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Creatinine elevations occurred in 5. Use in Premenopausal Women. Aromasin is not indicated for the treatment of breast cancer in premenopausal women. Based on findings from animal studies and its mechanism of action, Aromasin can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of exemestane to pregnant rats and rabbits caused increased incidence of abortions and embryo-fetal toxicity. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Aromasin and for 1 month after the last dose [see Use in Specific Populations (8. In the adjuvant treatment of early breast cancer, the most common adverse reactions occurring in ?10% of patients in any treatment group (Aromasin vs. Discontinuation rates due to AEs were similar between Aromasin and tamoxifen (6. Incidences of cardiac ischemic events (myocardial infarction, angina, and myocardial ischemia) were Aromasin 1. Incidence of cardiac failure: Aromasin 0. In the treatment of advanced breast cancer, the most common adverse reactions were mild to moderate and included hot flushes (13% vs. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect exposure to Aromasin in 2325 postmenopausal women with early breast cancer. Aromasin tolerability in postmenopausal women with early breast cancer was evaluated in two well-controlled trials: the IES study [See Clinical Studies (14. The median duration of adjuvant treatment was 27. Median duration of observation after randomization for Aromasin was 34. Median duration of observation was 30 months for both groups in the 027 study. Certain adverse reactions, which were expected based on the known pharmacological properties and side effect profiles of test drugs, were actively sought through a positive checklist. Signs and symptoms were graded for severity using CTC in both studies. Within the IES study, the presence of some illnesses/conditions was monitored through a positive checklist without assessment of severity. These included myocardial infarction, other cardiovascular disorders, gynecological disorders, osteoporosis, osteoporotic fractures, other primary cancer, and hospitalizations. Within the IES study, discontinuations due to adverse reactions occurred in 6. Deaths due to any cause were reported for 1. There were 6 deaths due to stroke on the exemestane arm compared to 2 on tamoxifen, undecanoate 250 mg injectable steroids $46.00 nebido.
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