Liver Injury with Nintedanib: A Pharmacovigilance-Pharmacokinetic Appraisal.

ABSTRACT: Drug-induced liver injury (DILI) with nintedanib has emerged as an adverse event of special interest in premarketing clinical trials. We characterized DILI with nintedanib in the real world and explored the underlying pharmacological basis. First, we assessed serious hepatic events reported to the Food and Drug Administration's Adverse Event Reporting System by combining the disproportionality approach [reporting odds ratio (ROR) with 95% confidence interval (CI)] with individual case assessment. Demographic and clinical features were inspected (seriousness, onset, discontinuation, dechallenge/rechallenge, concomitant drugs) to implement an ad hoc causality assessment scoring system. Second, we appraised physiochemical and pharmacokinetic parameters possibly predictive of DIL

SUBMITTER: Raschi E 

PROVIDER: S-EPMC9146184 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature