Proven Efficacy

Connect to effective hemophilia A treatment1

Effective in minimally treated and previously untreated patients

In a clinical study of 61 patients:
  • 88% of the bleeds (N=1047) were controlled with only 1 or 2 infusions (73% and 15% respectively).
  • Hemostasis was rated as “excellent” or “good” by the surgeon or treating physician in 100% of surgical procedures (N=27).

Hemostatic control achieved in previously treated hemophilia A patients

In a clinical study of 73 patients:
  • 92.7% of the bleeds (N=5,684) were treated with only 1 or 2 infusions (79.7% and 13% respectively).
  • Hemostasis was rated as “excellent” or “good” by the surgeon or treating physician in 100% of surgical procedures (N=41).

Prophylaxis and joint damage risk reduction in children (0-16yrs) with no pre-existing joint damage (N=65)

Routine prophylaxis demonstrates an 83% relative 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 had:
    • Approximately 8 times fewer joint hemorrhages and over 5 times fewer total hemorrhages

Next: Proven Safety»

Reference: 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

You should not use Helixate FS if you are allergic to rodents (like mice and hamsters) or are allergic to any ingredients in Helixate FS.

Tell your healthcare provider if you have been told you have heart disease or are at risk for heart disease.

You could have an allergic reaction to Helixate FS. Call your healthcare provider right away and stop treatment if you get rash or hives, itching, tightness of the chest or throat, difficulty breathing, light-headed, dizziness, nausea or a decrease in blood pressure.

Your body can make antibodies, called "inhibitors," against Helixate FS, which may stop Helixate FS from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.

Other common side effects of Helixate FS are local injection-site reactions (pain, swelling, irritation at infusion site) and infections from implanted injection device. Tell your healthcare provider about any side effect that bothers you or does not go away.

Call your healthcare provider right away if bleeding is not controlled after using Helixate FS.


Helixate FS, Antihemophilic Factor (Recombinant), is medicine used to replace the clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A.

Helixate FS is used to treat and control bleeding in adults and children with hemophilia A. Your healthcare provider may give you Helixate FS when you have surgery. Helixate FS can reduce the number of bleeding episodes in adults and children when used regularly (prophylaxis), and can reduce the risk of joint damage in children without preexisting joint damage when used regularly.

Helixate FS is not used to treat von Willebrand disease.

Please see the full Prescribing Information for HELIXATE FS, including approved patient labeling.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.