Difference between revisions of "Andexanet alfa (Andexxa)"
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m (Jwarner moved page Andexanet alfa (PRT4445) to Factor Xa, recombinant, inactivated-zhzo (Andexxa): FDA approval) |
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=Preliminary data= | =Preliminary data= | ||
| − | # Connolly SJ, Milling TJ Jr, Eikelboom JW, Gibson CM, Curnutte JT, Gold A, Bronson MD, Lu G, Conley PB, Verhamme P, Schmidt J, Middeldorp S, Cohen AT, Beyer-Westendorf J, Albaladejo P, Lopez-Sendon J, Goodman S, Leeds J, Wiens BL, Siegal DM, Zotova E, Meeks B, Nakamya J, Lim WT, Crowther M; ANNEXA-4 Investigators. Andexanet | + | # '''ANNEXA-A/ANNEXA-R:''' Siegal DM, Curnutte JT, Connolly SJ, Lu G, Conley PB, Wiens BL, Mathur VS, Castillo J, Bronson MD, Leeds JM, Mar FA, Gold A, Crowther MA. Andexanet alfa for the reversal of factor Xa inhibitor activity. N Engl J Med. 2015 Dec 17;373(25):2413-24. Epub 2015 Nov 11. [https://www.nejm.org/doi/10.1056/NEJMoa1510991 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/26559317 PubMed] |
| + | # '''ANNEXA-4:''' Connolly SJ, Milling TJ Jr, Eikelboom JW, Gibson CM, Curnutte JT, Gold A, Bronson MD, Lu G, Conley PB, Verhamme P, Schmidt J, Middeldorp S, Cohen AT, Beyer-Westendorf J, Albaladejo P, Lopez-Sendon J, Goodman S, Leeds J, Wiens BL, Siegal DM, Zotova E, Meeks B, Nakamya J, Lim WT, Crowther M; ANNEXA-4 Investigators. Andexanet alfa for acute major bleeding associated with factor Xa inhibitors. N Engl J Med. 2016 Sep 22;375(12):1131-41. Epub 2016 Aug 30. [http://www.nejm.org/doi/full/10.1056/NEJMoa1607887 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5568772/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/27573206 PubMed] | ||
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| + | =History of changes in FDA indication= | ||
| + | *5/4/2018: FDA approved "for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is necessary due to fatal or uncontrolled bleeding." | ||
| + | |||
| + | =Also known as= | ||
| + | *'''Code name:''' PRT4445 | ||
| + | *'''Generic name:''' andexanet alfa | ||
[[Category:Drug index]] | [[Category:Drug index]] | ||
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[[Category:Hematology medications]] | [[Category:Hematology medications]] | ||
[[Category:Hemostasis medications]] | [[Category:Hemostasis medications]] | ||
| − | [[Category: | + | [[Category:Drugs FDA approved in 2018]] |
Revision as of 17:56, 4 May 2018
Mechanism of action
Recombinant inactive FXa, used for specific reversal of DOACs (direct oral anticoagulants).
Preliminary data
- ANNEXA-A/ANNEXA-R: Siegal DM, Curnutte JT, Connolly SJ, Lu G, Conley PB, Wiens BL, Mathur VS, Castillo J, Bronson MD, Leeds JM, Mar FA, Gold A, Crowther MA. Andexanet alfa for the reversal of factor Xa inhibitor activity. N Engl J Med. 2015 Dec 17;373(25):2413-24. Epub 2015 Nov 11. link to original article PubMed
- ANNEXA-4: Connolly SJ, Milling TJ Jr, Eikelboom JW, Gibson CM, Curnutte JT, Gold A, Bronson MD, Lu G, Conley PB, Verhamme P, Schmidt J, Middeldorp S, Cohen AT, Beyer-Westendorf J, Albaladejo P, Lopez-Sendon J, Goodman S, Leeds J, Wiens BL, Siegal DM, Zotova E, Meeks B, Nakamya J, Lim WT, Crowther M; ANNEXA-4 Investigators. Andexanet alfa for acute major bleeding associated with factor Xa inhibitors. N Engl J Med. 2016 Sep 22;375(12):1131-41. Epub 2016 Aug 30. link to original article link to PMC article PubMed
History of changes in FDA indication
- 5/4/2018: FDA approved "for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is necessary due to fatal or uncontrolled bleeding."
Also known as
- Code name: PRT4445
- Generic name: andexanet alfa