| Monoclonal antibody | |
|---|---|
| Type | Fab fragment |
| Source | Humanized (from mouse) |
| Target | Dabigatran |
| Clinical data | |
| Trade names | Praxbind |
| Other names | BI-655075 |
| AHFS/Drugs.com | Monograph |
| License data |
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| Pregnancy category |
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| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| IUPHAR/BPS | |
| DrugBank | |
| ChemSpider |
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| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C2131H3299N555O671S11 |
| Molar mass | 47782.71 g·mol−1 |
Idarucizumab, sold under the brand name Praxbind, is a monoclonal antibody used as a reversal agent for dabigatran.[4]
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]
- ^ "Prescription medicines: registration of new chemical entities in Australia, 2016". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
- ^ "Health Canada New Drug Authorizations: 2016 Highlights". Health Canada. 14 March 2017. Retrieved 7 April 2024.
- ^ "Praxbind 2.5 g/50 mL solution for injection/infusion - Summary of Product Characteristics (SmPC)". (emc). 1 July 2022. Retrieved 1 July 2022.
- ^ a b c "Praxbind- idarucizumab injection". DailyMed. U.S. National Library of Medicine. 1 December 2019. Retrieved 19 August 2020.
- ^ a b "Praxbind EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 16 October 2020.
- ^ 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): 511–520. doi:10.1056/NEJMoa1502000. PMID 26095746.
- ^ "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.