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Update on Therapeutic Protein–Drug Interaction: Information in Labeling

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Abstract

This review evaluated the significance of therapeutic protein (TP)–drug interactions and the current practices for assessing the interaction potential. We reviewed US FDA labels of approved TPs with drug–drug interaction (DDI) assessment. TP–drug interactions have been evaluated from in vitro studies, animal studies, and/or clinical settings. Of the 150 FDA-approved TPs as of May 2019, 49 TP labels contained pharmacokinetic (PK)-related DDI information derived from at least one study method. Our review found that more than half of the clinical PK DDI evaluations showed no interaction, and no dose adjustment has been recommended for any of the rest TPs. The results and trends observed in this review may further enhance and inform risk-based approaches to evaluating the potential for TP–drug interactions.

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Authors and Affiliations

  1. Division of Clinical Pharmacology II, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA

    Xing Jing, Ping Ji & Chandrahas Sahajwalla

  2. Immediate Office, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA

    Sarah J. Schrieber & Elimika P. Fletcher

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  1. Xing Jing
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Correspondence to Chandrahas Sahajwalla.

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Xing Jing, Ping Ji, Sarah J. Schrieber, Elimika P. Fletcher, and Chandrahas Sahajwalla declare that they have no potential conflicts of interest that might be relevant to the contents of this manuscript.

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Jing, X., Ji, P., Schrieber, S.J. et al. Update on Therapeutic Protein–Drug Interaction: Information in Labeling. Clin Pharmacokinet 59, 25–36 (2020). https://doi.org/10.1007/s40262-019-00810-z

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