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Patient and Healthcare Provider Convenience Focus of Packaging Enhancements for Humate-P from CSL Behring

 

King of Prussia, PA — 09 November 2009

CSL Behring has begun packaging Humate-P® (Antihemophilic Factor/von Willebrand Factor Complex [Human]) in a more user-friendly package based on customer market research. These packaging enhancements strive to improve the convenience of treatment for people with von Willebrand disease (VWD), the most common hereditary bleeding disorder in the United States. According to the Centers for Disease Control and Prevention, VWD affects approximately 1 to 2 percent of the U.S. population.

The packaging enhancements for Humate-P include:

  • The addition of an eco-friendly, recyclable tray to protect vials in transit and provide a secure space for reconstitution.
  • A peel-off label sticker for the 1200 IU (international unit) von Willebrand Factor:Ristocetin Cofactor (VWF:RCo) and 2400 IU VWF:RCo. vials of Humate-P. This new label sticker can be easily removed from the vials and placed in a log to simplify therapy record keeping for patients and their caregivers, making it easier to track the precise amount of factor being infused and the associated lot numbers.
  • A new box size that will allow for multiple boxes of Humate-P to be easily stacked, reducing the amount of space needed for storage.

"CSL Behring continually strives to improve the quality of our products for patients who depend on our therapies," said Robert Lefebvre, Vice President and General Manager, U.S. Commercial Operations at CSL Behring. "While these packaging enhancements will make administering, storing and recording Humate-P treatment more convenient, the product remains the same therapy that our patients have relied on to manage their VWD for more than 20 years."

For more information about Humate-P, please visit www.humate-p.com or call CSL Behring Consumer Affairs at 1-888-508-6978.

About von Willebrand disease
von Willebrand disease, the most common hereditary bleeding disorder in the United States, affects approximately 1 to 2 percent of the U.S. population.1 It is caused by a deficiency or abnormality of von Willebrand factor, a protein in the blood that is necessary for normal blood clotting.1 Men and women are equally likely to be affected by VWD.1 VWD is classified by type of defect, ranging from Type I (the most common and mildest) to Type III (the least common and most severe).2

Women with VWD are more likely than other women to experience heavy, prolonged menstruation.3 Other common symptoms of VWD include frequent nosebleeds and easy bruising.3 Bleeding can be mild or serious and can occur as a result of injury, or without an obvious cause.3 More serious symptoms include bleeding into joints and internal organs.3 An individual with any of the three types of VWD may require special care during dental procedures, surgery, and childbirth.4

There is no "cure" for VWD, but different situations can be treated effectively in different ways.5 Specific treatments can include: desmopressin acetate, which in patients with mild VWD can release stored von Willebrand factor; von Willebrand factor replacement therapies, such as Humate-P; and oral contraceptives, to reduce menstrual bleeding and to raise von Willebrand factor levels in the bloodstream.

About Humate-P 
Humate-P®, Antihemophilic Factor/von Willebrand Factor Complex (Human) Dried, Pasteurized, is a factor replacement therapy with more than 20 years of demonstrated safety and efficacy around the world. After more than one-half billion units infused, there have been no confirmed reports of viral transmission with Humate-P. It is an injectable product that works by replacing the von Willebrand factor/factor VIII missing in patients with VWD. Humate-P contains the high molecular weight of multimers of von Willebrand factor important for correcting the coagulation defect in patients with VWD. The distribution of high molecular weight multimers in Humate-P corresponds closely to that found in normal human plasma. For more information about Humate-P, please visit www.humate-p.com.

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. 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, 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 full prescribing information for Humate-P® at www.humate-p.com.

About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for people with rare and serious diseases, the company manufactures and markets a range of plasma-derived and recombinant therapies worldwide. CSL Behring therapies are indicated for the treatment of coagulation disorders including hemophilia and von Willebrand disease, primary immune deficiencies and inherited respiratory disease. The company’s products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic diseases in newborns. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company headquartered in Melbourne, Australia. For more information, visit www.cslbehring.com.

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Contacts:
Greg Healy, Senior Manager, Public Relations & Communications
U.S. Commercial Operations
CSL Behring
610-878-4841
Greg.Healy@cslbehring.com

1 Centers for Disease Control and Prevention. Bleeding Disorders.
Available at: http://www.cdc.gov/ncbddd/hbd/hemophilia.htm
Accessed: October 8, 2009

2 National Heart Lung and Blood Institute. Types of VWD.
Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/vWD/vWD_All.html
Accessed: November 5, 2009

3 National Heart Lung and Blood Institute. Signs and Symptoms of VWD.
Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/vWD/vWD_SignsAndSymptoms.html
Accessed: October 8, 2009

4 National Heart Lung and Blood Institute. Treatments for VWD.
Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/vWD/vWD_Treatments.html
Accessed: October 8, 2009

5 Centers for Disease Control and Prevention. Bleeding and Clotting Disorders in Women.
Available at: http://www.cdc.gov/ncbddd/hbd/women.htm
Accessed: October 8, 2009

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