AZASAN is indicated as an adjunct for the prevention of rejection in renal homotransplantations and to reduce signs and symptoms of severe active rheumatoid arthritis. Immunosuppressants such as azathioprine are effective in helping to control the inflammatory process and thus reducing the need for chronic steroid treatment and its related adverse events.
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.
AZASAN® (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 this product.
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