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—Innovation Means Added Convenience for Patients and Caregivers—
King of Prussia, PA—February 15, 2006—CSL Behring today announced that Humate-P® (Antihemophilic Factor/von Willebrand Factor Complex (Human), Dried, Pasteurized) is now available featuring a smaller diluent — 50 percent less in all assay sizes.
The new formulation, which bears the current safety and efficacy profile of Humate-P, offers added convenience to patients, healthcare professionals, and caregivers who administer Humate-P. Humate-P is the only factor concentrate approved by the U.S. Food & Drug Administration for use in treating adult and pediatric patients who experience spontaneous and trauma-induced bleeding episodes in severe von Willebrand Disease (VWD), and in mild or moderate VWD where the use of desmopressin is known or suspected to be inadequate.1
"CSL Behring continually strives to bring innovation to the healthcare marketplace so we can offer products that enhance patients’ overall quality of life," said Paul Perreault, CSL Behring Executive Vice President, Worldwide Commercial Operations. "Humate-P with the smaller diluent is an excellent example of that effort. We are pleased to be bringing it to those patients who can benefit from the convenience it offers."
The smaller diluent size means that patients who use the new formulation can enjoy the convenience of spending less time receiving their infusions. In addition, vial and package sizes of the product are now smaller, translating to less required storage space.
About von Willebrand disease
Von Willebrand disease, the most common hereditary bleeding disorder in the United States, affects approximately 1 to 2% of the U.S. population.1 It is caused by a deficiency or abnormality of the 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 may 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 19 years of demonstrated safety and efficacy around the world. After more than one-half billion units infused, there is no documented evidence 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.
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 in 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 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.
About CSL Behring
CSL Behring is a global leader in the plasma protein biotherapeutics industry. Passionate about improving the quality of patients' lives, CSL Behring manufactures and markets a range of safe and effective plasma-derived and recombinant products and related services. The company's therapies are used in the treatment of immune deficiency disorders, hemophilia, von Willebrand disease, other bleeding disorders and inherited emphysema. Other products are used for the prevention of hemolytic diseases in the newborn, in cardiac surgery, organ transplantation and in the treatment of burns. The company also operates one of the world's largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia. For more information, visit www.cslbehring.com.
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1 Centers for Disease Control and Prevention. Bleeding Disorders.
Available at: http://www.cdc.gov/ncbddd/hbd/hemophilia.htm
Accessed: March 28, 2007
2National Heart Lung and Blood Institute. What Is von Willebrand Disease?
Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/vWD/vWD_All.html
Accessed: March 28, 2007
3National 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: March 28, 2007
4National Heart Lung and Blood Institute. Treatments for VWD.
Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/vWD/vWD_Treatments.html
Accessed: March 28, 2007
5Centers for Disease Control and Prevention. Bleeding and Clotting Disorders in Women.
Available at: http://www.cdc.gov/ncbddd/hbd/women.htm
Accessed: March 28, 2007
Contact:
Sheila A. Burke
Director, Communications & Public Relations, Worldwide Commercial Operations
CSL Behring
610-878-4209
Sheila.Burke@cslbehring.com
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© CSL Behring 2008. The product information presented on this site is intended for US residents only.
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