Helixate^® FS Treatment Safety

To date, there have been no confirmed cases of viral transmissions with
Helixate^® FS.¹ With proven safety, Helixate^® FS:

• Is a recombinant factor VIII (rFVIII) product formulated without albumin^* with no human proteins added during purification in the final formulation
  • Manufactured using advanced recombinant technology
• Has no animal proteins added during fermentation
• Undergoes rigorous viral inactivation processes
  • Solvent/detergent treatment

The solvent/detergent treatment is designed to kill enveloped viruses without damaging the valuable plasma proteins.

^*The baby hamster kidney cell line used to produce Helixate^® FS is grown in a culture medium that contains human plasma protein. No human proteins are added during purification in the final formulation.

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1. Data on file, Bayer Corporation