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PROPECIA (FINASTERIDE): USE IN SPECIAL POPULATIONS

Pregnancy

Teratogenic Effects: Pregnancy Category X

Propecia is not indicated for use in women.

Administration of finasteride to pregnant rats on gestational days 6-20 at doses ranging from 100 mcg/kg/day to 100 mg/kg/day (1-684 times the human exposure, estimated) resulted in dose-dependent development of hypospadias in 3.6 to 100% of male offspring. Pregnant rats produced male offspring with decreased prostatic and seminal vesicular weights, delayed preputial separation, and transient nipple development when given finasteride at >= 30 mcg/kg/day (0.2 times the human exposure, estimated) and decreased anogenital distance when given finasteride at >= 3 mcg/kg/day (0.02 times the human exposure, estimated). The critical period during which these effects can be induced in male rats has been defined to be days 16-17 of gestation. The changes described above are expected pharmacological effects of drugs belonging to the class of Type II 5-alpha-reductase inhibitors and are similar to those reported in male infants with a genetic deficiency of Type II 5-alpha-reductase. No abnormalities were observed in female offspring exposed to any dose of finasteride in utero.

No developmental abnormalities have been observed in first filial generation (F1) male or female offspring resulting from mating finasteride-treated male rats (80 mg/kg/day; 488 times the human exposure) with untreated females. Administration of finasteride at 3 mg/kg/day (20 times the human exposure, estimated) during the late gestation and lactation period resulted in slightly decreased fertility in F1 male offspring. No effects were seen in female offspring.

No evidence of malformations has been observed in rabbit fetuses exposed to finasteride in utero from days 6-18 of gestation at doses up to 100 mg/kg/day (1908 times the recommended human dose of 1 mg/day, based on body surface area comparison). However, effects on male genitalia would not be expected since the rabbits were not exposed during the critical period of genital system development.

The in utero effects of finasteride exposure during the period of embryonic and fetal development were evaluated in the rhesus monkey (gestation days 20-100), a species more predictive of human development than rats or rabbits. Intravenous administration of finasteride to pregnant monkeys at doses up to 800 ng/day (at least 250 times the highest estimated exposure of pregnant women to finasteride from semen of men taking 1 mg/day, based on body surface area comparison) resulted in no abnormalities in male fetuses. In confirmation of the relevance of the rhesus model for human fetal development, oral administration of a 2 mg/kg/day dose of finasteride to pregnant monkeys resulted in external genital abnormalities in male fetuses. No other abnormalities were observed in male fetuses and no finasteride-related abnormalities were observed in female fetuses at any dose.

Nursing Mothers

Finasteride (Propecia) is not indicated for use in women.

It is not known whether finasteride is excreted in human milk.

Pediatric Use

Propecia tablets are not indicated for use in pediatric patients.

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical efficacy studies with Finasteride (Propecia) 1 mg tablets did not include subjects aged 65 and over. Based on the pharmacokinetics of finasteride 5 mg, no dosage adjustment is necessary in the elderly for Propecia. However the efficacy of this medication in the elderly has not been established.

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