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Andexanet alfa for the reversal of factor Xa inhibitors.
Favresse, J; Hardy, M; van Dievoet, M A; Sennesael, A L; Douxfils, J; Samama, C M; Vornicu, O; Dincq, A S; Lessire, S; Mullier, F.
Afiliación
  • Favresse J; a Namur Thrombosis and Haemostasis Center, Hematology Laboratory , Université catholique de Louvain, CHU UCL Namur , Yvoir , Belgium.
  • Hardy M; b Department of Anesthesiology , CHU UCL Namur, Namur Thrombosis and Haemostasis Center, Université Catholique de Louvain , Yvoir , Belgium.
  • van Dievoet MA; c St-Luc University Hospital and Catholic University of Louvain, Department of Laboratory Medicine , Hematology Laboratory , Brussels , Belgium.
  • Sennesael AL; d Department of Pharmacy , Namur Thrombosis and Haemostasis Center, Namur Research Institute for Life Sciences , Namur , Belgium.
  • Douxfils J; d Department of Pharmacy , Namur Thrombosis and Haemostasis Center, Namur Research Institute for Life Sciences , Namur , Belgium.
  • Samama CM; e Qualiblood s.a. , Namur , Belgium.
  • Vornicu O; f Department of Anaesthesiology and Intensive Care Medicine, Cochin University Hospital , Paris Descartes University , Paris , France.
  • Dincq AS; b Department of Anesthesiology , CHU UCL Namur, Namur Thrombosis and Haemostasis Center, Université Catholique de Louvain , Yvoir , Belgium.
  • Lessire S; b Department of Anesthesiology , CHU UCL Namur, Namur Thrombosis and Haemostasis Center, Université Catholique de Louvain , Yvoir , Belgium.
  • Mullier F; b Department of Anesthesiology , CHU UCL Namur, Namur Thrombosis and Haemostasis Center, Université Catholique de Louvain , Yvoir , Belgium.
Expert Opin Biol Ther ; 19(5): 387-397, 2019 05.
Article en En | MEDLINE | ID: mdl-30974977
INTRODUCTION: Andexanet alfa is a recombinant modified factor Xa protein that has been developed to reverse factor Xa inhibitors. Since May 2018, the FDA has approved its utilization in patients treated with apixaban and rivaroxaban in case of life-threatening or uncontrolled bleeding. On 28 of February 2019, the Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a conditional marketing authorization for andexanet alfa in Europe. Area covered: The authors provide an overview of andexanet alfa development and its pharmacokinetic and pharmacodynamic properties. The results of the clinical phase III trial ANNEXA as well as current limitations related to andexanet alfa are also discussed. Expert opinion: Although phase I and II studies have proven that andexanet alfa can be effective in reversing the effect of factor Xa inhibitors, its efficacy in major bleeding patients has only been shown for apixaban and rivaroxaban, without any comparator group. Well-designed studies comparing the efficacy and safety of andexanet alfa to other reversal strategies are required to confirm preliminary data. The benefit of andexanet alfa in specific settings needs to be investigated and its use in clinical practice needs to be facilitated by the implementation of international guidelines.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Proteínas Recombinantes / Factor Xa / Inhibidores del Factor Xa / Hemorragia Tipo de estudio: Guideline Límite: Humans Idioma: En Revista: Expert Opin Biol Ther Asunto de la revista: BIOLOGIA / TERAPEUTICA Año: 2019 Tipo del documento: Article País de afiliación: Bélgica Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Proteínas Recombinantes / Factor Xa / Inhibidores del Factor Xa / Hemorragia Tipo de estudio: Guideline Límite: Humans Idioma: En Revista: Expert Opin Biol Ther Asunto de la revista: BIOLOGIA / TERAPEUTICA Año: 2019 Tipo del documento: Article País de afiliación: Bélgica Pais de publicación: Reino Unido