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Therefore, Avodart may cause fetal harm when administered to a pregnant woman. Patients should be assessed to rule out prostate cancer and other urological diseases prior to treatment with Avodart and periodically thereafter. During the first 2 years, 1,623 subjects received monotherapy with Avodart; 1,611 subjects received monotherapy with tamsulosin; and 1,610 subjects received combination therapy. Therefore, for interpretation of serial PSAs in a man taking Avodart, a new baseline PSA concentration should be established after 3 to 6 months of treatment, and this new value should be used to assess potentially cancer-related changes in PSA. If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men receiving Avodart, no adjustment to its value appears necessary. When including the open-label extensions, 1,009 male subjects were exposed to Avodart for 3 years and 812 were exposed for 4 years.

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