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IMURAN is a brand name for Azathioprine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: IMURAN (azathioprine Tablets USP) and IMURAN for injection (azathioprine sodium for Injection, Manufacturer’s Standard) is indicated for: • Renal Homotransplantation IMURAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. • Rheumatoid Arthritis IMURAN is indicated only in adult…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment Renal Homotransplantation The dose of IMURAN (azathioprine) required to prevent rejection and minimize toxicity will vary with individual patients; this necessitates careful management. The initial dose is usually 3-5 mg/kg daily, beginning at the time of transplant.
IMURAN is usually given as a single daily dose on the day of, and in a minority of cases one to three days before, transplantation. IMURAN is often initiated with the intravenous administration of the sodium salt, with subsequent use of tablets (at the same dose level) after the post-operative period.
Intravenous administration of the sodium salt is indicated only in patients unable to tolerate oral medications. Dose reduction to maintenance levels of 1-3 mg/kg daily is usually possible. The dose of IMURAN should not be increased to toxic levels because of threatened rejection.
Discontinuation may be necessary for severe hematologic or other toxicity, even if rejection of the homograft may be a consequence of drug withdrawal. Rheumatoid Arthritis IMURAN is usually given on a daily basis. 0 mg/kg (50-100 mg) given as a single dose or on a twice daily schedule.
The dose may be increased, beginning at six to eight weeks and thereafter by steps at four-week intervals, if there are no serious toxicities and if initial response is unsatisfactory. 5 mg/kg/day. Therapeutic response occurs after several weeks of treatment, usually six to eight; an adequate trial should be a minimum of 12 weeks.
Patients not improved after twelve weeks can be considered refractory. IMURAN may be continued long-term in patients with clinical response, but patients should be monitored carefully, and gradual dosage reduction should be attempted to reduce risk of toxicities.
5 mg/kg or approximately 25 mg daily every four weeks, while other therapy is kept constant. The optimum duration of maintenance IMURAN has not been determined. IMURAN can be discontinued abruptly, but delayed effects are possible. Rest, physiotherapy and salicylates should be continued while IMURAN is given, but it may be possible to reduce the dose of corticosteroids in patients on IMURAN.
Use in Renal Dysfunction Relatively oliguric patients, especially those with tubular necrosis in the immediate post-cadaveric transplant period, may have delayed clearance of IMURAN or its metabolites, or be particularly sensitive to this drug, and are usually given lower doses.
). Fungal, viral, bacterial and protozoal infections may be fatal and should be treated vigorously. Reduction of azathioprine dosage and/or use of other drugs should be considered. Infection with varicella zoster virus (VZV; chickenpox and herpes zoster) may become severe during the administration of immunosuppressants.
Caution should be exercised especially with respect to the following:
Before starting the administration of immunosuppressants, the prescriber should check to see if the patient has a history of VZV. Serologic testing may be useful in determining previous exposure. Patients who have no history of exposure should avoid contact with individuals with chickenpox or herpes zoster.
If the patient is exposed to VZV, special care must be taken to avoid patients developing chickenpox or herpes zoster, and passive immunisation with varicella-zoster immunoglobulin (VZIG) may be considered. If the patient is infected with VZV, appropriate measures should be taken, which may include antiviral therapy and supportive care.
Hypersensitivity Patients with a history of hypersensitivity reaction to 6-mercaptopurine should not be prescribed azathioprine. Imuran® 50mg Tablets / Imuran® 50mg Vial / Azathioprine Page 13 of 37 Macrophage activation syndrome Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop in patients with autoimmune conditions, in particular with inflammatory bowel disease (IBD), and there could potentially be an increased susceptibility for developing the condition with the use of azathioprine.
If MAS occurs, or is suspected, evaluation and treatment should be started as early as possible, and treatment with azathioprine should be discontinued. Physicians should be attentive to symptoms of infection such as EBV and cytomegalovirus (CMV), as these are known triggers for MAS.
1 Pregnant Women 09/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................
2 TABLE OF CONTENTS ............................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................... 4 1 INDICATIONS ...............................................................................................
1 Pediatrics ............................................................................................... 2 Geriatrics ............................................................................................... 4 2 CONTRAINDICATIONS ..................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................. 5 4 DOSAGE AND ADMINISTRATION .................................................................. 2 Recommended Dose and Dosage Adjustment .......................................
3 Reconstitution ....................................................................................... 4 Administration ....................................................................................... 7 5 OVERDOSAGE ..............................................................................................
8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.................. 8 7 WARNINGS AND PRECAUTIONS ................................................................... 1 Special Populations ..............................................................................
1 Pregnant Women ........................................................................... 2 Breast-feeding ............................................................................... 3 Pediatrics .......................................................................................
