The FDA approved new storage guidelines for antihemophilic factor VII [recombinant] injection (Helixate FS and Kogenate FS) that enable the medication to be stored at room temperature, 77[degrees]F or 25[degrees]C, for up to 3 months. Recombinant factor VII injection is indicated for the treatment of hemophilia.
Test data demonstrated that the labeled potency of the product remained within specified limits through the expiration date.
The new guidelines provide users with greater flexibility and simplify storage options, but refrigeration is still recommended whenever possible. Products stored at room temperature should not be returned to refrigeration.
Helixate FS is a product of ZLB Behring; Kogenate FS is a product of Bayer Biological Products.