Bayer HealthCarePharmaceuticals has announced that the FDA hasapproved a 3000 IU (international unit) vial size of Kogenate FS,antihemophilic factor (recombinant). The new vial size offers greaterconvenience for patients with hemophilia A who require a higher dose.The 3000 IU vial may eliminate the need for combining smaller vials andmay allow some patients to achieve more precise dosing. It is available in aconventional vial-to-vial reconstitution system and in Kogenate FS Grab & Gopackaging with BIO-SET , a compact and complete reconstitution system. Grab &Go includes the Terumo SURFLO Infusion Set with filter and other materialsnecessary for safe reconstitution and fast recombinant factor VIII treatmentin a small, tamper-evident box with anticounterfeiting features. “The availability of Kogenate FS in a 3000 IU vial demonstrates Bayer’scommitment to adolescent and adult patients, who are more likely to have aneed for higher doses and who will appreciate the greater convenience of thelarger vial,” said Joni Osip, RN, MS, Hemophilia Nurse Coordinator, Center forBleeding and Clotting Disorders at the University of Minnesota Medical Center,Fairview, in Minneapolis. The Kogenate FS line of products now includes the following vial sizes:250, 500, 1000, 2000 and 3000 IU. Kogenate FS has one of the smallest diluentvolumes available. The 250, 500 and 1000 IU vial sizes are provided with 2.5mL of diluent; the 2000 and 3000 IU vial sizes are reconstituted with 5 mL ofdiluent. The 3000 IU vial size is now part of the Kogenate FS Free TrialProgram, which is open to people with hemophilia A who meet programeligibility criteria. “The 3000 IU vial size is being offered in response to customer needs andis part of Bayer’s ongoing efforts to introduce enhancements for the benefitof the people who are treated with Kogenate FS,” said Paul Bedard, VicePresident and General Manager, Hematology, Bayer HealthCare Pharmaceuticals.
