Important Safety Information

Helixate® FS is a recombinant factor VIII (FVIII) product used to treat hemophilia A when there is a demonstrated deficiency of FVIII, a plasma clotting factor.

Helixate® FS should be administered cautiously in patients with previous hypersensitivity to constituents of FVIII or known sensitivity to mouse or hamster protein.

Helixate® FS should not be used by people with von Willebrand disease because it does not contain von Willebrand factor—a different protein associated with a different bleeding disorder. For more information about von Willebrand disease, please visit www.AllAboutBleeding.com.

Adverse events are generally minor. The most common events include injection-site reactions, dizziness, and rash.

For more information about Helixate® FS, please see the full Prescribing Information.