Andexanet alfa

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Andexanet alfa
Clinical data
Trade namesAndexxa, Ondexxya, others
Other namesCoagulation factor Xa (recombinant), inactivated-zhzo, PRT06445, r-Antidote, PRT4445
AHFS/Drugs.comMonograph
License data
Pregnancy
category
Intravenous injection
ATC code
Legal status
Legal status
Pharmacokinetic data
Elimination half-life5 h to 7 h
Identifiers
  • Andexanet alfa
CAS Number
IUPHAR/BPS
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL

Andexanet alfa, sold under the brand name Andexxa among others, is an

injection into a vein.[9]

Common side effects include

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]

Medical uses

Andexanet alfa is used to stop life-threatening or uncontrollable bleeding in people who are taking rivaroxaban or apixaban.[8]

There are no randomised clinical trials as of 2019. Studies in healthy volunteers show that the molecule binds

factor Xa inhibitors and counters their anti-Xa-activity.[11] The only published clinical trial is a prospective, open label, single group study.[12] This study reports results on 352 people and demonstrates a reduction of anti-Xa-activity while also showing an excellent or good hemostatic efficacy in 82%. While people who were expected to die in 30 days were excluded from the study, 14% of participants died. There was no relationship between hemostatic efficacy and reduced anti-Xa-activity.[13] The FDA has demanded a randomised clinical trial: the first results are not expected before 2023.[14]

Adverse effects

Common side effects include pneumonia and urinary tract infections.

blood clots or cardiac arrest.[9]

Andexanet alfa has a

ischemic events, cardiac arrest, and sudden deaths.[8]

Pharmacology

Mechanism of action

Andexanet alfa is a

factor IIa inhibitor dabigatran.[18] Its activity is measured using the anti-Xa test, which is utilized to determine the amount of available factor Xa for coagulation[19]

History

It was approved in the United States in 2018 based on data from two phase III studies on reversing the anticoagulant activity of FXa inhibitors rivaroxaban and apixaban in healthy volunteers.[11] As a condition of its accelerated approval there is a study being conducted comparing it to other currently used reversal agents ("usual care").[12][20]

Society and culture

Economics

Initial pricing (AWP) is $58,000 per reversal (800 mg bolus + 960 mg infusion, $3,300 per 100 mg vial) which is higher than reversal agents for other DOAC agents (idarucizumab for use in dabigatran reversal is $4,200 per reversal).[21]

References

  1. ^ a b "Andexxa APMDS". Therapeutic Goods Administration (TGA). 12 July 2023. Retrieved 10 September 2023.
  2. 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 d e "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 f g "Andexxa Monograph for Professionals". Drugs.com. Archived from the original on 19 December 2018. Retrieved 19 December 2018.
  10. ^
    S2CID 13340319
    .
  11. ^
    PMID 26559317
    .
  12. ^
    PMID 30730782
    .
  13. ^ Morgenstern J (11 February 2019). "Andexanet Alfa: More garbage science in the New England Journal of Medicine". First10EM blog. Archived from the original on 1 March 2021. Retrieved 5 February 2020.
  14. ^ Clinical trial number NCT03661528 for "A Randomized Clinical Trial of Andexanet Alfa in Acute Intracranial Hemorrhage in Patients Receiving an Oral Factor Xa Inhibitor " at ClinicalTrials.gov
  15. ISSN 0006-4971
    .
  16. PMID 28979172
    .
  17. S2CID 11235887
    .
  18. ^ Spreitzer H (23 December 2013). "Neue Wirkstoffe – Andexanet Alfa". Österreichische Apothekerzeitung (in German) (26/2013): 40.
  19. S2CID 195788543
    .
  20. ^ Clinical trial number NCT03661528 for "Trial of Andexanet in ICH Patients Receiving an Oral FXa Inhibitor" at ClinicalTrials.gov
  21. ^ "Lexi Comp Drug Information Online". 24 May 2018. Archived from the original on 5 October 2020. Retrieved 24 May 2018.

Further reading

External links
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