Difference between revisions of "Andexanet alfa (Andexxa)"
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Warner-admin (talk | contribs) m (Text replacement - "please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [https://online.lexi.com/lco/action/login UpToDate Lexidrug], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information" to "please refer to your preferred pharmacopeias or the prescribing information") |
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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>[[:File: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 | ||
| − | + | *[https://www.guidetopharmacology.org/GRAC/LigandDisplayForward?tab=clinical&ligandId=7576 IUPHAR/BPS] | |
| − | |||
| − | |||
| − | + | 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 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> | ||
| + | |||
| + | ==Diseases for which it is used== | ||
| + | *[[Bleeding with anticoagulation]] | ||
| + | |||
| + | ==History of changes in FDA indication== | ||
| + | *2018-05-04: Approved for patients treated with [[Rivaroxaban (Xarelto)|rivaroxaban]] and [[Apixaban (Eliquis)|apixaban]], when reversal of anticoagulation is necessary due to fatal or uncontrolled bleeding. | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2022-03-28: Newly indicated for the reversal of anticoagulant effect in life-threatening or uncontrolled bleeding in patients treated with a direct-acting factor Xa inhibitor (apixaban, rivaroxaban, or edoxaban tosilate hydrate). | ||
=Also known as= | =Also known as= | ||
| − | *'''Code name:''' | + | *'''Code name:''' PRT-4445 |
| − | *'''Generic name:''' | + | *'''Generic name:''' coagulation factor Xa recombinant inactivated-zhzo |
| + | *'''Brand name:''' Andexxa, Ondexxya | ||
| + | ==References== | ||
| + | <references/> | ||
| − | [[Category: | + | [[Category:Drugs]] |
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
[[Category:Hematology medications]] | [[Category:Hematology medications]] | ||
[[Category:Hemostasis medications]] | [[Category:Hemostasis medications]] | ||
| − | [[Category: | + | [[Category:Recombinant medications]] |
| + | |||
| + | [[Category:FDA approved in 2018]] | ||
| + | [[Category:EMA approved in 2019]] | ||
| + | [[Category:PMDA approved in 2022]] | ||
Latest revision as of 00:59, 29 June 2024
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 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]
Diseases for which it is used
History of changes in FDA indication
- 2018-05-04: Approved for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is necessary due to fatal or uncontrolled bleeding.
History of changes in PMDA indication
- 2022-03-28: Newly indicated for the reversal of anticoagulant effect in life-threatening or uncontrolled bleeding in patients treated with a direct-acting factor Xa inhibitor (apixaban, rivaroxaban, or edoxaban tosilate hydrate).
Also known as
- Code name: PRT-4445
- Generic name: coagulation factor Xa recombinant inactivated-zhzo
- Brand name: Andexxa, Ondexxya