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Clin Pharmacol Ther 2020 Jan 3 [Epub ahead of print]

Does hepatic impairment affect the exposure of monoclonal antibodies?

Sun Q, Seo S, Zvada S, Liu C, Reynolds K


Limited information is available regarding the effect of hepatic impairment (HI) on the pharmacokinetics of monoclonal antibodies (mAbs). The results of an earlier report based on therapeutic proteins (TPs), including mAbs, approved through the end of 2012 were inconclusive due to limited HI data available at that time. New HI data for mAbs or antibody-drug conjugates (ADCs; with a focus on the mAb component) available between 2013 and 2018 were evaluated. The investigation indicates there is almost no data for severe HI, limited data for moderate HI, and abundant data for mild HI. A significant exposure decrease was found for several mAbs or ADCs and a trend for decreasing AUC was observed for other mAbs. Multiple potential mechanisms may contribute to the exposure decrease. Dose may need to be adjusted for patients with HI, after taking into account the exposure-response relationships for both efficacy and safety.

Category: Journal Article
PubMed ID: #31899819 DOI: 10.1002/cpt.1765
Includes FDA Authors from Scientific Area(s): Drugs
Entry Created: 2020-01-06 Entry Last Modified: 2020-02-09