Important Safety Information
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.