Safety

Manufacturing plasma therapies is a complex process that takes about seven months from plasma donation to completion of the finished product. Throughout this process, safety and quality are our highest priorities.

CSL Behring owns its own plasma collection centers in the U.S. and Germany, all operated by our own subsidiary, ZLB Plasma Services. Once donors are qualified, their first donation is tested to ensure safety and quality and isn't released for processing until after a second donation is made by the same donor and found to be safe.

Serum samples from each unit of plasma are shipped to one of our state-of-the-art testing laboratories in Knoxville, Tenn., and Göttingen, Germany. Although our donors are carefully screened, we use many additional precautions and procedures before we approve the plasma for manufacturing. All plasma samples are tested for HIV, Hepatitis B, Hepatitis C, and other pathogens. Any units that test positive for a virus are discarded.

The multiple steps that CSL Behring takes during the Humate-P^® manufacturing process helps to ensure that viruses are removed or inactivated during manufacture.^1,2

At each of CSL Behring's three manufacturing sites, thousands of units of plasma are combined into a plasma "pool" and tested again. After packaging, regulatory authorities check each lot before approving it for release.

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^®.

References

1. Data on file, 2005, CSL Behring LLC.
2. Lillicrap D, Poon M-C, Walker I, Xie F, Schwartz BA, and members of the Association of the Hemophilia Clinic Directors of Canada. Efficacy and safety of the factor VIII/von Willebrand factor concentrate, Haemate-P/Humate-P: ristocetin cofactor unit dosing in patients with von Willebrand disease. Thromb Haemost. 2002;87:224-230