Dutasteride

Carefully monitor patients with a large residual urinary volume or severely diminished urinary flow for obstructive uropathy; these patients may not be candidates for dutasteride therapy.

Use with caution in patients with hepatic impairment.

When compared to placebo, 5-alpha-reductase inhibitors (5-ARIs) have been shown to reduce the overall incidence of prostate cancer, although an increase in the incidence of high-grade prostate cancers has been observed; 5-ARIs are not approved in the US or Canada for the prevention of prostate cancer. Concurrent drug therapy issues:

Use with caution with concurrent use of potent, chronic CYP3A4 inhibitors. Special handling:

Active ingredient can be absorbed through the skin; women should always use caution whenever handling. Pregnant women or women trying to conceive should not handle the product; if contact with a leaking capsule occurs, wash area immediately with soap and water; dutasteride may negatively impact fetal development. Other warnings/precautions:

Other urological diseases, including prostate cancer, should be ruled out before initiating therapy.

Avoid donating blood during or for 6 months following treatment cessation due to risk of administration to a pregnant female transfusion recipient.

Reduces prostate specific antigen (PSA) by ~50% within 3-6 months of use. If following serial PSAs, re-establish a new baseline ≥3 months after treatment initiation; monitor PSA periodically thereafter. If interpreting an isolated PSA value in a patient treated for ≥3 months, then double the PSA value for comparison to a normal PSA value in an untreated man. PSA increases while on dutasteride should be considered suspicious; obtain serial PSA measurements and evaluate (Andriole, 2006). Patients on a 5-ARI with any increase in PSA levels, even if within normal limits, should be evaluated; may indicate presence of prostate cancer.