Establish new prostate-specific antigen (PSA) baseline at least 3 mth after starting treatment & monitor PSA periodically thereafter during therapy. Increased risk of high-grade prostate cancer development. Consider for other urological conditions that may cause similar symptoms prior to initiation of treatment. Should not be handled by pregnant women or women of childbearing potential. Men should not donate blood until at least 6 mth following last dose. Lactation.