Important Safety Information for Humate-P^®

Humate-P^® is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations.

Thromboembolic events have been reported in VWD patients receiving coagulation factor replacement, especially in the setting of known risk factors for thrombosis. Caution should be exercised and antithrombotic measures should be considered.

Humate-P^® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Although few adverse reactions have been reported in patients receiving Humate-P^®, the most commonly reported are allergic-anaphylactic reactions, including urticaria (hives), chest tightness, rash, pruritus (itching), edema (swelling), shock, chills and fever, and hypervolemia (abnormally high blood volume).

Please see full prescribing information for Humate-P^®.

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.

Important Safety Information for Helixate^® FS

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.

For more information about Helixate^® FS, 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.