Propecia Adverse Reactions

Clinical Studies for Propecia (finasteride 1 mg) in the Treatment of Male Pattern Hair Loss

In controlled clinical trials for Propecia of 12-month duration, 1.4% of the patients were discontinued due to adverse experiences that were considered to be possibly, probably or definitely drug-related (1.6% for placebo); 1.2% of patients on Propecia and 0.9% of patients on placebo discontinued therapy because of a drug-related sexual adverse experience. The following clinical adverse reactions were reported as possibly, probably or definitely drug-related in >/=1% of patients treated for 12 months with Propecia or placebo, respectively: decreased libido (1.8%, 1.3%), erectile dysfunction (1.3%, 0.7%) and ejaculation disorder (1.2%, 0.7%; primarily decreased volume of ejaculate:[0.8%, 0.4%]). Integrated analysis of clinical adverse experiences showed that during treatment with Propecia , 36 (3.8%) of 945 men had reported one or more of these adverse experiences as compared to 20 (2.1%) of 934 men treated with placebo (p=0.04). Resolution occurred in all men who discontinued therapy with Propecia due to these side effects and in most of those who continued therapy. 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. Two other studies showed that finasteride at 5 times the dosage of Propecia (5 mg daily) produced significant median decreases of approximately 0.5 mL (-25%) compared to placebo in ejaculate volume but this was reversible after discontinuation of treatment.

In the clinical studies with Propecia , the incidences for breast tenderness and enlargement, hypersensitivity reactions, and testicular pain in finasteride-treated patients were not different from those in patients treated with placebo.

Postmarketing Experience for Propecia (finasteride 1 mg)

Breast tenderness and enlargement; hypersensitivity reactions including rash, pruritus, urticaria, and swelling of the lips and face; and testicular pain.

Controlled Clinical Trials and Long-Term Open Extension Studies for PROSCAR* (finasteride 5 mg) in the Treatment of Benign Prostatic Hyperplasia

In controlled clinical trials for PROSCAR of 12-month duration, 1.3% of the patients were discontinued due to adverse experiences that were considered to be possibly, probably or definitely drug-related (0.9% for placebo); only one patient on PROSCAR (0.2%) and one patient on placebo (0.2%) discontinued therapy because of a drug-related sexual adverse experience. The following clinical adverse reactions were reported as possibly, probably or definitely drug-related in >/=1% of patients treated for 12 months with PROSCAR or placebo, respectively: erectile dysfunction (3.7%, 1.1%), decreased libido (3.3%, 1.6%) and decreased volume of ejaculate (2.8%, 0.9%). The adverse experience profiles for patients treated with finasteride 1 mg/day for 12 months and those maintained on PROSCAR for 24 to 48 months were similar to that observed in the 12-month controlled studies with PROSCAR. Sexual adverse experiences resolved with continued treatment in over 60% of patients who reported them.

Propecia Overdosage

In clinical studies, single doses of finasteride up to 400 mg and multiple doses of finasteride up to 80 mg/day for three months did not result in adverse reactions. Until further experience is obtained, no specific treatment for an overdose with finasteride can be recommended.

Significant lethality was observed in male and female mice at single oral doses of 1,500 mg/m ² (500 mg/kg) and in female and male rats at single oral doses of 2,360 mg/m ² (400 mg/kg) and 5,900 mg/m ² (1,000 mg/kg), respectively.

Propecia Dosage and Administration

The recommended dosage is 1 mg once a day.

Propecia may be administered with or without meals.

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

How Supplied

No. 6642--Propecia tablets, 1 mg, are tan, octagonal, film-coated convex tablets with "stylized P" on one side and Propecia on the other. They are supplied as follows:

NDC 0006-0071-31 unit of use bottles of 30

NDC 0006-0071-61 ProPak® *** - carton of 3 unit of use bottles of 30.

Storage and Handling

Store at room temperature, 15-30°C (59-86°F). Keep container closed and protect from moisture.

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 are not broken or crushed.