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Helixate® FS

Antihemophilic Factor (Recombinant)
Formulated with Sucrose

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.

Helixate® FS

Safety

  • No albumin is used in the formulation or purification processes
  • Solvent/detergent viral inactivation step

Confidence

  • Native full-length FVIII molecule
  • Demonstrated clinical performance; in 94% of bleeding episodes, results with Helixate® FS were rated as excellent or good with 1-2 infusions1

Convenience

  • Small 2.5 mL diluent for 250 IU, 500 IU, and 1000 IU strengths
  • Simple reconstitution with the Mix2VialTM
  • Less risk of accidental injury
  • Less time to prepare product
  • Simple process encourages independence
  • Built-in filter
  • For use with all BD Luer-LokTM syringes
  • Color-coded panels
  • Peel-off labels
  • Up to three months storage at room temperature (not to exceed 77°F [25°C] )

Helixate® FS is manufactured by Bayer Corporation and distributed by CSL Behring. The technical information within has been provided by Bayer. Mix2Vial is a trademark of Medimop Medical Projects Ltd. Luer-Lok is a trademark of Becton, Dickinson and Company.

NDC Number Product Description Diluent Size
0053-8131-02 Approximately 250 IU per bottle 2.5 mL
0053-8132-02 Approximately 500 IU per bottle 2.5 mL
0053-8133-02 Approximately 1000 IU per bottle 2.5 mL
0053-8134-02 Approximately 2000 IU per bottle 5 mL
0053-8135-02 Approximately 3000 IU per bottle 5 mL

Important Safety Information

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 full prescribing information.

Reference: 1. Abshire TC, Brackmann HH, Scharrer I, et al, and the International Kogenate-FS Study Group. Sucrose formulated recombinant human antihemophilic factor VIII is safe and efficacious for treatment of hemophilia A in home therapy. Thromb Haemost. 2000;83:811-816.

CUSTOMER SUPPORT 1-800-683-1288 or Customer Services

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.

Frequently Asked Questions for Helixate® FS

To learn more about Helixate® FS, please visit www.HelixateFS.com

Last Updated: 08 September 2009