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AVODART (DUTASTERIDE) CAPSULES: PATIENT COUNSELING INFORMATION

PSA Monitoring

Physicians should inform patients that Avodart (Dutasteride) reduces serum PSA levels by approximately 50% within 3 to 6 months of therapy, although it may vary for each individual. For patients undergoing PSA screening, increases in PSA levels while on treatment with Avodart may signal the presence of prostate cancer and should be evaluated by a healthcare provider.

Increased risk of high-grade prostate cancer

Physicians should inform patients that there was an increase in high-grade prostate cancer in men treated with 5 alpha-reductase inhibitors (which are indicated for BPH treatment), including Avodart (Dutasteride), compared with those treated with placebo in studies looking at the use of these drugs to reduce the risk of prostate cancer.

Exposure of women risk to male fetus

Physicians should inform patients that Dutasteride (Avodart) capsules should not be handled by a woman who is pregnant or who could become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus. Dutasteride is absorbed through the skin and could result in unintended fetal exposure. If a pregnant woman or woman of childbearing potential comes in contact with leaking Avodart capsules, the contact area should be washed immediately with soap and water.

Blood donation

Physicians should inform men treated with Avodart (Dutasteride) that they should not donate blood until at least 6 months following their last dose to prevent pregnant women from receiving dutasteride through blood transfusion. Serum levels of dutasteride are detectable for 4 to 6 months after treatment ends.

Manufactured and distributed by GlaxoSmithKline pharmaceutical company and its divisions.

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