Consumer medicine information

1. Why am I using APO-Azathioprine?

APO-Azathioprine contains the active ingredient azathioprine. APO-Azathioprine is used to help prevent the body from rejecting transplanted organs such as the heart or kidney.
For more information, see Section 1. Why am I using APO-Azathioprine? in the full CMI.

2. What should I know before I use APO-Azathioprine?

Do not use it if you have ever had an allergic reaction to azathioprine or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use APO-Azathioprine? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APO-Azathioprine and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use APO-Azathioprine?

• Take his medicine at about the same time each day. Taking at the same time each day will have the best effect. It will also help you remember when to take it.

• Take this medicine at least one hour before or three hours after food or milk.

5. What should I know while using APO-Azathioprine?

6. Are there any side effects?

The common side effects include any infection or fever, unexpected bruising or bleeding, black stools or blood in the urine or stools, new marks on skin or any change to marks that may have been there previously, headache, stiff neck and extreme sensitivity to bright light, nausea and vomiting, tiredness, dizziness or generally unwell, irregular heartbeat, sores in the mouth and on the lips, change in sense of smell or taste.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Azathioprine.

2 Qualitative and Quantitative Composition

Each tablet contains 25 mg or 50 mg azathioprine as the active ingredient.
Excipients with known effect. Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

APO-Azathioprine 25 mg tablets. Orange coloured, round, biconvex film coated tablet with "AZA 25" embossed on one side and break line on other side.
APO-Azathioprine 50 mg tablets. Pale yellow coloured, round, biconvex film coated tablet with "AZA 50" embossed on one side and break line on other side.
Azathioprine tablets should not be divided, crushed or broken.
Provided that the film coating is intact, there is no risk in handling film coated tablets.

4 Clinical Particulars

4.9 Overdose

Signs. Unexplained infection, ulceration of the throat, bruising and bleeding are the main signs of overdosage with azathioprine and result from bone marrow depression which may be maximal after 9-14 days. These signs are more likely to be manifest following chronic overdosage, rather than after a single acute overdose. Occasional reports describe ingestion of from 0.5-7.5 g azathioprine on a single occasion with apparent uneventful recovery.
Treatment. Treatment is symptomatic and has included gastric lavage. If overdosage occurs the blood picture and hepatic function in particular should be monitored. Azathioprine is dialysable but the procedure is of doubtful value since azathioprine is rapidly metabolised with entry of metabolites into tissue cells.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Chromosomal abnormalities, which can occur independently of the influence of azathioprine, have been demonstrated in both male and female transplant recipients.
Chromosomal abnormalities which disappear in time have been demonstrated in offspring of transplant recipients. Except in extremely rare cases, no overt physical evidence of abnormality has been observed in these offspring.
Azathioprine and long wave ultraviolet light have been shown to have a synergistic clastogenic effect in patients treated with azathioprine for a range of disorders.
Carcinogenicity (see Section 4.8 Adverse Effects (Undesirable Effects)). Patients receiving immunosuppressive therapy, including azathioprine, are at an increased risk of developing lymphoproliferative disorders and other malignancies, notably skin cancers (melanoma and non-melanoma), sarcomas (Kaposi's and non-Kaposi's) and uterine cervical cancer in situ. The increased risk appears to be related to the degree and duration of immunosuppression.
It has been reported that discontinuation of immunosuppression may provide partial regression of the lymphoproliferative disorder. A treatment regimen containing multiple immunosuppressants (including thiopurines) should there be used with caution as this could lead to lymphoproliferative disorders, some with reported fatalities. A combination of multiple immunosuppressants, given concomitantly, increases the risk of Epstein-Barr virus (EBV)-associated lymphoproliferative disorders. Patients receiving multiple immunosuppressive agents may be at risk of over immunosuppression, therefore such therapy should be maintained at the lowest effective level. As is usual for patients with increased risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Renal transplant recipients in some geographical areas are at great risk of skin cancers than those in other areas.
Other neoplasms reportedly associated with azathioprine include carcinoma of the urinary bladder and adenocarcinoma of the lung (see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)).

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Azathioprine is a pale yellow powder, practically insoluble in water and in alcohol. It is soluble in dilute solutions of alkali hydroxides and sparingly soluble in dilute mineral acids.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSAZATHI.gif Chemical name: 6-[(1-methyl-4-nitro-1H-imidazol-5-yl)sulfanyl]-7-H-purine.
Molecular formula: C₉H₇N₇O₂S.
Molecular weight: 277.3.
CAS number. 446-86-6.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/APOAZAST.gif