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idarucizumab (Praxbind)
Indications:
- reversal of dabigatran toxicity
* idarucizumab reverses dabigatran across spectrum of renal failure [4]
Dosage:
- 5 g IV, given as two boluses < 15 minutes apart
Pharmacokinetics:
- maximum reversal of dabigatran's anticoagulant effect is 100% within 4 hours of idarucizumab infusion
- reversal persists for 24 hours in most patients [3]
Adverse effects:
- headache (in healthy volunteers)
- hypokalemia, confusion, constipation, fever, pneumonia [2]
Mechanism of action:
- humanized monoclonal antibody fragment that binds dabigatran*
* industry-funded, phase II trial [1]
* FDA-approved [2] lack of a control group to assess clinical benefits [1]
Notes:
- US wholesale cost: $3500 (not clear how many dabigtran toxicity reversals this would facilitate)
Interactions
drug adverse effects of pharmaceutical monoclonal antibodies
Related
dabigatran (Pradaxa)
General
antidote
pharmaceutical monoclonal antibody
References
- Pollack CV et al
Idarucizumab for Dabigatran Reversal
N Engl J Med. June 22, 2015
PMID: 26095746
http://www.nejm.org/doi/full/10.1056/NEJMoa1502000
- Bauer KA
Targeted Anti-Anticoagulants.
N Engl J Med. June 22, 2015
PMID: 26095632
http://www.nejm.org/doi/full/10.1056/NEJMe1506600
- FDA News Release. October 16, 2015
FDA approves Praxbind, the first reversal agent for the
anticoagulant Pradaxa
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm467300.htm
- Boehringer Ingelheim Press Release. Oct 20, 2015
FDA Approves Praxbind (idarucizumab), Specific Reversal Agent
for Pradaxa (dabigatran etexilate mesylate).
http://us.boehringer-ingelheim.com/news_events/press_releases/press_release_archive/2015/10-16-2015-fda-approves-praxbind-idarucizumab-specific-reversal-agent-pradaxa-dabigatran-etexilate-mesylate.html
- Elia J, Fairchild DG, Hefner E
Dabigatran-Reversal Agent Price Set
Physician's First Watch, Oct 20, 2015
David G. Fairchild, MD, MPH, Editor-in-Chief
Massachusetts Medical Society
http://www.jwatch.org
- Pollack CV, Jr. Reilly PA, van Ryn J et al
Idarucizumab for Dabigatran Reversal - Full Cohort Analysis.
N Engl J Med. July 11, 2017
PMID: 28693366
http://www.nejm.org/doi/full/10.1056/NEJMoa1707278
- Eikelboom JW, van Ryn J, Reilly P et al.
Dabigatran reversal with idarucizumab in patients with renal
impairment.
J Am Coll Cardiol 2019 Oct 8; 74:1760.
PMID: 31582135 Free Article
https://www.sciencedirect.com/science/article/pii/S0735109719362667
- BIND. HIGHLIGHTS OF PRESCRIBING INFORMATION.
http://us.boehringer-ingelheim.com/content/dam/internet/opu/us_EN/documents/Media_Press_Releases/2015/Praxbind.pdf