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.

In over 20 years and more than one-half billion units infused, there is no documented evidence of viral transmission with Humate-P^®1

Important Safety Information

Humate-P is indicated for treatment and prevention of bleeding in adult patients with 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 not indicated for the prophylaxis of spontaneous bleeding episodes.

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

Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses. Also monitor VWF:RCo and FVIII levels in VWD patients, especially those undergoing surgery.

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

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

In patients receiving Humate-P in clinical studies for treatment of VWD, the most commonly reported adverse reactions observed by >5% of subjects are allergic-anaphylactic reactions, including urticaria (hives), chest tightness, rash, pruritus (itching), and edema (swelling). For patients undergoing surgery, the most common adverse reactions are postoperative wound or injection-site bleeding, and epistaxis (nosebleed).

Please see 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.

References

Data on file, 2005, CSL Behring LLC.
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