PROPECIA is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY. Safety and efficacy were demonstrated in men between 18 and 41 years of age 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 About PROPECIA

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.

PROPECIA is contraindicated in patients with hypersensitivity to any component of this medication.

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.

Men aged 55 and over with a normal digital rectal examination and PSA <3.0 ng/mL at baseline taking finasteride 5 mg/day (5 times the dose of PROPECIA) in the 7-year Prostate Cancer Prevention Trial (PCPT) had an increased risk of Gleason score 8-10 prostate cancer (finasteride 1.8% vs placebo 1.1%). Similar results were observed in a separate 4-year placebo-controlled clinical trial with another 5α-reductase inhibitor. 5α-reductase inhibitors may increase the risk of development of high-grade prostate cancer. Whether the effect of 5α-reductase inhibitors to reduce prostate volume, or study-related factors, impacted the results of these studies has not been established.

In clinical studies with PROPECIA (finasteride, 1 mg) in men 18-41 years of age, 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. Further, 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 increase from the lowest PSA value while on PROPECIA may signal the presence of prostate cancer and should be evaluated, even if PSA levels are still within the normal range for men not taking a 5α-reductase inhibitor. Non-compliance to therapy with PROPECIA may also affect PSA test results.

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 double-blind, placebo-controlled 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; depression; hypersensitivity reactions including rash, pruritus, urticaria, and swelling of the lips and face; testicular pain; erectile dysfunction that continued after discontinuation of treatment; and male breast cancer.

During the 4- to 6-year placebo- and comparator-controlled Medical Therapy of Prostatic Symptoms (MTOPS) study that enrolled 3047 men, there were 4 cases of breast cancer in men treated with PROSCAR but no cases in men not treated with PROSCAR. During the 4-year placebo-controlled PLESS study that enrolled 3040 men, there were 2 cases of breast cancer in placebo-treated men but no cases in men treated with PROSCAR. During the 7-year placebo-controlled Prostate Cancer Prevention Trial (PCPT) that enrolled 18,882 men, there was 1 case of breast cancer in men treated with PROSCAR, and 1 case of breast cancer in men treated with placebo. The relationship between long-term use of finasteride and male breast neoplasia is currently unknown.

The PCPT trial was a 7-year randomized, double-blind, placebo-controlled trial that enrolled 18,882 healthy men >55 years of age with a normal digital rectal examination and a PSA <3.0 ng/mL. Men received either PROSCAR (finasteride 5 mg) or placebo daily. Patients were evaluated annually with PSA and digital rectal exams. Biopsies were performed for elevated PSA, an abnormal digital rectal exam, or the end of study. The incidence of Gleason score 8-10 prostate cancer was higher in men treated with finasteride (1.8%) than in those treated with placebo (1.1%). In a separate 4-year placebo-controlled clinical trial with another 5α-reductase inhibitor, similar results for Gleason score 8-10 prostate cancer were observed. The clinical significance of these findings with respect to use of PROPECIA by men is unknown.

The recommended dosage is 1 mg orally once a day.

In general, daily use for 3 months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be reevaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months.

If PROPECIA has not maintained hair count or regrown visible hair within 12 months, further treatment is unlikely to be of benefit. Withdrawal of treatment leads to reversal of effect within 12 months.

No dosage adjustment is necessary in the elderly or in patients with renal insufficiency.

Before prescribing PROPECIA, please read the Prescribing Information.