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5-mg daily doses of Avodart in 3 identical 2-year, placebo-controlled, double-blind, Phase 3 treatment studies, each with 2-year open-label extensions. Avodart Capsules should not be handled by women who are pregnant or who may become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus [see Warnings and Precautions (5. 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. Because of the potential for drug-drug interactions, use caution when prescribing Avodart to patients taking potent, chronic CYP3A4 enzyme inhibitors (e.

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