Imuran (Azathioprine) - Summary

IMURAN SUMMARY

IMURAN^® (azathioprine)
50-mg Scored Tablets
mg (as the sodium salt) for I.V. injection,
equivalent to 100 mg azathioprine sterile lyophilized material.

IMURAN (azathioprine), an immunosuppressive antimetabolite, is available in tablet form for oral administration and 100-mg vials for intravenous injection.

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...

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Clinical Trials Related to Imuran (Azathioprine)

Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone [Not yet recruiting]
Description: Pemphigus vulgaris is an autoimmune, chronic and recurrent blistering disease with unknown etiology that affects mucosa and skin of patients with significant morbidity and mortality.

The treatment back-bone is based on prednisolone administration. There are controversies on the opportunity of adding immunosuppressive drugs. For some, they are just corticosteroid sparing drugs. For others, they are disease modifying drugs.

The purpose of this trial is to compare efficacy and safety of azathioprine vs. placebo in new cases of pemphigus vulgaris treated with prednisolone.

Azathioprine & Allopurinol in Inflammatory Bowel Disease Patients [Recruiting]

Rituximab Vasculitis Maintenance Study [Not yet recruiting]
Rituximab is now established as an effective drug for anti-neutrophil cytoplasmic antibody (ANCA) vasculitis following major European and US trials reported in 2010. After a time, its effect wears off and the disease can return. This occurs in at least half of patients within 2 years of receiving Rituximab. A preliminary study in Cambridge has suggested that repeating rituximab every six months stops the disease returning and is safe.

The RITAZAREM trial will find out whether repeating rituximab stops vasculitis returning and whether it works better than the older treatments, azathioprine or methotrexate. It will also tell us how long patients remain well after the repeated rituximab treatments are stopped, and if repeated rituximab is safe. We should also learn useful information about the effects of rituximab on quality of life and economic measures. The trial results will help decide the best treatment for future patients who have their vasculitis initially treated with rituximab.

RITAZAREM aims to recruit patients with established ANCA vasculitis whose disease has come back 'relapsing vasculitis'. All patients will be treated with rituximab and steroids and we anticipate that most will respond well. If their disease is under reasonable control after four months, further treatment with either rituximab (a single dose ever four months for two years) or azathioprine tablets will be chosen randomly. The patients in the rituximab and azathioprine groups will then be compared. Patients will be in the trial for four years.

The study has been designed by members of the European Vasculitis Study group (EUVAS) and the Vasculitis Clinical Research Consortium (VCRC). It will include 190 participants from 30 hospitals in Europe, the USA, Australia and Mexico.

RITAZAREM is being funded by Arthritis Research UK, the U. S. National Institutes of Health and by Roche/Genentech.

Imuran Dosing in Crohn's Disease Study [Terminated]
This study will compare two different dosing methods of azathioprine (IMURAN) in participants with Crohn's disease who are currently taking steroids (e. g. prednisone or budesonide)or who have just started steroids. The study can be up to 54 weeks long. All participants enrolled will receive active drug. Participants will take doses either based upon weight or based on the patient's ability to breakdown the drug (monitored by 6-thioguanine nucleotides (6-TGN) metabolite levels in the blood). All patients enrolled in the study will receive active study drug.

Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis [Recruiting]

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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 >>

PATIENT REVIEWS / RATINGS / COMMENTS

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.

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