idarucizumab (Praxbind)
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Indications
- reversal of dabigatran toxicity
* idarucizumab reverses dabigatran across spectrum of renal failure[4]
Dosage
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
More general terms
Additional terms
References
- ↑ 1.0 1.1 1.2 Pollack CV et al Idarucizumab for Dabigatran Reversal N Engl J Med. June 22, 2015 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/26095746 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1502000
Bauer KA Targeted Anti-Anticoagulants. N Engl J Med. June 22, 2015 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/26095632 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMe1506600 - ↑ 2.0 2.1 2.2 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 - ↑ 3.0 3.1 Pollack CV, Jr. Reilly PA, van Ryn J et al Idarucizumab for Dabigatran Reversal - Full Cohort Analysis. N Engl J Med. July 11, 2017 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28693366 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1707278
- ↑ 4.0 4.1 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: https://www.ncbi.nlm.nih.gov/pubmed/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