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Finasteride Pharmaceutical-Formulations

HOME >> API >> API List1 >> Finasteride >> Precautions

PRECAUTIONS
Finasteride CAS number 98319-26-7

Prior to initiating therapy with Finasteride, appropriate evaluation should be performed to identify other conditions such as infection, prostate cancer, stricture disease, hypotonic bladder or other neurogenic disorders that might mimic BPH.

Patients with large residual urinary volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy. These patients may not be candidates for Finasteride therapy.

Caution should be used in the administration of Finasteride in those patients with liver function abnormalities, as Finasteride is metabolized extensively in the liver.
Effects on PSA and Prostate Cancer Detection
No clinical benefit has been demonstrated in patients with prostate cancer treated with Finasteride. Patients with BPH and elevated PSA were monitored in controlled clinical studies with serial PSAs and prostate biopsies. In these BPH studies, Finasteride did not appear to alter the rate of prostate cancer detection, and the overall incidence of prostate cancer was not significantly different in patients treated with Finasteride or placebo.

Finasteride causes a decrease in serum PSA levels by approximately 50% in patients with BPH, even in the presence of prostate cancer. This decrease is predictable over the entire range of PSA values, although it may vary in individual patients. Analysis of PSA data from over 3000 patients in a long-term efficacy and safety study confirmed that in typical patients treated with Finasteride for six months or more, PSA values should be doubled for comparison with normal ranges in untreated men. This adjustment preserves the sensitivity and specificity of the PSA assay and maintains its ability to detect prostate cancer.

Any sustained increases in PSA levels while on Finasteride should be carefully evaluated, including consideration of non-compliance to therapy with Finasteride.

Percent free PSA (free to total PSA ratio) is not significantly decreased by Finasteride. The ratio of free to total PSA remains constant even under the influence of Finasteride. If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men undergoing Finasteride therapy, no adjustment to its value appears necessary.

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