Results |
| Benefits: | | I could completelly leave the corticosteroids and didn't feel the pain and inflamation except for some special periods of stress. Consequently I got a better quality of life. |
| Side effects: | | I have not detected any side effects but the analysis I take every six months show that the amount of white blood except for a very low decrease of white cells and anemia. |
| Comments: | | I take one pill on breakfast, one on lunch and another one on dinner. |
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| | Imuran review by 30 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Lupus |
| Dosage & duration: | | 50mg taken once daily for the period of 1.5 years |
| Other conditions: | | asthma |
| Other drugs taken: | | Nuvaring, Prozac, Xanax, Plaquenil, Vicoprofin | | |
Reported Results |
| Benefits: | | The treatment reduced the symptoms of SLE that I was suffering from: these were pain and inflammation in my wrists, hands and fingers. It also reduced some puffiness in my face - perhaps b/c I had inflammation in my jaw joint. |
| Side effects: | | I did not notice changes in my hair or skin, but I believe that this drug might increase my fatigue somewhat. I believe this b/c when I went to a higher dose (25 to 50 mg) I needed more rest.
I have gained some weight, but am unsure if this is a side-effect of Imuran or of lifestyle changes due to less physical activity. (I suspect it is the latter) |
| Comments: | | 1 year at 25 mg
.5 year at 50 mg
once a day in both cases |
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Page last updated: 2013-02-10
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