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Safety

Unwavering focus on viral safety
The Humate-P® pasteurization process is proven to inactivate enveloped and non-enveloped viruses in one complete step*1,2

The addition of stabilizing agents (removed later in the manufacturing process) preserves the von Willebrand factor high molecular weight multimers of Humate-P®.3

In over 20 years and more than one-half billion units infused, there are no confirmed cases of viral transmission with Humate-P®1.

Please see Important Safety Information about Humate-P®.


Important Safety Information

Antihemophilic Factor/von Willebrand Factor Complex (Human), Dried, Pasteurized, Humate-P® is indicated in adult patients for treatment and prevention of bleeding in hemophilia A (classical hemophilia). Humate-P® is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for (1) treatment of spontaneous and trauma-induced bleeding episodes, and (2) prevention of excessive bleeding during and after surgery. This applies to patients with severe VWD, and patients with mild and moderate VWD for whom use of desmopressin is known or suspected to be inadequate.

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

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 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 the most common are allergic-anaphylactic reactions, including urticaria, chest tightness, rash, pruritus, edema, shock, chills and fever, and hypervolemia. For patients undergoing surgery, the most common adverse reactions are postoperative wound or injection-site bleeding.

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

The information provided herein is solely for use by physicians and healthcare professionals in the United States. The CSL Behring product listed may not have been approved in other countries and may not be available everywhere.

References

  1. Data on file, 2005, CSL Behring LLC.
  2. Mannucci PM. Treatment of von Willebrand's disease. N Engl J Med. 2004;351:683-694.
  3. Mauler R, Merkle W, Hilfenhaus J. Inactivation of HTLV-III/LAV, hepatitis B and non-A/non-B viruses by pasteurization in human plasma protein preparations. Dev Biol Stand. 1987;67:337-351.