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March 21, 2026

In Vitro Stability Study Supports the Use of Efmoroctocog Alfa and Rurioctocog Alfa Pegol for Continuous Infusion in Hemophilia A

GPGianna PastoreRoyal Brisbane and Women's Hospital RLRichard De LepervancheRoyal Brisbane and Women's Hospital JMJane MasonThe University of Queensland

Key Points

This study evaluates the in vitro stability of efmoroctocog alfa and rurioctocog alfa pegol over a 5-day period.
Triplicate samples of efmoroctocog alfa and rurioctocog alfa pegol were prepared.
Samples were diluted in FVIII-deficient plasma to achieve a baseline FVIII activity.
Assessment included integrity checks and FVIII assays at various time points: 0, 3, 6, 12, 24, 48, 72, and 96 hours.
FVIII activity remained stable over the 96-hour period post-reconstitution.
Average FVIII activity was 1.03 ± 0.17 U/mL for efmoroctocog alfa.
Average FVIII activity was 1.06 ± 0.12 U/mL for rurioctocog alfa pegol.
Both products showed feasibility for continuous infusion.

Abstract

Efmoroctocog alfa (ELOCTATE) and rurioctocog alfa pegol (ADYNOVATE) are extended half-life (EHL) recombinant human coagulation factor VIII (rFVIII) products indicated for the prophylaxis of bleeding and in the perioperative setting in patients with hemophilia A. Continuous infusion (CI) using a standard half-life (SHL) rFVIII is an established alternative to bolus infusion (BI) for surgical procedures or major bleeds and has several advantages over BI, including the ability to maintain stable FVIII levels and cost savings due to reduced product usage. There is no published stability data for efmoroctocog alfa and rurioctocog alfa pegol, and the manufacturers currently recommend the use of rurioctocog alfa pegol via BI within 3 hours of reconstitution and efmoroctocog alfa via BI within 6 hours of reconstitution. The aim of this study was to determine the in vitro stability of efmoroctocog alfa and rurioctocog alfa pegol over a 5-day period. Triplicate samples of efmoroctocog alfa and rurioctocog alfa pegol were tested. After reconstitution, the product was diluted in FVIII-deficient plasma to achieve a baseline FVIII activity of 0.8 to 1.2 U/mL. Assessment of sample integrity and one-stage FVIII assays were performed on each sample at 0, 3, 6, 12, 24, 48, 72, and 96 hours. The in vitro FVIII did not decrease over the 96 hours following reconstitution. The average FVIII activity for efmoroctocog alfa was 1.03 ± 0.17 U/mL, and the average FVIII activity for rurioctocog alfa pegol was 1.06 ± 0.12 U/mL. Efmoroctocog alfa and rurioctocog alfa pegol demonstrated stability for 96 hours. This suggests that CI would be feasible for these EHL products.

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