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Andexanet alfa information


Andexanet alfa
Clinical data
Trade namesAndexxa, Ondexxya, others
Other namesCoagulation factor Xa (recombinant), inactivated-zhzo, PRT06445, r-Antidote, PRT4445
AHFS/Drugs.comMonograph
License data
  • US DailyMed: Andexanet_alfa
Pregnancy
category
  • AU: B2[1]
Routes of
administration
Intravenous injection
ATC code
  • V03AB38 (WHO)
Legal status
Legal status
  • AU: S4 (Prescription only)[1][3][4]
  • CA: ℞-only / Schedule D[5][6][7]
  • UK: POM (Prescription only)
  • US: WARNING[2]Rx-only[8]
  • EU: Rx-only
Pharmacokinetic data
Elimination half-life5 h to 7 h
Identifiers
IUPAC name
  • Andexanet alfa
CAS Number
  • 1262449-58-0
IUPHAR/BPS
  • 7576
DrugBank
  • DB14562
ChemSpider
  • none
UNII
  • BI009E452R
KEGG
  • D11029
ChEMBL
  • ChEMBL3301583

Andexanet alfa, sold under the brand name Andexxa among others, is an antidote for the medications rivaroxaban and apixaban, when reversal of anticoagulation is needed due to uncontrolled bleeding.[8] It has not been found to be useful for other factor Xa inhibitors.[9] It is given by injection into a vein.[9]

Common side effects include pneumonia and urinary tract infections.[9] Severe side effects may include blood clots, heart attacks, strokes, or cardiac arrest.[9] It works by binding to rivaroxaban and apixaban.[9]

It was approved for medical use in the United States in May 2018.[8] It was developed by Portola Pharmaceuticals.[10]

  1. ^ a b "Andexxa APMDS". Therapeutic Goods Administration (TGA). 12 July 2023. Retrieved 10 September 2023.
  2. ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
  3. ^ "Andexxa (AstraZeneca Pty Ltd)". Therapeutic Goods Administration (TGA). 28 July 2023. Archived from the original on 11 September 2023. Retrieved 10 September 2023.
  4. ^ "AusPAR: Andexxa". Therapeutic Goods Administration (TGA). 19 December 2023. Retrieved 31 March 2024.
  5. ^ "Details for: Ondexxya". Health Canada. 16 June 2023. Archived from the original on 3 March 2024. Retrieved 3 March 2024.
  6. ^ "Summary Basis of Decision (SBD) for Ondexxya". Health Canada. Retrieved 11 December 2023.
  7. ^ "Notice: Multiple additions to the Prescription Drug List (PDL) [2023-08-30]". Health Canada. 26 October 2023. Archived from the original on 3 January 2024. Retrieved 3 January 2024.
  8. ^ a b c "Andexxa- andexanet alfa injection, powder, lyophilized, for solution". DailyMed. 21 September 2020. Archived from the original on 18 November 2020. Retrieved 12 November 2020.
  9. ^ a b c d e "Andexxa Monograph for Professionals". Drugs.com. Archived from the original on 19 December 2018. Retrieved 19 December 2018.
  10. ^ Dolgin E (March 2013). "Antidotes edge closer to reversing effects of new blood thinners". Nature Medicine. 19 (3): 251. doi:10.1038/nm0313-251. PMID 23467222. S2CID 13340319.

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