KOVALTRY®

FDA INDICATION: For use in adults and children with hemophilia A (congenital factor VIII deficiency) for: on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Package Insert

CLASS: Recombinant

DISTRIBUTOR: Bayer HealthCare

ASSAY SIZE (IU): 250, 500, 1000, 2000, 3000

DILUENT SIZE: 2.5 mL pre-filled syringe (250 IU, 500 IU, 1000 IU), 5.0 mL pre-filled syringe (2000 IU, 3000 IU)

MIXING DEVICE: Vial adapter

ROOM TEMPERATURE STORAGE: Up to 12 months

HALF-LIFE (CHROMOGENIC SUBSTRATE ASSAY): 12.1 ± 2.7 hours (0 to <6 years), 12.0 ± 2.1 hours (6 to <12 years), 14.4 ± 5.5 hours (children 12 to 17 years), 14.2 ± 3.5 hours (≥18 years)

OTHER WEBSITES: livingwithhemophilia.com, pharma.bayer.com, kovaltry-us.com