IMURAN is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Imuran® 50mg Tablets / Imuran® 50mg Vial / Azathioprine Page 5 of 37
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Azathioprine in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Imuran® 50mg Tablets / Imuran® 50mg Vial / Azathioprine Page 7 of 37 Patients with NUDT15 variant Patients with inherited mutated NUDT15 gene are at increased risk for severe 6- mercaptopurine toxicity (See 7 Patients with NUDT15 variant).
These patients generally require dose reduction; particularly those being NUDT15 variant homozygotes (See 7 Patients with NUDT15 variant). Genotypic testing of NUDT15 variants may be considered before initiating 6-mercaptopurine therapy.
In any case, close monitoring of blood counts is necessary. 3 Reconstitution Parenteral Products: Table - Reconstitution Vial Size Volume of Diluent to be Added to Vial Approximate Available Volume Nominal Concentration per mL 50 mg 5 ml 5 ml 10 mg/ml SHAKE UNTIL COMPLETE DISSOLUTION.
No antimicrobial preservative is included. Therefore, reconstitution and dilution must be carried out under full aseptic conditions, preferably immediately before use. Any unused solution should be discarded (see 11 STORAGE, STABILITY AND DISPOSAL).
Intravenous Infusion:
Further dilution into sterile saline is usually made for infusion. The final volume depends on the time for the infusion, usually 30-60 minutes, but as short as five minutes and as long as eight hours for the daily dose. As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discolouration and leakage prior to administration whenever solution and container permit.
Solutions showing haziness, particulate matter, precipitate, discolouration or leakage should not be used. Discard unused portion (see 11 STORAGE, STABILITY AND DISPOSAL). 4 Administration IMURAN® for Injection ONLY: Imuran® 50mg Tablets / Imuran® 50mg Vial / Azathioprine Page 8 of 37 Parenteral Administration FOR INTRAVENOUS USE ONLY.
A 50mg vial should be reconstituted with 5 to 15 mL Sterile Water for Injection, however to obtain a nominal concentration of 10mg/mL, 5mL of Sterile Water for Injection should be used. Once the Sterile Water for Injection has been added, swirl until a clear solution results.
This solution has a pH of approximately 10-12. No antimicrobial preservative is included. Therefore reconstitution and dilution must be carried out under full aseptic conditions, preferably immediately before use. Any unused solution should be discarded.
Further dilution into sterile saline is usually made for infusion; the final volume depends on time for the infusion, usually 30-60 minutes but as short as five minutes and as long as eight hours for the daily dose.
Neuromuscular agents Special care is necessary when azathioprine is given concomitantly with neuromuscular acting agents like tubocurarine or succinylcholine (see
4 Geriatrics ....................................................................................... 15 8 ADVERSE REACTIONS ................................................................................. 1 Adverse Reaction Overview .................................................................
2 Clinical Trial Adverse Reactions ........................................................... 3 Less Common Clinical Trial Adverse Reactions .................................... 5 Post-Market Adverse Reactions...........................................................
18 9 DRUG INTERACTIONS ................................................................................ 4 Drug-Drug Interactions ........................................................................ 5 Drug-Food Interactions ........................................................................
6 Drug-Herb Interactions ........................................................................ 7 Drug-Laboratory Test Interactions ....................................................... 20 10 CLINICAL PHARMACOLOGY........................................................................
1 Mechanism of Action ..................................................................... 2 Pharmacodynamics........................................................................ 3 Pharmacokinetics ..........................................................................
21 11 STORAGE, STABILITY AND DISPOSAL ......................................................... 23 12 SPECIAL HANDLING INSTRUCTIONS ........................................................... 23 PART II: SCIENTIFIC INFORMATION .......................................................................
24 13 PHARMACEUTICAL INFORMATION ............................................................ 24 14 CLINICAL TRIALS ........................................................................................ 1 Clinical Trial by Indication ..............................................................
25 15 MICROBIOLOGY ......................................................................................... 25 16 NON-CLINICAL TOXICOLOGY ...................................................................... 25 PATIENT MEDICATION INFORMATION ..................................................................
30 Imuran® 50mg Tablets / Imuran® 50mg Vial / Azathioprine Page 4 of 37 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS IMURAN (azathioprine Tablets USP) and IMURAN for injection (azathioprine sodium for Injection, Manufacturer’s Standard) is indicated for: • Renal Homotransplantation IMURAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation.
• Rheumatoid Arthritis IMURAN is indicated only in adult patients meeting criteria for classic or definite rheumatoid arthritis as specified by the American Rheumatism Association. IMURAN should be restricted to patients with severe, active and erosive disease not responsive to conventional management including rest, acetylsalicylic acid or other non-steroidal drugs, or with disease-modifying antirheumatic drugs (DMARD’s).
1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (> 65 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.
2 CONTRAINDICATIONS IMURAN is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, […]