PROPECIA lowers DHT

PROPECIA, a once-a-day pill, is a specific inhibitor of type II 5 alpha-reductase that lowers dihydrotestosterone (DHT). (The relative contributions of these reductions to the treatment effect of PROPECIA have not been defined.)

Lowering DHT appears to:

• Inhibit the further miniaturization of affected hair follicles
• Help restore miniaturized hair follicles to regrow visible hair

In a clinical study, PROPECIA did not appear to affect hair growth on other parts of the body.

PROPECIA slows progression

• In a 5-year clinical study of men with MPHL, 100% of men treated with placebo lost hair based on hair count at 5 years vs their baseline hair count.¹
• 5 years of clinical data with PROPECIA showed the benefits of treating hair loss earlier.¹
• Men who started treatment with placebo and were switched to PROPECIA 1 year later never caught up to men who were treated with PROPECIA for the full 5 years based on hair count.¹

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.

Important 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.

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.

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%. These findings should be taken into account for proper interpretation of serum PSA when evaluating men treated with finasteride.

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 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.

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. The Patient Information also is available.