Coagulation factor Xa (recombinant), inactivated-zhzo, PRT06445, r-Antidote, PRT4445
AHFS/Drugs.com
Monograph
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-life
5 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]
^ ab"Andexxa APMDS". Therapeutic Goods Administration (TGA). 12 July 2023. Retrieved 10 September 2023.
^"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.
^"Andexxa (AstraZeneca Pty Ltd)". Therapeutic Goods Administration (TGA). 28 July 2023. Archived from the original on 11 September 2023. Retrieved 10 September 2023.
^"AusPAR: Andexxa". Therapeutic Goods Administration (TGA). 19 December 2023. Retrieved 31 March 2024.
^"Details for: Ondexxya". Health Canada. 16 June 2023. Archived from the original on 3 March 2024. Retrieved 3 March 2024.
^"Summary Basis of Decision (SBD) for Ondexxya". Health Canada. Retrieved 11 December 2023.
^"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.
^ abc"Andexxa- andexanet alfa injection, powder, lyophilized, for solution". DailyMed. 21 September 2020. Archived from the original on 18 November 2020. Retrieved 12 November 2020.
^ abcde"Andexxa Monograph for Professionals". Drugs.com. Archived from the original on 19 December 2018. Retrieved 19 December 2018.
^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.
Andexanetalfa, sold under the brand name Andexxa among others, is an antidote for the medications rivaroxaban and apixaban, when reversal of anticoagulation...
reuptake inhibitors, and nonsteroidal anti-inflammatory drugs (NSAIDs). Andexanetalfa is a US Food and Drug Administration (FDA) approved antidote for apixaban...
DOACs are not as widely studied, idarucizumab (for dabigatran) and andexanetalfa (for factor Xa inhibitor) have been used in clinical settings with varying...
asfotase alfa (Strensiq), used to treat hypophosphatasia; sebelipase alfa (Kanuma), used to treat lysosomal acid lipase deficiency, and andexanetalfa (Andexxa)...
authorisation for Andexanetalfa (in EU: Ondexxya). In April 2019 the European Commission granted the authorisation (approved) Andexanet for the 28 countries...
dabigatran (idarucizumab), and for apixaban, and rivaroxaban (andexanetalfa). Andexanetalfa is suggested for edoxaban, but use of it is considered off...
Hemodialysis does not significantly contribute to edoxaban clearance. Andexanetalfa has been studied as an antidote for edoxaban overdose, but has only...
antiplatelet medication. The specific reversal agents idarucizumab and andexanetalfa may be used to stop continued intracerebral hemorrhage in people taking...