Do not donate blood until at least 6 mth following last dose. Increased risk of high-grade prostate cancer. Effect on semen characteristics. Men at risk of obstructive uropathy. Establish a new PSA baseline at least 3 mth after starting treatment & periodically monitor thereafter to interpret serial PSAs. Evaluate for other urological diseases prior to treatment & for prostatic carcinoma prior to & during therapy. Hepatic impairment. Contraindicated in women. Possibility of reduced male fertility. Woman who is pregnant or who could become pregnant should not handle tab & should avoid exposure to partner's semen.