Established Hemophilia Treatment Safety

Connect to well-established quality and safety

A process that uses multiple steps designed to purify recombinant factors, including factor VIII (FVIII)1,2

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 albumin2
  • No animal proteins added
  • No human proteins added during purification or to the final formulation*

CSL Behring’s patented processes in action during recombinant factor development1,2


Helixate FS: Purification and virus inactivation

Connect him to safety supported by clinical trials

Low rate of drug-related adverse events in minimally treated and previously untreated patients

Twenty-nine of the 726 adverse events were assessed as related to Helixate FS (0.3%). Adverse reactions in patients with frequency ≥4% (N=61):

  • Skin and subcutaneous disorders, 16.4%
  • Blood and lymphatic system disorders, 15%
  • General disorders and administration site conditions, 6.6%

Low rate of drug-related adverse events in previously treated patients

Twenty-four of the 451 adverse events were assessed as related to Helixate FS (0.1%). Adverse reactions in patients with frequency ≥4% (N=73):

  • Skin and subcutaneous disorders, 8.2%
  • General disorders and administration site conditions, 4.1%

Low incidence of inhibitor development

  • In minimally treated and previously untreated patients, the incidence of inhibitor development with Helixate FS was 15% (N=61)
    • Based on studies from around the world, it is estimated that the incidence of inhibitor development in patients with severe or moderately severe hemophilia A is between 20% and 33%3
  • In previously treated patients, the incidence of new inhibitor development was 0% (N=73)
  • In the Joint Outcome Study, which was conducted to demonstrate the effectiveness of routine prophylaxis for prevention of joint damage in children, the incidence of new inhibitor development was 12.5% (N=65)

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

1. Data on file. CSL Behring LLC.

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

3. DiMichele D. Inhibitors in Hemophilia: A Primer. 4th ed. Montreal: World Federation of Hemophilia; 2008. Treatment of Hemophilia; no 7.

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.