Anti-hemophilic factor (recombinant), plasma/albumin-free method (octocog-alpha; ADVATE(®)) in the management of hemophilia A

Removal of blood-based additives from recombinant clotting factor concentrates continues to be advocated by the hemophilia community due to the history of infectious disease transmission with previous blood-derived clotting factor concentrates. In 2003, octocog-alpha, antihemophilic factor (recombinant), plasma/albumin-free method (ADVATE(®)) was introduced, providing the first third-generation recombinant factor VIII (rFVIII) concentrate. Completed clinical trials have demonstrated ADVATE(®) to be safe and effective in adult and pediatric subjects utilizing both prophylactic and on-demand treatment regimens, and for perioperative hemostatic coverage. In the five completed studies involving more than 200 previously treated patients (PTPs), a single incidence of low-titer, non-persistent inhibitor was reported. Active post authorization safety surveillance (PASS) is being performed to expand the efficacy and safety profile of ADVATE(®) in routine clinical practice. Laboratory studies have documented the storage and post-reconstitution stability of ADVATE(®), conferring the desired versatility for home treatment. The evolving real-world experience and ongoing studies will provide further insight into ADVATE(®) pharmacokinetics, alternative prophylactic dosing regimens, methods for perioperative hemostatic management, and utility in immune tolerance induction. Experience with ADVATE(®), and its place in today’s treatment paradigm, is the focus of this article.