WARNING
Chronic immunosuppression with this purine antimetabolite increases risk of neoplasia in humans. 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. See WARNINGS.
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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)
Azathioprine or 6-mercaptopurine for induction of remission in Crohn's disease. [2009.10.07]
CONCLUSIONS: Azathioprine and 6-mercaptopurine are effective therapy for inducing remission in active Crohn's disease. The OR of response increases after > 17 weeks of therapy, suggesting that there is a minimum length of time for a trial of azathioprine or 6-mercaptopurine therapy. Adverse events were more common among patients on active therapy.
Randomized study of interferon beta-1a, low-dose azathioprine, and low-dose corticosteroids in multiple sclerosis. [2009.08]
BACKGROUND: Studies evaluating interferon beta (IFNbeta) for multiple sclerosis (MS) showed only partial efficacy. In many patients, IFNbeta does not halt relapses or disability progression. One strategy to potentially enhance efficacy is to combine IFNbeta with classical immunosuppressive agents, such as azathioprine (AZA) or corticosteroids, commonly used for other autoimmune disorders. OBJECTIVE: The Avonex-Steroids-Azathioprine study was placebo-controlled trial and evaluated efficacy of IFNbeta-1a alone and combined with low-dose AZA alone or low-dose AZA and low-dose corticosteroids as initial therapy... CONCLUSION: In IFNbeta-naive patients with early active RRMS, combination treatment did not show superiority over IFNbeta-1a monotherapy.
Safe conversion of mycophenolate mofetil to azathioprine in kidney transplant recipients with sirolimus-based immunosuppression. [2009.04]
AIM: Mycophenolate mofetil (MMF) is a powerful immunosuppressive drug with established efficacy and safety. The long-term use of MMF may bring increased risk of for infection and malignancy and also increased cost of transplantation. The search for minimization of immunosuppressive protocol has led to an open randomized clinical trial of conversion from MMF to azathioprine (AZA)... CONCLUSION: In general, replacing MMF with AZA in stable renal transplant recipients is well tolerated and was cost effective with no increased risk of rejection. As the this study was on relatively small samples, larger and longer follow-up studies will be needed to confirm these expected advantages for the long-term outcome and to assess the long-term safety of this minimization of immunosuppressive therapy.
Azathioprine is superior to budesonide in achieving and maintaining mucosal healing and histologic remission in steroid-dependent Crohn's disease. [2009.03]
BACKGROUND: The effects of azathioprine (AZA) and budesonide (BUD) on mucosal healing and histologic remission of Crohn's disease (CD) are insufficiently studied. In this prospective study we evaluated the comparative effects of AZA and BUD on endoscopic and histologic activity in patients with steroid-dependent Crohn's ileocolitis or proximal colitis who had achieved clinical remission on conventional steroids... CONCLUSIONS: In patients with steroid-dependent inflammatory Crohn's ileocolitis or proximal colitis who achieve clinical remission with conventional steroids, a 1-year treatment with AZA was superior to BUD in achieving and maintaining mucosal healing and histologic remission.
Azathioprine withdrawal in patients with Crohn's disease maintained on prolonged remission: a high risk of relapse. [2009.01]
BACKGROUND & AIMS: Azathioprine (AZA) withdrawal in Crohn's disease after long-term remission under treatment is controversial. In a Groupe d'Etude Therapeutique des Affections Inflammatoires du tube Digestif randomized, double-blind, placebo-controlled trial, the hypothesis that AZA withdrawal was not inferior to AZA continuation in patients in prolonged clinical remission could not be shown... CONCLUSIONS: Our results confirm that AZA withdrawal is associated with a high risk of relapse, whatever the duration of remission under this treatment. These data suggest that if AZA is well tolerated, it should not be interrupted.
Clinical Trials Related to Imuran (Azathioprine)
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.
Imuran (Azathioprine) Dose-Ranging Study in Crohn's Disease [Recruiting]
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.
WEGENT - Comparison of Methotrexate or Azathioprine as Maintenance Therapy for ANCA-Associated Vasculitides [Active, not recruiting]
Remission of ANCA-associated vasculitis can be obtained in approximately 80% of the patients
with a combination of corticosteroids and cyclophosphamide. However, relapses are frequent.
This point warrants the prescription of a maintenance treatment with a less toxic
immunosuppressant for several months to years. The optimal drug in this indication is not
determine. We decided therefore to compare the 2 most used drugs in this indication.
Induction therapy consists in the combination of corticosteroids and intravenous
cyclophosphamide pulses. Corticotherapy consisted first in one daily methylprednisolone
pulse, for 1 to 3 days, followed by oral prednisolone at the dose of 1 mg/kg/d for 3 weeks,
then progressively tapered and stopped at the 18th month from the diagnosis. Cyclophosphamide
is administered every 2 weeks for the first 3 bolus (0. 6 g/m2 - D1, 15 and 30), then every 3
weeks (0. 7 g/m2). Once remission is achieved, patients receive 3 additional bolus (0. 7 g/m2).
At that time, patients are randomized for a maintenance treatment with azathioprine (2
mg/kg/d, orally) or oral methotrexate (starting at the dose of 0. 3 mg/kg/wk, then
progressively increased every weeks by 2. 5mg, if necessary, to a maximum and optimal dose of
25 mg/wk) for 12 months.
Azathioprine Versus Corticosteroids in Parthenium Dermatitis [Completed]
The dermatitis caused by the substances which come in contact with the skin is known as
contact dermatitis. When such a reaction is caused by the agents suspended in the air, it is
called air-borne contact dermatitis (ABCD). Parthenium hysterophorus at present is the
commonest cause of ABCD in India though in some cases other plants have also been found to
cause ABCD. Parthenium dermatitis is one of the major health problems in dermatology in our
country. Though it has very little mortality, the disease normally continues to persist with
variable remissions and relapses causing great distress and morbidity. Corticosteroids,
topical and systemic have been the mainstay of the treatment so far. Therefore, the patients
with ABCD who have to take corticosteroids for long periods of time tend to develop severe
and sometimes irreversible side effects of the therapy. Azathioprine is an immunosuppressive
drug which acts by inhibiting the T lymphocytes. In our previous studies we have been able
to induce remissions in these patients with azathioprine used as daily as well as monthly
bolus dose, without having to use systemic corticosteroids. The side effect with
azathioprine in these studies were almost absent.
We have therefore planned to study the therapeutic efficacy of azathioprine weekly pulse
doses versus daily azathioprine in achieving remissions in patients having Parthenium
dermatitis and to monitor the side effects of both the regimens.
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.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Imuran has an overall score of 7. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
| | 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: 2009-10-20
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