FDA Approves Room Temperature Storage of Kogenate FS
Bayer Receives FDA Approval for Room Temperature Storage of Kogenate FSExtended Storage Labeling Provides Greater Flexibility for Individuals Living with Hemophilia A
BERKELEY, Calif. October 6, 2005 - The Biological Products Division of Bayer HealthCare, LLC., (Bayer BP) announced today that Kogenate FS (Antihemophilic Factor (Recombinant), Formulated with Sucrose) received approval to be stored at room temperature (77 degrees F, 25 degrees C) for up to three months. The new storage guidelines for the treatment will provide users with greater flexibility and simplify storage options.
The United States Food and Drug Administration (FDA) approved the storage labeling change based on data from testing to assure the labeled potency (number of recombinant FVIII units contained in a vial) remains within specified limits through the expiration date of the product. The room temperature storage option is expected to be a significant convenience for Kogenate FS users. "As a busy mom, the new room temperature storage feature will make managing my son's treatment easier," said Chris Barnes, mother of a three-year-old boy with hemophilia A. "Storage convenience is important for us, especially when we head out on extended vacations. I feel this is a significant development for Kogenate FS users."
Starting in November 2005, each package of Kogenate FS will include a special notification with details on the new labeling. While the new room temperature storage option may be used, Bayer recommends refrigerating (36 degrees - 46 degrees F, 2 degrees - 8 degrees C) Kogenate FS whenever possible. It also is important to note that product stored at room temperature should not be returned to refrigeration. Kogenate FS users who may have additional questions about storage requirements for their existing product inventory should call Bayer Clinical Communications at 800-288-8371 (option 3).
"We are pleased with the approval and the opportunity to provide our customers with this convenience," said Terry Tenbrunsel, Vice President, Sales and Marketing, Bayer BP. "Room temperature storage will be a great addition to our overall Kogenate FS product offering. Along with other product features such as the 2.5 mL low volume diluent and the EZ-Log handheld electronic patient diary, this new labeling will provide greater freedom and allow individuals with hemophilia A to lead full, active, and productive lives."
About Kogenate FS
Kogenate FS (Antihemophilic Factor (Recombinant), Formulated with Sucrose), is a recombinant factor VIII treatment for hemophilia A that offers a more convenient administration by utilizing a 2.5 mL volume diluent, one of the smallest among available factor VIII products. Kogenate FS does not use albumin in its purification or formulation and includes a solvent/detergent viral inactivation step. Kogenate FS is manufactured at Bayer BPs state-of-the-art biotechnology facility in Berkeley, Calif. The most frequently reported adverse event was local injection site reactions. Known hypersensitivity to mouse or hamster protein may be a contraindication to the use of Kogenate FS. For additional details, see full prescribing information. Visit www.KogenateFS.com for additional information on Kogenate FS and its programs.
Hemophilia is an inherited bleeding disorder characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. About 17,000 Americans have hemophilia. The disease is caused by deficient or defective blood coagulation proteins, known as factor VIII or IX. The most common form of the disease is hemophilia A, or classic hemophilia, in which the clotting factor VIII is either deficient or defective. Hemophilia B is characterized by deficient or defective factor IX.
Posted: October 2005