PROPECIA is the first oral therapy indicated for the treatment of male pattern hair loss in MEN ONLY. Safety and efficacy were demonstrated in men, aged 18 to 41, with mild to moderate hair loss of the vertex and anterior mid-scalp area. Efficacy in bitemporal recession has not been established.

PROPECIA is not indicated in women or children.

Selected Safety Information

PROPECIA is contraindicated in women when they are or may potentially be pregnant. Finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant woman.

Women should not handle crushed or broken PROPECIA tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. PROPECIA tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed.

Caution should be used in patients with liver function abnormalities, as finasteride is metabolized extensively in the liver.

Physicians should instruct their patients to promptly report any changes in their breasts such as lumps, pain, or nipple discharge. Breast changes including breast enlargement, tenderness, and neoplasm have been reported.

Physicians should instruct their patients to read the patient package insert before starting therapy with PROPECIA and to read it again each time the prescription is renewed so that they are aware of current information for patients regarding PROPECIA.

In clinical studies with finasteride 1 mg in men aged 18 to 41, the mean value of serum prostate-specific antigen (PSA) decreased from 0.7 ng/mL at baseline to 0.5 ng/mL at Month 12. In clinical studies with PROSCAR^® (finasteride, 5 mg) when used in older men who have benign prostatic hyperplasia (BPH), PSA levels are decreased by approximately 50%. Other studies with PROSCAR showed it may also cause decreases in serum PSA in the presence of prostate cancer. These findings should be taken into account for proper interpretation of serum PSA when evaluating men treated with finasteride. Any confirmed increases in PSA levels from nadir while on PROPECIA may signal the presence of prostate cancer and should be carefully evaluated, even if those values are still within the normal range for men not taking a 5α-reductase inhibitor. Non-compliance to therapy with PROPECIA may also affect PSA results.

No drug interactions of clinical importance have been identified.

In 3 clinical studies of 1 year for PROPECIA, 1.6% of patients in the placebo group discontinued therapy due to drug-related adverse events vs 1.4% of patients treated with PROPECIA.

In clinical studies of 1 year for PROPECIA, each drug-related sexual adverse event occurred in less than 2% of men. Discontinuation due to drug-related sexual adverse experiences was 1.2% in the group treated with PROPECIA and 0.9% in the placebo-treated group. Reported drug-related sexual adverse experiences included decreased libido (1.8% vs 1.3 %, placebo), erectile dysfunction (1.3% vs 0.7%, placebo), and ejaculation disorders (1.2% vs 0.7%, placebo), primarily decreased volume of ejaculate (0.8% vs 0.4%, placebo).

Resolution occurred in the 1-year studies in men who discontinued therapy with PROPECIA due to these sexual side effects.

The incidence of each of the above side effects decreased to <0.3% by the fifth year of treatment with PROPECIA.

In a study of finasteride 1 mg daily in healthy men, a median decrease in ejaculate volume of 0.3 mL (–11%) compared with 0.2 mL (–8%) for placebo was observed after 48 weeks of treatment.

In postmarketing experience, the following adverse events have been reported: breast tenderness and enlargement; hypersensitivity reactions including rash, pruritus, urticaria, and swelling of the lips and face; and testicular pain.

The relationship between long-term use of finasteride and male breast neoplasia is currently unknown. During a 4- to 6-year placebo- and comparator-controlled study involving PROSCAR^® (finasteride) that enrolled 3,047 men, there were 4 cases of breast cancer in men treated with PROSCAR but no cases in men not treated with PROSCAR. In another 4-year placebo-controlled study involving PROSCAR that enrolled 3,040 men, there were 2 cases of breast cancer in placebo-treated men, but no cases were reported in men treated with PROSCAR.

In a 7-year placebo-controlled trial involving PROSCAR^® (finasteride) that enrolled 18,882 healthy men, 9,060 had prostate needle biopsy data available for analysis. In the group treated with PROSCAR, 280 (6.4%) men had prostate cancer with Gleason scores of 7 to 10 detected on needle biopsy vs 237 (5.1%) men in the placebo group. Of the total cases of prostate cancer diagnosed in this study, approximately 98% were classified as intracapsular (Stage T1 or T2). The clinical significance of these findings is unknown. This information from the literature (Thompson IM, Goodman PJ, Tangen CM, et al. The influence of finasteride on the development of prostate cancer. N Engl J Med. 2003;349:213–222) is provided for consideration by physicians when PROSCAR is used as indicated. PROSCAR is not approved to reduce the risk of developing prostate cancer.