The U.S. FDA has approved an expanded indication for Rebinyn® [coagulation factor IX (recombinant), glycopegylated]. The product is now indicated for routine prophylaxis to reduce the frequency of bleeding episodes in adults and children who have hemophilia B (congenital factor IX deficiency).
- Originally FDA approved in 2017, Rebinyn is also indicated for use in adults and children who have hemophilia B to provide on-demand treatment and control of bleeding episodes, as well as perioperative management of bleeding.
- The recommended dosing for routine prophylaxis is 40 IU/kg of the patient’s body weight administered via intravenous injection once weekly.