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Idarucizumab

Summary

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

Idarucizumab
Monoclonal antibody
TypeFab fragment
SourceHumanized (from mouse)
TargetDabigatran
Clinical data
Trade namesPraxbind
Other namesBI-655075
AHFS/Drugs.comMonograph
License data
Pregnancy
category
  • AU: B2
Routes of
administration		Intravenous
ATC code
Legal status
Legal status
Identifiers
CAS Number
  • 1362509-93-0
IUPHAR/BPS
  • 8298
DrugBank
  • DB09264
ChemSpider
  • none
UNII
  • 97RWB5S1U6
KEGG
  • D10741 checkY
Chemical and physical data
FormulaC2131H3299N555O671S11
Molar mass47782.71 g·mol−1

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 edit

Names edit

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 edit

  1. ^ "Prescription medicines: registration of new chemical entities in Australia, 2016". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
  2. ^ "Health Canada New Drug Authorizations: 2016 Highlights". Health Canada. 14 March 2017. Retrieved 7 April 2024.
  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. ^ a b c "Praxbind- idarucizumab injection". DailyMed. 1 December 2019. Retrieved 19 August 2020.
  5. ^ a b "Praxbind EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 16 October 2020.
  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. ^ "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. ^ 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. ^ 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. ^ Statement On A Nonproprietary Name Adopted By The USAN Council - Idarucizumab Archived 2015-06-27 at the Wayback Machine, American Medical Association.