Update on Therapeutic Protein–Drug Interaction: Information in Labeling

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.