Important Safety Information for Helixate^®FS

Helixate^® FS, Antihemophilic Factor (Recombinant), is a recombinant factor VIII treatment indicated for the treatment of hemophilia A.

The most frequently reported adverse events were local injection-site reactions, dizziness, and rash.

Known intolerance or allergic reactions to constituents of the preparation is a contraindication to the use of Helixate^® FS. Known hypersensitivity to mouse or hamster protein may be a contraindication to the use of Helixate^® FS.

Please see the full prescribing information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.