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The Helixate^® FS Difference

Helixate^® FS is an advanced recombinant factor VIII (rFVIII) product for the treatment of hemophilia A that provides:

An rFVIII product formulated without albumin^*
A small diluent size—2.5 mL for fast, easy infusions
- No rFVIII product has a smaller diluent size
An rFVIII product that is proven effective
An rFVIII product that is proven safe
- Manufactured using advanced recombinant technology
An rFVIII product with rigorous viral inactivation
- Solvent/detergent treatment
A comprehensive range of services and support programs.

Helixate^® FS is now packaged with the Mix2Vial^™, a needle-free transfer device. With its small diluent of 2.5 mL and the Mix2Vial^™ needle-free transfer device, the Helixate^® FS Difference means maximum convenience with short infusion time.

Try Helixate^® FS to learn why you should switch. By participating in FactorPlus - the Helixate^® FS free trial program, patients receive 6 doses or up to 20,000 IU of Helixate^® FS!

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.

^*The baby hamster kidney cell line used to produce Helixate^® FS is grown in a culture medium that contains human plasma protein. No human proteins are added during purification or in the final formulation.

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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.

The Helixate® FS Difference

The Helixate^® FS Difference