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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.