FDA approves Bayer's new Kogenate FS storage option for hemophilia A treatment

Bayer HealthCare Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved a new storage option for Kogenate® FS, antihemophilic factor (recombinant), now allowing the product to be stored at room temperature (up to 77 degrees F) for up to one year.  Compared with the previous three-month room temperature option, this new storage option for Kogenate FS offers added convenience for patients with hemophilia A and is immediately available to customers.

Factor VIII products are typically stored in the refrigerator and are stable at room temperature for a limited time.  With this new storage option, people who use Kogenate FS may have more flexibility for storing their medication whether they're at home or at school, at work or at play or when traveling. For some, the approval of this new storage option may free up refrigerator space or possibly eliminate the need for a separate "factor fridge."  

"As convenience with medication is important to people with hemophilia A, we're pleased to offer a new storage temperature option, which complements other convenience features, including Grab and Go packaging with BIO-SET®, a compact and complete reconstitution system for Kogenate FS," said Paul Bedard, Vice President/General Manager, Hematology, Bayer HealthCare Pharmaceuticals.  "This new option demonstrates Bayer's ongoing commitment to the hemophilia A community."

The starting date of room temperature storage for Kogenate FS should be clearly recorded on the unopened product carton.  Once stored at room temperature, the product must not be returned to the refrigerator.  The shelf-life then expires after the storage at room temperature (up to 12 months) or the expiration date on the product vial, whichever is earlier.