New Recombinant Factor IX Product Approved by FDA
By Leigh Carpenter, RPh, Director of Pharmacy
Emergent BioSolutions Inc. has announced the FDA approval of IXINITY®, a recombinant factor IX product for adults and children at least 12 years of age with hemophilia B. It is approved for control and prevention of bleeding episodes and for perioperative management. The approval is based on a clinical trial which showed an average recovery of 0.98IU/dL and an average half-life of 24 hours. In this study, 84% of bleeds were resolved by one or two infusions of IXINITY. This is not considered a “long-acting” factor IX product. According to the manufacturer, IXINITY contains proteins derived from Chinese hamster ovary cells, with no human or animal proteins used in the manufacturing process. IXINITY is available in 500, 1000, and 1500 IU single-use vials and can be stored at 36 to 77 degrees Fahrenheit. The reconstituted solution should be infused within 3 hours after mixing. Each vial will be available in a pre-assembled kit with a prefilled diluent syringe and vial of factor. The Mix2Vial®needleless access device is also included, along with a 20ml Luer-LOKTM administration syringe. The diluent volume of each assay size is 5mls. If you are interested in trying IXINITY, please contact your hematologist or your Hemophilia Treatment Center since a new prescription is required by the Hemophilia of Georgia and Beacon pharmacies.