Pharmacokinetics of idarucizumab and its target dabigatran in patients requiring urgent reversal of the anticoagulant effect of dabigatran.

ABSTRACT:

Background

Idarucizumab is a monoclonal antibody fragment that reverses dabigatran anticoagulation. Pharmacokinetics (PK) of idarucizumab have been described in healthy, elderly, or renally impaired (RI) volunteers, but PK data in patients are lacking.

Objectives

This analysis describes the PK of idarucizumab and its target dabigatran in bleeding/surgical patients.

Patients and methods

Results from the Reversal Effects of Idarucizumab on Active Dabigatran study, a prospective, multicenter, single-arm study demonstrated the reversal of dabigatran anticoagulation by idarucizumab in patients with uncontrollable bleeding (group A) or who needed urgent surgery (group B). Idarucizumab and unbound dabigatran concentrations, immunogenicity, and pharmacodynamics were assessed.

SUBMITTER: Glund S 

PROVIDER: S-EPMC6852568 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature