Update on Therapeutic Protein-Drug Interaction: Information in Labeling

Xing Jing; Ping Ji; Sarah J Schrieber; Elimika P Fletcher; Chandrahas Sahajwalla

doi:10.1007/s40262-019-00810-z

Update on Therapeutic Protein-Drug Interaction: Information in Labeling

Clin Pharmacokinet. 2020 Jan;59(1):25-36. doi: 10.1007/s40262-019-00810-z.

Authors

Xing Jing¹, Ping Ji¹, Sarah J Schrieber², Elimika P Fletcher², Chandrahas Sahajwalla³

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.
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.
³ 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. chandrahas.sahajwalla@fda.hhs.gov.

PMID: 31583608
DOI: 10.1007/s40262-019-00810-z

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.

Publication types

Review

MeSH terms

Animals
Clinical Trials as Topic
Cross-Over Studies
Cytokines / pharmacokinetics*
Cytokines / therapeutic use
Drug Interactions / physiology*
Drug Labeling / statistics & numerical data*
Humans
Models, Animal
Peptides / pharmacokinetics*
Peptides / therapeutic use
Pharmaceutical Preparations / standards
United States / epidemiology
United States Food and Drug Administration / organization & administration
United States Food and Drug Administration / standards

Substances

Cytokines
Peptides
Pharmaceutical Preparations