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

Abstract

Introduction 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.

Aims 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.

Methods 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.

Results 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.

Conclusions 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.

Keywords

rFVIIa - eptacog alfa (activated) - congenital hemophilia with inhibitors - in-use stability - automated infusion - surgery

Authors' Contributions

All authors had access to data, were involved in preparation of and critically reviewed the manuscript, and approved the final manuscript. The research study was designed by P.R., J.T.J., N.B.S., and E.K. J.T.J. performed the research. N.B.S. and E.K. analyzed the data. Writing and editorial support was provided by AXON Communications, London, UK. Editorial support was funded by Novo Nordisk. This manuscript was developed in compliance with Good Publication Practice Guidelines.

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