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Limited data in subjects with severe hepatic impairment suggest that excretion of Casodex may be delayed and could lead to further ***. Casodex may cause fetal harm when administered to pregnant women. Hence, caution should be exercised when Casodex is co-administered with CYP 3A4 substrates. Hepatitis or marked increases in liver enzymes leading to drug discontinuation occurred in approximately 1% of Casodex patients in controlled clinical trials. However, in clinical trials with Casodex as a single agent for prostate cancer, rises in serum testosterone and estradiol have been noted. If PSA levels rise during Casodex therapy, the patient should be evaluated for clinical progression.
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