Eptacog Alfa (Activated) Is Physically and Chemically Stable over 24 Hours when Administered as Bolus Injections in an Automated Infusion Pump.

 Eptacog alfa (activated) is a recombinant activated factor VII (rFVIIa) used for the treatment and prevention of bleeding episodes in patients with congenital hemophilia with inhibitors. Frequent dosing requirements make the use of an automated bolus infusion pump a promising alternative to manual administration.  The objective of this in vitro study was to evaluate the physical and chemical stability of room temperature-stable rFVIIa at 25°C over 24 hours in an automated bolus infusion pump.  An automated bolus infusion pump with preset bolus injection intervals of 2 to 6 hours was used. Samples of rFVIIa were analyzed for critical quality parameters, presence of leachables, and microbiological growth. The infusion system was evaluated visually.  rFVIIa is physically and chemically stable when used in an automated bolus infusion pump system for up to 24 hours at 25°C. All critical quality parameter results were within the shelf-life limits and complied with the acceptance criteria. Leachables were observed at concentrations within their respective acceptance criteria. No visual changes in the syringe or infusion tube were observed; inherent particles in the reconstituted rFVIIa similar in size and description to those previously found in rFVIIa were seen. No microbiological growth was detected.  rFVIIa is stable in a bolus infusion pump system for up to 24 hours at 25°C. Bolus injection intervals of 2 to 6 hours can be used without physical or chemical changes to rFVIIa. This study supports the use of an automated bolus infusion pump in the hospital setting, across all indications for rFVIIa.