The Helixate® FS Difference

Helixate® FS is a recombinant FVII (rFVIII) product for the treatment of Hemophilia A that provides:

  • Proven efficacy in previously untreated patients and previously treated patients
  • Well-established quality and safety profile for hemophilia treatment
    • Recombinant technology and multiple purification steps reduce the risk of virus transmission
  • Maximum Convenience that fits the needs of an active person living with hemophilia A
    • 3000 IU/5.0 mL diluent* makes reconstitution easier for higher doses
    • Mix2VialTM facilitates reconstitution of Helixate® FS
  • Technology that connects healthcare providers to their patients
    • The HeliTrax® System: Wireless technology that meets the needs of the treatment team while helping physicians track their hemophilia A patients’ progress

*250 IU, 500 IU, and 1000 IU require 2.5 mL diluents. 2000 IU and 3000 IU doses require 5.0 mL diluent.

If you have questions or would like more information about Helixate® FS, please call our Medical Affairs Department at 1-800-504-5434 or e-mail us.

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Important Safety Information

Helixate® FS, Antihemophilic Factor (Recombinant), is a recombinant factor VIII treatment indicated for the control and prevention of bleeding episodes and peri-operative management in adults and children (0-16 years) with hemophilia A. Helixate® FS is also indicated for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no preexisting joint damage.

The most serious adverse reactions are systemic hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to antihemophilic factor. The most common adverse reactions observed in clinical trials were inhibitor formation in previously untreated or minimally treated patients, skin-associated hypersensitivity reactions, infusion site reactions, and central venous access device (CVAD) line-associated infections.

Helixate® FS is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including mouse or hamster proteins.

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.