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Pharmacokinetics and safety of revefenacin in individuals with impaired renal or hepatic function

International Journal of COPD Oct 16, 2019

Borin MT, et al. - Researchers assessed pharmacokinetics and safety results of revefenacin (a long-acting muscarinic antagonist for nebulization) in individuals with severe renal impairment and moderate hepatic impairment by analyzing outcomes from two multicenter, open-label, single-dose trials of revefenacin in these patient populations. In the renal impairment trial, the participants were people with normal renal function and severe renal impairment, and the hepatic impairment trial was performed on people with normal hepatic function and moderate hepatic impairment. A single 175-μg dose of revefenacin via nebulization was administered to individuals. Findings revealed a modest rise in systemic exposure to revefenacin in participants with severe renal impairment but it was similar between those with moderate hepatic impairment and normal hepatic function. The clinical consequence of increased plasma exposure to THRX-195518 (the major metabolite of revefenacin) in participants with severe renal or moderate hepatic impairment was unlikely owing to its low antimuscarinic potency, low systemic levels following inhaled revefenacin administration, and favorable safety profile.
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