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Exposure of Women-Risk to Male Fetus: Dutasteride is absorbed through the skin. Therefore, women who are pregnant or may be pregnant should not handle Duagen (dutasteride) Soft Gelatin Capsules because of the possibility of absorption of dutasteride and the potential risk of a fetal anomaly to a male fetus (see CONTRAINDICATIONS). In addition, women should use caution whenever handling Duagen (dutasteride) Soft Gelatin Capsules.
General: Lower urinary tract symptoms of BPH can be indicative of other urological diseases, including prostate cancer. Patients should be assessed to rule out other urological diseases prior to treatment with Duagen (dutasteride) . Patients with a large residual urinary volume and/or severely diminished urinary flow may not be good candidates for 5α-reductase inhibitor therapy and should be carefully monitored for obstructive uropathy.
Blood Donation: Men being treated with dutasteride should not donate blood until at least 6 months have passed following their last dose. The purpose of this deferred period is to prevent administration of dutasteride to a pregnant female transfusion recipient.
Use in Hepatic Impairment: The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied. Because dutasteride is extensively metabolized and has a half-life of approximately 5 weeks at steady state, caution should be used in the administration of dutasteride to patients with liver disease.
Use with Potent CYP3A4 Inhibitors: Although dutasteride is extensively metabolized, no metabolically-based drug interaction studies have been conducted. The effect of potent CYP3A4 inhibitors has not been studied. Because of the potential for drug-drug interactions, care should be taken when administering dutasteride to patients taking potent, chronic CYP3A4 enzyme inhibitors (e.g., ritonavir).
Effects on PSA and Prostate Cancer Detection: Digital rectal examinations, as well as other evaluations for prostate cancer, should be performed on patients with BPH prior to initiating therapy with Duagen and periodically thereafter.
Dutasteride reduces total serum PSA concentration by approximately 40% following 3 months of treatment and 50% following 6 and 12 months of treatment. This decrease is predictable over the entire range of PSA values, although it may vary in individual patients. Therefore, for interpretation of serial PSAs in a man taking Duagen (dutasteride) , 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. To interpret an isolated PSA value in a man treated with Duagen (dutasteride) for 6 months or more, the PSA value should be doubled for comparison with normal values in untreated men.
Information for Patients
Physicians should instruct their patients to read the Information for Patient leaflet before starting therapy with Duagen (dutasteride) and to reread it upon prescription renewal for new information regarding the use of Duagen (dutasteride) .
Duagen (dutasteride) Soft Gelatin Capsules should not be handled by a woman who is 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 CONTRAINDICATIONS, and WARNINGS: Exposure Of Women†?Risk To Male Fetus).
Physicians should inform patients that ejaculate volume might be decreased in some patients durine treatment with Duagen (dutasteride) . This decrease does not appear to interfere with normal sexual function. In clinical trials, impotence and decreased libido, considered by the investigator to be drug-related, occurred in a small number of patients treated with Duagen (dutasteride) or placebo (5% and 3%, respectively, see ADVERSE REACTIONS).
Men treated with dutasteride should not donate blood until at least 6 months have passed following their last dose to prevent pregnant women from receiving dutasteride through blood transfusion (see PRECAUTIONS: Blood Donation).
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
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