Antihemophilic Injection Prevents Bleeding after Surgery

An intravenous injection of an antihemophilic complex stops post-surgical bleeding in patients with Von Willebrand's disease.

Humate-P, a human dried and pasteurized factor VIII/von Willebrand factor complex, is intended for the prevention of excessive bleeding during and after surgery in patients with severe von Willebrand's disease. It may also be used in settings of mild to moderate von Willebrand's disease where the use of desmopressin is known or suspected to be inadequate.

Although the product is purified from human plasma donated by carefully screened and tested U.S. donors and undergoes multiple processing steps for viral inactivation, the potential risk for transmission of blood-borne viruses (and theoretically, the Creutzfeldt-Jakob's disease agent) cannot be totally eliminated.

Humate-P, a product of CSL Behring (Marburg, Germany) has been previously approved by the U.S. Food and Drug Administration (FDA) for the treatment of spontaneous and trauma-induced bleeding episodes in adults and children with von Willebrand's disease and the treatment and prevention of bleeding in adults with hemophilia A. The new approval was based on data from two clinical studies, one conducted in the United States and the other in Europe. The results showed that the efficacy of antihemophilic factor/von Willebrand factor complex was classified by investigators as good or excellent in 61 of the 62 study patients.

Von Willebrand disease is the most commonly inherited bleeding disorder, affecting about 1-2% of the population of the United States. Common symptoms include heavy, prolonged menstrual bleeding; frequent nosebleeds; and easy bruising. Patients with von Willebrand's disease may require special care during dental procedures, surgery, and childbirth.


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