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The FDA has approved Eloctate (Biogen), a recombinant factor VIII Fc fusion protein with an extended half-life, for use in adults and children with hemophilia A. Eloctate is indicated for control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. It is the first antihemophilic factor VIII Fc fusion protein to be approved for hemophilia A.
FACTOR VIII REPLACEMENT THERAPY — Regular injections of plasma-derived or recombinant factor VIII products are the standard of care for prevention of bleeding and joint destruction in patients with hemophilia A. Plasma-derived products have been associated with transmission of blood-borne viruses such as HIV, hepatitis B, and hepatitis C, but use of viral inactivation methods has eliminated most of this risk. Plasma-derived and recombinant factor VIII products are... more
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