Formula & Concentration
[Antihemophilic Factor (Recombinant)]
KOVALTRY®, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated 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, Routine prophylaxis to reduce the frequency of bleeding episodes.
KOVALTRY is not indicated for the treatment of von Willebrand disease (1).
Shelf Life and Storage
Product as Packaged for Sale Store KOVALTRY at +2°C to +8°C (36°F to 46°F) for up to 30 months from the date of manufacture. Do not freeze. Within this period, KOVALTRY may be stored for a single period of up to 12 months at temperatures up to +25°C or 77°F. Record the starting date of room temperature storage on the unopened product carton. Once stored at room temperature, do not return the product to the refrigerator. The shelf-life then expires after storage at room temperature for 12 months, or after the expiration date on the product vial, whichever is earlier. Do not use KOVALTRY after the expiration date indicated on the vial. Protect KOVALTRY from extreme exposure to light and store the vial with the lyophilized powder in the carton prior to use. Product After Reconstitution Administer reconstituted KOVALTRY as soon as possible. If not, store at room temperature for no longer than 3 hours. Do not use KOVALTRY if the reconstituted solution is cloudy or has particulate matter. Use the administration set provided.