Dutasia 0.5 Special Precautions

Effects on Prostate-Specific Antigen (PSA) and the Use of PSA in Prostate Cancer Detection: Dutasteride reduced serum PSA concentration by approximately 50% within 3 to 6 months of treatment. This decrease was predictable over the entire range of PSA values in subjects with symptomatic BPH, although it may vary in individuals. Dutasteride may also cause decreases in serum PSA in the presence of prostate cancer.
Increased Risk of High-Grade Prostate Cancer: In men aged 50 to 75 years with a prior negative biopsy for prostate cancer and a baseline PSA between 2.5 ng/mL and 10.0 ng/mL taking Dutasteride in the 4-year Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial, there was an increased incidence of Gleason score 8-10 prostate cancer compared with men taking placebo (Dutasteride 1.0% versus placebo 0.5%). 5-Alpha Reductase Inhibitors may increase the risk of development of high-grade prostate cancer.
Evaluation for Other Urological Diseases: Prior to initiating treatment with Dutasteride, consideration should be given to other urological conditions that may cause similar symptoms. In addition, BPH and prostate cancer may coexist.
Exposure of Women-Risk to Male Fetus: Dutasteride should not be handled by a woman who is pregnant or who could become pregnant. Dutasteride is absorbed through the skin and could result in unintended fetal exposure. If a woman who is pregnant or who could become pregnant comes in contact with leaking Dutasteride capsules, the contact area should be washed immediately with soap and water.
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.
Effect on Semen Characteristics: The effects of Dutasteride 500 mcg/day on semen characteristics for an individual patient's fertility is not known.
Renal Impairment: No dose adjustment is necessary for Dutasteride in patients with renal impairment.
Hepatic Impairment: The effect of hepatic impairment on Dutasteride pharmacokinetics has not been studied. Because Dutasteride is extensively metabolized, exposure could be higher in hepatically impaired patients.
Use in Children: Dutasteride is contraindicated for use in pediatric patients. Safety and effectiveness in pediatric patients have not been established.
Use in Elderly: No overall differences in safety or efficacy were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.