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AVODART: WARNINGS AND PRECAUTIONS
Effects on Prostate-Specific Antigen (PSA) and the use of PSA in prostate cancer detection
In clinical studies, Avodart (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 patients with symptomatic BPH, although it may vary in individuals. This medication may also cause decreases in serum PSA in the presence of prostate cancer. To interpret serial PSAs in men taking Avodart, a new PSA baseline should be established at least 3 months after starting treatment and PSA monitored periodically thereafter. Any confirmed increase from the lowest PSA value while on Dutasteride may signal the presence of prostate cancer and should be evaluated, even if PSA levels are still within the normal range for men not taking a 5-alpha-reductase inhibitor. Noncompliance with this medicine may also affect PSA test results.
To interpret an isolated PSA value in a man treated with Avodart for 3 months or more, the PSA value should be doubled for comparison with normal values in untreated men.
The free-to-total PSA ratio (percent free PSA) remains constant, even under the influence of Avodart. 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.
Coadministration of dutasteride and tamsulosin resulted in similar changes to serum PSA as dutasteride monotherapy.
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 Avodart 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 (Avodart 1.0% versus placebo 0.5%. In a 7-year placebo-controlled clinical trial with another 5-alpha-reductase inhibitor (Proscar, Finasteride 5 mg), similar results for Gleason score 8-10 prostate cancer were observed (finasteride 1.8% versus placebo 1.1%).
5-Alpha-reductase inhibitors may increase the risk of development of high-grade prostate cancer. Whether the effect of 5-alpha-reductase inhibitors to reduce prostate volume, or study related factors, impacted the results of these studies has not been established.
Evaluation for other urological diseases
Lower urinary tract symptoms of BPH can be indicative of other urological diseases, including prostate cancer. Patients should be assessed to rule out prostate cancer and other urological diseases prior to treatment with Avodart (Dutasteride) and periodically thereafter.
Exposure of women - risk to male fetus
This medciation in capsules should not be handled by a woman who is pregnant or who could become pregnant. Dutasteride (Avodart) 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.
Men being treated with Avodart 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 0.5 mg per day on semen characteristics were evaluated in normal volunteers aged 18 to 52 (n = 27 dutasteride, n = 23 placebo) throughout 52 weeks of treatment and 24 weeks of post-treatment follow-up. At 52 weeks, the mean percent reductions from baseline in total sperm count, semen volume, and sperm motility were 23%, 26%, and 18%, respectively, in the dutasteride group when adjusted for changes from baseline in the placebo group. Sperm concentration and sperm morphology were unaffected. After 24 weeks of follow-up, the mean percent change in total sperm count in the dutasteride group remained 23% lower than baseline. While mean values for all semen parameters at all time-points remained within the normal ranges and did not meet predefined criteria for a clinically significant change (30%), 2 subjects in the dutasteride group had decreases in sperm count of greater than 90% from baseline at 52 weeks, with partial recovery at the 24-week follow-up. The clinical significance of dutasteride's effect on semen characteristics for an individual patient's fertility is not known.
Avodart (Dutasteride) related pharmaceutical drugs and medications
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