Finstal-5 Special Precautions

General: The beneficial response of Finasteride may not be manifested immediately and thus patients with large residual urine volume and/or severely diminished urinary flow should be monitored carefully for obstructive neuropathy. Since serum markers of prostate cancer may be reduced in patients taking Finasteride, such malignancies should be excluded before treatment of benign prostatic hyperplasia is initiated.
Effects of PSA and prostate cancer detection: No clinical benefit has been demonstrated in patients with prostate cancer treated with Finasteride. Digital rectal examinations as well as other evaluations for prostate cancer are recommended prior to initiating therapy with Finasteride and periodically thereafter. Serum prostate-specific antigen (S-PSA) is also used for prostate cancer detection.
Generally, a baseline S-PSA greater than 10 ng/mL prompts further evaluation and consideration of biopsy; for S-PSA levels between 4 and 10 ng/mL, further evaluation and consideration of biopsy; for S-PSA <4 ng/mL does not exclude prostate cancer.
Finasteride causes a decrease in S-PSA concentrations even in the presence of prostate cancer. The reduction of levels in patients with BPH treated with Finasteride should be considered when evaluating S-PSA data and does not rule out concomitant prostate cancer. Patients treated with Finasteride who have a sustained increase in S-PSA levels should be carefully evaluated.