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 to remove viruses and other contaminiating substances
  • Convenient features 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


*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 product information about Helixate® FS, please contact us.

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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.

Indications

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 www.fda.gov/medwatch or call 1-800-FDA-1088.