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Amy D ShapiroIndiana Hemophilia and Thrombosis Center, Indianapolis, IN, USAAbstract: 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, octocogalpha, 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.Keywords: ADVATE®, factor VIII, hemophilia, octocog-alpha |
