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Azathioprine: Brands, Price & Uses in Bangladesh
Azathioprine is an immunosuppressive antimetabolite with the following evidence-based uses: Established / FDA-approved indications Prevention of kidney (renal) transplant rejection - used and more.
About Azathioprine
Indications of Azathioprine
Azathioprine is an immunosuppressive antimetabolite with the following evidence-based uses:
Established / FDA-approved indications
- Prevention of kidney (renal) transplant rejection - used, usually in combination with corticosteroids and/or other immunosuppressants, to reduce the risk of the immune system rejecting a transplanted kidney.
- Rheumatoid arthritis (moderate to severe, active) - used in adults who have not responded adequately to conventional first-line disease-modifying antirheumatic drugs (DMARDs).
Guideline-supported / off-label uses
- Inflammatory bowel disease (Crohn's disease and ulcerative colitis) - used as a steroid-sparing maintenance agent, generally as part of combination management.
- Autoimmune hepatitis - used, typically combined with corticosteroids, to maintain remission.
- Systemic lupus erythematosus (SLE) and other autoimmune conditions such as autoimmune hemolytic anemia and myasthenia gravis - used off-label under specialist supervision when other therapies are inadequate.
Use of Azathioprine for any indication should be directed and monitored by a physician experienced in immunosuppressive therapy.
Dosage & Administration of Azathioprine
Dosing of Azathioprine is individualized per indication, body weight, and clinical/laboratory response, and must be supervised by a physician experienced in immunosuppressive therapy.
| Indication | Adult Dose |
|---|---|
| Kidney transplant rejection prophylaxis | Initial dose up to 3-5 mg/kg/day, usually started at or shortly before transplantation; maintenance dose typically 1-3 mg/kg/day, adjusted to the lowest effective dose based on clinical response and blood counts. |
| Rheumatoid arthritis | Initial dose approximately 1 mg/kg/day (about 50-100 mg) given as a single dose or in two divided doses. If response is insufficient after 6-8 weeks, the dose may be increased by 0.5 mg/kg/day at 4-week intervals, up to a maximum of about 2.5 mg/kg/day. A therapeutic trial of at least 12 weeks is generally required before concluding a lack of benefit. |
| Inflammatory bowel disease / autoimmune hepatitis (guideline-supported use) | Typically 1-2.5 mg/kg/day, individualized, often combined with corticosteroids as a steroid-sparing maintenance strategy. |
Renal impairment
Lower doses are recommended in patients with reduced kidney function (including oliguric transplant recipients), as drug clearance may be delayed; dose should be adjusted based on close monitoring of blood counts and clinical response.
Hepatic impairment
Use with caution and closer monitoring, as Azathioprine and its metabolites are hepatically processed; dose reduction may be required in significant hepatic impairment.
Baseline and periodic monitoring of complete blood count (CBC) and liver function tests is required throughout treatment (see Precautions and Warnings).
Side Effects of Azathioprine
Side effects of Azathioprine are generally dose-related and reversible with dose reduction or discontinuation, but some are serious.
Common
- Nausea, vomiting, loss of appetite, abdominal discomfort
- Leukopenia (low white blood cell count)
- Increased susceptibility to infections
Less common but significant
- Thrombocytopenia and anemia
- Hepatotoxicity (elevated liver enzymes, cholestasis)
- Pancreatitis
- Hair thinning
Serious/rare
- Severe bone marrow suppression (agranulocytosis, pancytopenia), particularly in patients with reduced TPMT/NUDT15 enzyme activity
- Increased long-term risk of malignancy, including lymphoma and non-melanoma skin cancers (see boxed warning)
- Hypersensitivity reactions (fever, rash, myalgia, hypotension, malaise) - typically require immediate discontinuation
- Serious opportunistic infections due to immunosuppression
Patients should seek urgent medical attention for fever, unusual bruising/bleeding, signs of infection, jaundice, or severe abdominal pain while taking Azathioprine.
Contraindications of Azathioprine
Azathioprine is absolutely contraindicated in:
- Patients with known hypersensitivity to Azathioprine or to mercaptopurine (due to cross-reactivity), or to any excipient of the formulation.
- Pregnant patients being treated for rheumatoid arthritis (per approved labeling for this indication).
Patients previously treated with alkylating agents (e.g., cyclophosphamide, melphalan, chlorambucil) are at substantially increased risk of malignancy if given Azathioprine, and combination should be avoided unless no alternative exists and the decision is made by a specialist (see Precautions and Warnings for additional cautions such as myelosuppression risk and use in pregnancy for other indications).
Frequently Asked Questions about Azathioprine
What is Azathioprine used for?
Azathioprine is an immunosuppressant medicine used mainly to help prevent rejection of a transplanted kidney and to treat moderate-to-severe rheumatoid arthritis that has not responded to other treatments. It is also used, under specialist guidance, for certain other autoimmune conditions such as inflammatory bowel disease and autoimmune hepatitis.
Do I need any tests before starting Azathioprine?
Yes. Testing for the enzymes TPMT and NUDT15 is recommended before starting Azathioprine, because people with low activity of these enzymes are at much higher risk of severe, potentially life-threatening drops in blood cell counts at standard doses. Your doctor will also check baseline blood counts and liver function.
Can I take allopurinol with Azathioprine?
Allopurinol significantly increases the levels and toxicity of Azathioprine by blocking the enzyme that breaks it down. If your doctor decides both medicines are needed together, the dose of Azathioprine must be reduced substantially (to about one-quarter to one-third of the usual dose) and your blood counts monitored closely. Never combine them without your doctor adjusting the dose.
Is Azathioprine safe during pregnancy or breastfeeding?
Azathioprine crosses the placenta and is classified as pregnancy category D; it should not be used in pregnant women being treated for rheumatoid arthritis. In other situations, such as transplant recipients, it may sometimes be continued in pregnancy only if a specialist decides the benefit clearly outweighs the risk, with close monitoring. Breastfeeding should only be done after your doctor has weighed the risks and benefits, since small amounts pass into breast milk. Always consult your physician before making any decision.
What side effects should prompt me to contact my doctor immediately?
Contact your doctor right away if you develop fever, unusual bruising or bleeding, signs of infection (sore throat, chills), yellowing of the skin or eyes, or severe abdominal pain while taking Azathioprine, as these may indicate serious bone marrow suppression, infection, or liver problems.
What happens if I miss a dose or take too much Azathioprine?
If you miss a dose, take it as soon as you remember unless it is almost time for the next dose; do not double the dose. If you or someone else has taken too much Azathioprine, seek immediate medical attention or contact emergency services/poison control, as overdose can cause severe suppression of blood cell production and other serious effects that require monitoring in a medical facility.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.