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AVODART: USE IN SPECIFIC POPULATIONS
Pregnancy category X. This drug is contraindicated for use in women of childbearing potential and during pregnancy. Avodart (Dutasteride) is a 5-alpha-reductase inhibitor that prevents conversion of testosterone to dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia. In animal reproduction and developmental toxicity studies, dutasteride inhibited normal development of external genitalia in male fetuses. Therefore, Avodart may cause fetal harm when administered to a pregnant woman. If this medicine is used during pregnancy or if the patient becomes pregnant while taking Avodart, the patient should be apprised of the potential hazard to the fetus.
Abnormalities in the genitalia of male fetuses is an expected physiological consequence of inhibition of the conversion of testosterone to DHT by 5-alpha-reductase inhibitors. These results are similar to observations in male infants with genetic 5-alpha-reductase deficiency. Dutasteride is absorbed through the skin. To avoid potential fetal exposure, women who are pregnant or could become pregnant should not handle Avodart capsules. If contact is made with leaking capsules, the contact area should be washed immediately with soap and water. Dutasteride is secreted into semen. The highest measured semen concentration of dutasteride in treated men was 14 ng / mL. Assuming exposure of a 50-kg woman to 5 ml of semen and 100% absorption, the woman's dutasteride concentration would be about 0.0175 ng / mL. This concentration is more than 100 times less than concentrations producing abnormalities of male genitalia in animal studies. Avodart is highly protein bound in human semen (greater than 96%), which may reduce the amount of dutasteride available for vaginal absorption.
In an embryo-fetal development study in female rats, oral administration of dutasteride at doses 10 times less than the maximum recommended human dose (MRHD) of 0.5 mg daily resulted in abnormalities of male genitalia in the fetus (decreased anogenital distance at 0.05 mg / kg / day), nipple development, hypospadias, and distended preputial glands in male offspring (at all doses of 0.05, 2.5, 12.5, and 30 mg / kg per day). An increase in stillborn pups was observed at 111 times the MRHD, and reduced fetal body weight was observed at doses of about 15 times the MRHD (animal dose of 2.5 mg / kg per day). Increased incidences of skeletal variations considered to be delays in ossification associated with reduced body weight were observed at doses about 56 times the MRHD (animal dose of 12.5 mg / kg per day).
In a rabbit embryo-fetal study, doses 28- to 93-fold the MRHD (animal doses of 30, 100, and 200 mg / kg per day) were administered orally during the period of major organogenesis (gestation days 7 to 29) to encompass the late period of external genitalia development. Histological evaluation of the genital papilla of fetuses revealed evidence of feminization of the male fetus at all doses. A second embryo-fetal study in rabbits at 0.3- to 53-fold the expected clinical exposure (animal doses of 0.05, 0.4, 3.0, and 30 mg / kg per day) also produced evidence of feminization of the genitalia in male fetuses at all doses.
In an oral pre- and post-natal development study in rats, Dutasteride (Avodart) doses of 0.05, 2.5, 12.5, or 30 mg / kg per day were administered. Unequivocal evidence of feminization of the genitalia (i.e., decreased anogenital distance, increased incidence of hypospadias, nipple development) of male offspring occurred at 14- to 90-fold the MRHD (animal doses of 2.5 mg / kg per day or greater). At 0.05-fold the expected clinical exposure (animal dose of 0.05 mg / kg per day), evidence of feminization was limited to a small, but statistically significant, decrease in anogenital distance.
Animal doses of 2.5 to 30 mg / kg per day resulted in prolonged gestation in the parental females and a decrease in time to vaginal patency for female offspring and a decrease in prostate and seminal vesicle weights in male offspring. Effects on newborn startle response were noted at doses greater than or equal to 12.5 mg / kg per day. Increased stillbirths were noted at 30 mg / kg per day.
In an embryo-fetal development study, pregnant rhesus monkeys were exposed intravenously to a dutasteride blood level comparable to the dutasteride concentration found in human semen. Avodart (Dutasteride) was administered on gestation days 20 to 100 at doses of 400, 780, 1,325, or 2,010 ng / day (12 monkeys / group). The development of male external genitalia of monkey offspring was not adversely affected. Reduction of fetal adrenal weights, reduction in fetal prostate weights, and increases in fetal ovarian and testis weights were observed at the highest dose tested in monkeys. Based on the highest measured semen concentration of dutasteride in treated men (14 ng / mL), these doses represent 0.8 to 16 times the potential maximum exposure of a 50-kg human female to 5 mL semen daily from a dutasteride-treated man, assuming 100% absorption. (These calculations are based on blood levels of parent drug which are achieved at 32 to 186 times the daily doses administered to pregnant monkeys on a ng / kg basis). Dutasteride (Avodart) is highly bound to proteins in human semen (greater than 96%), potentially reducing the amount of dutasteride available for vaginal absorption. It is not known whether rabbits or rhesus monkeys produce any of the major human metabolites.
Estimates of exposure multiples comparing animal studies to the MRHD for dutasteride are based on clinical serum concentration at steady state.
Avodart (Dutasteride) is contraindicated for use in women of childbearing potential, including nursing women. It is not known whether dutasteride is excreted in human milk.
Dutasteride (Avodart) is contraindicated for use in pediatric patients. Safety and effectiveness in pediatric patients have not been established.
Of 2,167 male subjects treated with Avodart in 3 clinical studies, 60% were aged 65 years and older and 15% were aged 75 years and older. No overall differences in safety or efficacy were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
No dose adjustment is necessary for Avodart (Dutasteride) in patients with renal impairment.
The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied. Because this drug is extensively metabolized, exposure could be higher in hepatically impaired patients. However, in a clinical study where 60 subjects received 5 mg (10 times the therapeutic dose) daily for 24 weeks, no additional adverse events were observed compared with those observed at the therapeutic dose of 0.5 mg.
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