Proven Safety

Proven Recombinant Technology1

Connect to well-established quality and product safety

A process that uses multiple steps designed to purify recombinant factor VIII (rFVIII) preparations

Phase 1 Fermentation (expression of the gene)
  • Continuous perfusion processing
    • Creates a consistent environment for gene expression through a high degree of cell culture control that goes beyond basic parameters (oxygen, pH, temperature)
Phase 2 Purification process
  • The rFVIII molecule is separated from the host cells in multiple chromatographic steps, including:
    • Ion exchange chromatography, which separates rFVIII molecule from impurities
    • Immunoaffinity chromatography, which separates rFVIII from most of the other proteins
    • Solvent/detergent virus inactivation, which inactivates viruses without damaging the structure of the rFVIII molecule
Phase 3 Formulation
  • Formulated without albumin
    • Final formulation stabilizes the rFVIII molecule using sucrose instead of albumin
  • No animal proteins added
  • No human proteins added during purification or to the final formulation*

*The baby hamster kidney cell line used to produce Helixate® FS is grown in a culture medium that contains human plasma protein.


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Reference: 1.
Freudenberg W, inventor; Behringwerke Aktiengesellschaft, assignee. Stabilized factor VIII preparations. US Patent 5,565,427. October 15, 1996.


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.