Important Safety Information about AZASAN
WARNING: Chronic immunosuppression with this purine antimetabolite increases risk of
malignancy in humans. Reports of malignancy include post-transplant lymphoma and
hepatosplenic T-cell lymphoma (HSTCL) in patients with inflammatory bowel disease. 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. Physicians should inform patients
of the risk of malignancy with AZASAN. See WARNINGS.
(azathioprine tablets) 75/100 mg is indicated as an adjunct for the prevention of rejection in
renal homotransplantations, and also for the management of active rheumatoid arthritis to reduce
signs and symptoms. Patients are at increased risk of developing lymphoma and other malignancies,
particularly of the skin. Exposure to sunlight and ultraviolet light should be limited by wearing protective
clothing and a high SPF sunscreen. Patients should have complete blood count (CBC), including platelet
counts periodically during treatment. TPMT testing should be conducted to identify with absent or
reduced TPMT activity. The most commonly reported side effects associated with AZASAN therapy are
leukopenia and/or thrombocytopenia, secondary infections, neoplasia, nausea, vomiting, diarrhea,
fever, myalgias, skin rashes, and hepatotoxicity. AZASAN therapy should be given cautiously when used
concomitantly with allopurinol, ACE inhibitors, and other agents affecting myelopoiesis. Patients with
rheumatoid arthritis previously treated with alkylating agents (cyclophosphamide, chlorambucil,
melphalan, or others) may have a prohibitive risk of malignancy if treated with AZASAN. AZASAN is
contraindicated in pregnant and lactating women and in patients who have shown hypersensitivity to
Consult with your physician to see if this product is right for you.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.
For product information, adverse event reports, and product complaint reports, please contact:
Salix Product Information Call Center
Please see complete Prescribing Information for AZASAN, including BOXED WARNING.
The information contained on this page is intended for US residents, healthcare providers, and pharmacists only.