How does PROPECIA work?

PROPECIA significantly reduces DHT, a key cause of hair loss, by inhibiting the formation of DHT in your scalp.

Lowering DHT appears to inhibit the further shrinking of affected hair follicles.

DHT is a substance in the body that can shrink the hair follicle until it no longer produces visible hair. Scientists believe DHT and family history are key factors in hair loss.

How long do I need to take PROPECIA?

You need to take PROPECIA for as long as you want to grow or maintain your hair. 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. 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.

Will I grow natural-looking hair?

PROPECIA grows natural hair, not just "peach fuzz." A 4-year study¹ showed that hair grew in thicker and/or faster with PROPECIA. At the end of this study, there was an increase in the weight of hair samples taken from men who took PROPECIA compared with hair samples from men who took placebo. The effectiveness of PROPECIA was demonstrated in studies of men, aged 18 to 41 years, with mild to moderate hair loss at the top and middle front of the head. There is not sufficient evidence that PROPECIA works for receding hairlines at the temples.

If my wife and I conceive a child while I'm taking PROPECIA, does PROPECIA pose a risk to the child's development? If my wife and I have intercourse after she is pregnant, does PROPECIA pose a risk to the baby?

Available data indicate that the level of PROPECIA in the semen of a man taking PROPECIA does not pose a risk to an unborn child.

PROPECIA is for the treatment of male pattern hair loss in MEN ONLY and should NOT be used by women or children.

Women who are or may potentially be pregnant must not use PROPECIA and should not handle crushed or broken tablets of PROPECIA because the active ingredient may cause abnormalities of a male baby’s sex organs. If a woman who is pregnant comes into contact with the active ingredient in PROPECIA, a doctor should be consulted. PROPECIA tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.

Will I grow hair on places other than my head?

No. In a clinical study, PROPECIA did not appear to affect hair growth on other parts of the body.

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.