title: Room-temperature-stable recombinant activated coagulation factor VII recombinant: chemical and microbiologic stability over 24 hours during continuous in vitro infusion.
abstract: rFVIIa-25C is a recombinant coagulation factor VIIa (rFVIIa) formulated to remain stable at room temperature (up to 25°C) for up to 2 hours. The bolus injection of rFVIIa-25C has been reported to be bioequivalent to that of rFVIIa. With alternative administration by continuous infusion (50 μg/kg/h) for surgical hemostatic coverage in hemophilia patients with inhibitors, rFVIIa has been reported to be stable. This research letter presents data from an in vitro study of the activity and chemical stability (rFVIIa content, clot activity, and degradation products), physical stability, and microbiologic stability of rFVIIa-25C administered as a continuous infusion. The findings suggest that rFVIIa-25C remained biochemically stable and aseptic during 24-hour continuous infusion in vitro at 19.3°C to 20.7°C, with no clinically significant changes in clot activity, solution constituents, or concentrations.
authors.affiliation: Novo Nordisk A/S, Gentofte, Denmark.
authors.forename: Abeline
authors.initials: A
authors.lastname: Christensen
authors.forename: Jane T
authors.initials: JT
authors.lastname: Jensen
authors.forename: Anne Mette
authors.initials: AM
authors.lastname: Nøhr
authors.forename: David L
authors.initials: DL
authors.lastname: Cooper
mesh_terms: D001777:Blood Coagulation / Q000187:drug effects; D001780:Blood Coagulation Tests; D002626:Chemistry, Pharmaceutical; D002850:Chromatography, Gel; D002851:Chromatography, High Pressure Liquid; D056148:Chromatography, Reverse-Phase; D003029:Coagulants / Q000008:administration & dosage / Q000737:chemistry*; D004340:Drug Contamination / Q000517:prevention & control*; D016503:Drug Delivery Systems / Q000295:instrumentation; D004355:Drug Stability; D015942:Factor VIIa / Q000008:administration & dosage / Q000737:chemistry*; D006801:Humans; D007262:Infusions, Intravenous; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000737:chemistry; D013594:Syringes; D013696:Temperature; D013997:Time Factors
chemical_list: D003029:Coagulants; D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa