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.
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.
Patient drug information
History of changes in FDA indication
- 10/16/2015: 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"
- Idarucizumab (Praxbind) package insert
- Idarucizumab (Praxbind) package insert (locally hosted backup)
- Praxbind manufacturer's website
- Pollack CV Jr, Reilly PA, Eikelboom J, Glund S, Verhamme P, Bernstein RA, Dubiel R, Huisman MV, Hylek EM, Kamphuisen PW, Kreuzer J, Levy JH, Sellke FW, Stangier J, Steiner T, Wang B, Kam CW, Weitz JI. Idarucizumab for dabigatran reversal. N Engl J Med. 2015 Aug 6;373(6):511-520. Epub 2015 Jun 22. link to original article PubMed
- Pollack CV Jr, Reilly PA, van Ryn J, Eikelboom JW, Glund S, Bernstein RA, Dubiel R, Huisman MV, Hylek EM, Kam CW, Kamphuisen PW, Kreuzer J, Levy JH, Royle G, Sellke FW, Stangier J, Steiner T, Verhamme P, Wang B, Young L, Weitz JI. Idarucizumab for dabigatran reversal - full cohort analysis. N Engl J Med. 2017 Aug 3;377(5):431-441. Epub 2017 Jul 11. link to original article PubMed