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Helixate^® FS Treatment Safety

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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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.

Helixate® FS Treatment Safety

Helixate^® FS Treatment Safety