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
IUPHAR/BPS
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC2131H3299N555O671S11
Molar mass47782.71 g·mol−1

Idarucizumab, sold under the brand name Praxbind, is a monoclonal antibody used as a reversal agent for dabigatran.[3]

Idarucizumab was developed by Boehringer Ingelheim. One study sponsored by the manufacturer found that idarucizumab effectively reversed anticoagulation caused by dabigatran within minutes.[5]

It was approved for medical use in the United States and in the European Union in 2015.[6][3][4]

Society and culture

Names

Idarucizumab is the International nonproprietary name (INN).[7] The description was updated in 2016.[8] Idarucizumab is the United States Adopted Name (USAN).[9]

See also

References

  1. ^ "Prescription medicines: registration of new chemical entities in Australia, 2016". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
  2. ^ "Praxbind 2.5 g/50 mL solution for injection/infusion - Summary of Product Characteristics (SmPC)". (emc). 1 July 2022. Retrieved 1 July 2022.
  3. ^ a b c "Praxbind- idarucizumab injection". DailyMed. 1 December 2019. Retrieved 19 August 2020.
  4. ^ a b "Praxbind EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 16 October 2020.
  5. ^ 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.
  6. ^ "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.
  7. ^ 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.
  8. ^ World Health Organization (2016). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 76". WHO Drug Information. 30 (3): 544. hdl:10665/331020.
  9. ^ Statement On A Nonproprietary Name Adopted By The USAN Council - Idarucizumab Archived 2015-06-27 at the Wayback Machine, American Medical Association.

External links

Antidotes (V03AB)
Monoclonals for bone, musculoskeletal, circulatory, and neurologic systems
More
Categories