Connect to effective hemophilia A treatment

Highly effective in minimally treated and previously untreated patients

In clinical studies:

  • 100% of bleeds (N=1047) were controlled with the hemophilia treatment Helixate FS — 88% of the bleeds were controlled with only 1 or 2 infusions.
  • Hemostasis was rated as “excellent” or "good" by the surgeon or treating physician in 100% of surgical procedures.

Hemostatic control achieved in previously treated hemophilia A, or classic hemophilia, patients

In clinical studies:

  • 100% of bleeds (N=5684) were controlled with Helixate FS — 92.7% of the bleeds were treated with only 1 or 2 infusions.
  • Hemostasis was rated as "excellent" or "good" by the surgeon or treating physician in 100% of surgical procedures.

Prophylaxis and joint damage risk reduction

Routine prophylaxis demonstrates an 83% reduction in risk of joint damage as compared to the risk in undergoing hemophilia treatment episodically.

  • Children treated episodically had 6 times the likelihood of proven damage to one or more joints as shown by MRI.
  • Children treated with routine prophylaxis had1:
    • Approximately 8 times fewer joint hemorrhages and over 5 times fewer total hemorrhages
    • No life-threatening bleeds, compared with approximately 9% (3 of 33 children) in the episodic group

Next: Established Safety »

1. Manco-Johnson MJ, Abshire TC, Shapiro AD, et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. Engl J Med. 2007;357(6):535-544.

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.