Hemophilia Treatment Glossary

Adverse events (or adverse effects)
A reaction to or side effect from a medication

Albumin
A protein found in human or animal blood that is used to stabilize plasma and some recombinant products. In an effort to move away from human plasma, Helixate® FS uses sucrose instead of albumin to stabilize the final product

Chromatography
A process used to separate mixtures and purify one or some components of them

Diluent
An agent or substance used for dilution

Enveloped virus
A virus that has a covering, or envelope, over its outer shell, which is used to help the virus enter host cells

Excipient
An inactive or inert ingredient in a drug, usually used to bind the drug’s contents

Fermentation
Chemical process or conversion in which microorganisms are used to invoke a chemical change in cells

Formulation
The process or “recipe” for developing a drug

Inhibitor
Antibodies produced by the body’s immune system in response to factor VIII therapy. Inhibitors are then seen as foreign invaders by the immune system, making the factor VIII less effective

Lyophilize
To freeze-dry in a high vacuum

Recombinant
When blood proteins are synthesized in a laboratory instead of being extracted from blood. Recombinant FVIII does not contain the viruses that may be present in factor preparations derived from plasma (blood)

Reconstitute
To mix with a liquid, such as water, to return something to its original liquid form

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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.