Hemophilia is an inherited bleeding disorder characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs.
The 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 Helixate FS users.
Starting in November 2005, each package of Helixate FS will include a special notification with details on the new labeling. While the new room temperature storage option may be used, ZLB Behring recommends refrigerating the medication whenever possible.