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ACOMPLIA (RIMONABANT): SPECIAL POPULATIONS

Race:

In single- and repeat-dose studies, the Cmax and AUC of Acomplia (Rimonabant) were similar in healthy Japanese and Caucasian subjects, whereas elimination half-life was shorter in Japanese subjects (3-4 days) compared to Caucasian subjects (about 9 days). The difference in half-life was due to differences in peripheral volume of distribution as a consequence of lower weight in Japanese subjects.

Black patients may have up to a 31% lower Cmax and a 43% lower AUC than patients of other races.

Gender:

The pharmacokinetics of rimonabant are similar in female and male patients.

Elderly:

Elderly patients have slightly higher exposure than young patients. Based on a population pharmacokinetic analysis (age range 18 - 81 years) a 75 year old patient is estimated to have a 21% higher Cmax and a 27% higher AUC than a 40 year old patient.

Patients with hepatic insufficiency:

Mild hepatic impairment does not alter rimonabant exposure. Data are insufficient to draw conclusions regarding pharmacokinetics in moderate hepatic impairment. Patients with severe hepatic impairment were not evaluated.

Patients with renal impairment:

The effect of renal function on the pharmacokinetics of Acomplia (Rimonabant) has not been studied specifically.

Based on data from population pharmacokinetic studies, mild renal impairment do not seem to affect the pharmacokinetics of rimonabant. Limited data suggest an increased exposure in patients with moderate renal impairment (40% increase in AUC). There are no data in severe renal impairment.

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