Difference between revisions of "Andexanet alfa (Andexxa)"
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| − | = | + | ==General information== |
| − | Recombinant inactive FXa, used for specific reversal of DOACs (direct oral anticoagulants). | + | Class/mechanism: Recombinant inactive FXa, used for specific reversal of DOACs (direct oral anticoagulants) [[Rivaroxaban (Xarelto)]] and [[Apixaban (Eliquis)]]. Coagulation factor Xa (recombinant) inactivated-zheo binds and sequesters rivaroxaban and apixaban, negating their factor Xa inhibiting, anticoagulant effect. It also inhibits Tissue Factor Pathway Inhibitor (TFPI); inhibition of TFPI can increase tissue factor-initiated thrombin generation.<ref name="insert">[https://www.andexxa.com/prescribing-information/ Factor Xa, recombinant, inactivated-zhzo (Andexxa) package insert]</ref><ref>[[Media:FactorXarecombinant.pdf | Factor Xa, recombinant, inactivated-zhzo (Andexxa) package insert (locally hosted backup)]]</ref><ref>[https://www.andexxa.com/ Andexxa manufacturer's website]</ref> |
| + | <br>Route: IV | ||
| + | <br>Extravasation: no information | ||
| + | |||
| + | For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> | ||
| + | |||
| + | ==Patient drug information== | ||
| + | *Brief patient counseling information can be found in the [https://www.andexxa.com/prescribing-information/ Factor Xa, recombinant, inactivated-zhzo (Andexxa) package insert]<ref name="insert"></ref> | ||
=Preliminary data= | =Preliminary data= | ||
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=History of changes in FDA indication= | =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." | + | *5/4/2018: FDA approved "for patients treated with [[Rivaroxaban (Xarelto)|rivaroxaban]] and [[Apixaban (Eliquis)|apixaban]], when reversal of anticoagulation is necessary due to fatal or uncontrolled bleeding." |
=Also known as= | =Also known as= | ||
*'''Code name:''' PRT4445 | *'''Code name:''' PRT4445 | ||
*'''Generic name:''' andexanet alfa | *'''Generic name:''' andexanet alfa | ||
| + | |||
| + | ==References== | ||
| + | <references/> | ||
[[Category:Drug index]] | [[Category:Drug index]] | ||
Revision as of 12:13, 10 May 2018
General information
Class/mechanism: Recombinant inactive FXa, used for specific reversal of DOACs (direct oral anticoagulants) Rivaroxaban (Xarelto) and Apixaban (Eliquis). Coagulation factor Xa (recombinant) inactivated-zheo binds and sequesters rivaroxaban and apixaban, negating their factor Xa inhibiting, anticoagulant effect. It also inhibits Tissue Factor Pathway Inhibitor (TFPI); inhibition of TFPI can increase tissue factor-initiated thrombin generation.[1][2][3]
Route: IV
Extravasation: no information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Patient drug information
- Brief patient counseling information can be found in the Factor Xa, recombinant, inactivated-zhzo (Andexxa) package insert[1]
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