Idarucizumab

Idarucizumab

Idarucizumab

Medication

Idarucizumab, sold under the brand name Praxbind, is a monoclonal antibody used as a reversal agent for dabigatran.[4]

Quick Facts Monoclonal antibody, Type ...

Idarucizumab was developed by Boehringer Ingelheim. One study sponsored by the manufacturer found that idarucizumab effectively reversed anticoagulation caused by dabigatran within minutes.[6]

It was approved for medical use in the United States and in the European Union in 2015.[7][4][5]

Society and culture

Names

Idarucizumab is the International nonproprietary name (INN).[8] The description was updated in 2016.[9] Idarucizumab is the United States Adopted Name (USAN).[10]

References

  1. [1]
    "Prescription medicines: registration of new chemical entities in Australia, 2016". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
  2. [2]
    "Health Canada New Drug Authorizations: 2016 Highlights". Health Canada. 14 March 2017. Retrieved 7 April 2024.
  3. [3]
    "Praxbind 2.5 g/50 mL solution for injection/infusion - Summary of Product Characteristics (SmPC)". (emc). 1 July 2022. Retrieved 1 July 2022.
  4. [4]
    "Praxbind- idarucizumab injection". DailyMed. 1 December 2019. Retrieved 19 August 2020.
  5. [5]
    "Praxbind EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 16 October 2020.
  6. [6]
    Pollack CV, Reilly PA, Eikelboom J, Glund S, Verhamme P, Bernstein RA, et al. (August 2015). "Idarucizumab for Dabigatran Reversal". The New England Journal of Medicine. 373 (6): 511–20. doi:10.1056/NEJMoa1502000. PMID 26095746.
  7. [7]
    "FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa". U.S. Food and Drug Administration (FDA) (Press release). Archived from the original on 2015-10-17. Retrieved 2015-10-17.
  8. [8]
    World Health Organization (2014). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 71". WHO Drug Information. 28 (1): 90–91. hdl:10665/331151.
  9. [9]
    World Health Organization (2016). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 76". WHO Drug Information. 30 (3): 544. hdl:10665/331020.
  10. [10]
    Statement On A Nonproprietary Name Adopted By The USAN Council - Idarucizumab Archived 2015-06-27 at the Wayback Machine, American Medical Association.
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