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ALFUSIN-D (ALFUZOSIN/DUTASTERIDE) TABLETS: USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category X

Alfusin-D tablets are contraindicated for use in women of childbearing potential and during pregnancy. Dutasteride is a 5 alpha-reductase inhibitor that prevents conversion of testosterone to DHT, a hormone necessary for the normal development of male genitalia. In animal reproduction and developmental toxicity studies, dutasteride inhibited normal development of external genitalia in male foetuses. Therefore, dutasteride may cause foetal harm when administered to a pregnant woman. If dutasteride is used during pregnancy or if the patient becomes pregnant while taking dutasteride, the patient should be apprised of the potential hazard to the foetus.

Abnormalities in the genitalia of male foetuses 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 foetal exposure, women who are pregnant or may become pregnant should not handle dutasteride. If contact is made with broken Alfusin-D tablet, the contact area should be washed immediately with soap and water. Dutasteride is secreted into male 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 0.175 ng/mL. This concentration is more than 100 times less than concentrations producing abnormalities of male genitalia in animal studies. Dutasteride is highly protein-bound in human semen (>96%), which may reduce the amount of dutasteride available for vaginal absorption.

Lactation

Alfusin-D is not indicated for use in nursing mothers. It is not known whether dutasteride is excreted in human milk.

Paediatric Use

Alfusin-D is not indicated for use in the paediatric population.

Efficacy of alfuzosin hydrochloride was not demonstrated in a randomized, double-blind, placebo-controlled, efficacy and safety trial conducted in 172 patients ages 2 to 16 years with elevated detrusor leak point pressure (LPP >= 40 cm H2O) of neurologic origin treated with alfuzosin hydrochloride using pediatric formulations. The trial included a 12-week efficacy phase followed by a 40-week safety extension period. No statistically significant difference in the proportion of patients achieving a detrusor leak point pressure of < 40 cm H20 was observed between the alfuzosin and placebo groups.

During the placebo-controlled trial, the adverse reactions reported in #8805;2% of patients treated with alfuzosin and at a higher incidence than in the placebo group were: pyrexia, headache, respiratory tract infection, cough, epistaxis and diarrhea. The adverse reactions reported for the whole 12-month trial period, which included the open-label extension, were similar in type and frequency to the reactions observed during the 12-week period. Alfuzosin hydrochloride was not studied in patients below the age of 2. Safety and effectiveness of dutasteride in the paediatric population have not been established.

Geriatric Use

Of the total number of subjects in clinical studies of alfuzosin hydrochloride, 48% were 65 years of age and over, whereas 11% were 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but the greater sensitivity of some older individuals cannot be ruled out.

Of 2167 male subjects treated with dutasteride in three clinical trials, 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.

Renal Impairment

Caution should be exercised when alfuzosin hydrochloride is administered in patients with severe renal impairment (creatinine clearance < 30 mL / min). Systemic exposure was increased by approximately 50% in pharmacokinetic studies of patients with mild, moderate, and severe renal impairment. In phase 3 studies, the safety profile of patients with mild (n=172) or moderate (n=56) renal impairment was similar to the patients with normal renal function in those studies. Safety data are available in only a limited number of patients (n=6) with creatinine clearance below 30 mL / min.

The effect of renal impairment on dutasteride pharmacokinetics has not been studied. However, less than 0.1% of a steady-state 0.5-mg dose of dutasteride is recovered in human urine, so no adjustment in dosage is anticipated for patients with renal impairment.

Hepatic Impairment

Alfuzosin HCl is contraindicated for use in patients with moderate or severe hepatic impairment. Although the pharmacokinetics of alfuzosin hydrochloride has not been studied in patients with mild hepatic impairment, caution should be exercised when alfuzosin hydrochloride is administered to such patients.

The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied. Because dutasteride 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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