Idarucizumab (Praxbind)

General information

Class/mechanism: Monoclonal antibody fragment (Fab) that binds to Dabigatran (Pradaxa) and its metabolites with higher affinity than dabigatran binds to thrombin, which neutralizes the anticoagulant effect of dabigatran.
Route: IV
Extravasation: no information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is used

• Bleeding with anticoagulation

Patient drug information

• Idarucizumab (Praxbind) package insert

History of changes in FDA indication

• 2015-10-16: FDA approved "in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed:
  • For emergency surgery/urgent procedures
  • In life-threatening or uncontrolled bleeding"

Also known as

• Code name: BI 655075
• Brand name: Praxbind