title: Recombinant Factor VIIa-Mediated Activation of Prothrombin Complex Concentrates.
abstract: Recombinant factor VIIa (rFVIIa) is used in the management of bleeding in patients with hemophilia. A generic biosimilar version of NovoSeven is also developed (AryoSeven). To compare the activation profile of NovoSeven and AryoSeven, 2 commercially available protein complex concentrates (PCCs) were used. Profilnine activated by RecombiPlasTin 2G resulted in conversions of prothrombin to prethrombin and thrombin at 5 to 30 minutes. However, addition of rFVIIa at final concentration range of 0.25 to 0.5 µg/mL to the same mixture resulted in total conversion of prothrombin to thrombin with a doublet at 36 kDa. Recombinant factor VIIa alone did not generate thrombin in native Beriplex, and the addition of rFVIIa to Beriplex failed to generate thrombin. Beriplex activated by RecombiPlasTin 2G resulted in complete conversion of prothrombin to thrombin. Both NovoSeven and AryoSeven exhibited similar activation profiles. These studies indicate that the activation of PCCs by both rFVIIa preparations results in comparable generation of thrombin.
authors.affiliation: 1 Loyola University Medical Center, Maywood, IL, USA.
authors.forename: Nasiredin
authors.initials: N
authors.lastname: Sadeghi
authors.affiliation: 2 Massimo Iacobelli, MD - Techitra Srl - Milano, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Iacobelli
authors.affiliation: 3 Pasteur Institute of Iran, Tehran, Iran.
authors.forename: Behroz
authors.initials: B
authors.lastname: Vaziri
authors.affiliation: 1 Loyola University Medical Center, Maywood, IL, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Kahn
authors.affiliation: 1 Loyola University Medical Center, Maywood, IL, USA.
authors.forename: Debra
authors.initials: D
authors.lastname: Hoppensteadt
authors.affiliation: 4 Ondokuz Mayis University, Samsun, Turkey.
authors.forename: Nil
authors.initials: N
authors.lastname: Guler
authors.affiliation: 1 Loyola University Medical Center, Maywood, IL, USA.
authors.forename: Jawed
authors.initials: J
authors.lastname: Fareed
mesh_terms: D001779:Blood Coagulation Factors / Q000187:drug effects*; D015942:Factor VIIa / Q000494:pharmacology*; D006470:Hemorrhage / Q000188:drug therapy; D006801:Humans; D011516:Prothrombin / Q000187:drug effects / Q000378:metabolism; D011994:Recombinant Proteins / Q000494:pharmacology; D013917:Thrombin / Q000378:metabolism
chemical_list: D001779:Blood Coagulation Factors; D011994:Recombinant Proteins; C025667:prothrombin complex concentrates; D011516:Prothrombin; C012007:prethrombins; C103587:recombinant FVIIa; D015942:Factor VIIa; D013917:Thrombin
keywords: PCCs; RCP; rFVIIa