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| 5-Year Data |
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See the results of the longest reported controlled clinical study of male pattern hair loss. |
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| View study results. |
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| Timeline for Results |
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| At 3 months ... |
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Patients may see decreased hair loss. |
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— PROPECIA® (finasteride) is available in the 90-day PROPAK®* to get patients started. |
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| At 6 months ... |
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Patients may see new hair growth. |
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| At 12 months ... |
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Patients have completed the recommended trial period and may see improvement. |
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Further treatment is unlikely to be of benefit if the drug has not worked within 12 months. |
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Stopping treatment leads to a gradual reversal of the beneficial effects within 12 months. |
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| At 5 years ... |
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Most (65%) of the men treated with PROPECIA had increased hair count from baseline. |
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All of the men in the placebo group had decreased hair count from baseline. |
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Stopping treatment leads to a gradual reversal of the beneficial effects within 12 months. |
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| Important Information About PROPECIA |
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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. |
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PROPECIA is not indicated in women or children. |
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No dosage adjustment is necessary in the elderly or in patients with renal insufficiency. |
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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. |
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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. |
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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. |
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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. |
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If PROPECIA has not maintained hair count or regrown visible hair within 12 months, further treatment is unlikely to be of benefit. |
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