FDA Approves New Storage Option for Kogenate FS

The FDA has approved a new storage option for Kogenate FS (recombinant factor VIII; Bayer HealthCare). Compared with the previous three-month room temperature option, the new option allows for storage of Kogenate FS at room temperature (up to 77°F) for up to one year. The new storage option is effective immediately for existing supplies of Kogenate FS. Once stored at room temperature, the date should be clearly recorded on the unopened product carton and must not be returned to the refrigerator. The product then expires after 12 months of storage at room temperature or the expiration date on the product vial, whichever is earlier.

Kogenate FS is a recombinant factor VIII treatment indicated for the control and prevention of bleeding episodes and perioperative management in adults and children (0–16 years) with hemophilia A. Kogenate FS is also indicated for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no preexisting joint damage.

For more information call (888) 84-BAYER or visit www.kogenatefs.com.