both overall and into joints, and thus reduce the risk of joint dam- (NAPSA)—Arecently approved use of factor for hemophilia A treatment may help many of the thousands of children living with this rare but serious disease. Hemophilia A, also known as age in patients from infancy to age 16 who have hemophilia A and no pre-existing joint damage.” Theclinical study on which the approval was based was published in The New England Journal of factor VIII deficiency or classic hemophilia, is largely an inherited bleeding disorder in which one of Medicine’ and found: the proteins needed to form blood clots in the body is missing or reduced. The condition is charac- e Ninety-three percent of par- ticipants in the routine prophylaxis group had no joint damage terized by prolonged or spontaneous bleeding, especially into the muscles, joints or internal organs. as measured by magnetic reso- nance imaging (MRI) compared to 55 percent in the episodic group. Hemophilia A is the most com- The difference between the two backgrounds; it almost always alone. The prophylaxis group had mon type of hemophilia and affects people of all races and groups wassignificant when using MRI but not when using x-ray affects boys, while girls carry the gene. Approximately one in 5,000 males born in the United States has hemophilia A. Until now, treatments for hemophilia A have been approved for use episodically, prior to surgery and for short-term prevention of bleeding. But, based on the findings of a recent study, the FDA has now also approved Kogenate FS, antihemophilic factor (recombinant), for use in a pro- phylactic way in children with an 81.5 percent reduction in annual bleeding frequency comparedto the episodic group. Overall, eight of 64 patients A newly approved approach to treatment can help children with developed any level of inhibitors over the 5%-year study. Only two patients developed high-titer treatment regimen recommended by the National Hemophilia Foundation’s Medical and Scientific Advisory Council (MASAC). from the study. The most common a serious disorder. Prasad Mathew, M.D., director quency of bleeding episodes and of the Hemophilia Program at the University of New Mexico and coauthor of the Joint Outcomes approval, use of Kogenate FS is an impor- hemophilia A and no pre-existing joint damage to reduce the frerisk of joint damage. With this FDA Kogenate FS, manufactured by Bayer HealthCare LLC, is the first and only factor VIII treatment determined to be safe and effective for routine prophylaxis, a Study, said, “The approval of this tant development in the care of patients with hemophilia A, especially young children. This newly approved use can help reduce the frequency of bleeding episodes inhibitors and were withdrawn adverse events were related to central venous access, such as catheterization and catheter removal, central line infection and pyrexia. “The clinical study results show that administering the drug as indicated in the study to reduce the frequency of bleeding into the joints was more beneficial in reducing joint damage,” explained Dr. Mathew. For more information, visit www.kogenatefs.com/info. About Kogenate FS INDICATIONS Kogenate FS, antihemophilic factor (recombinant), is a recombinant factor VII treatment indicated for the control and prevention of bleeding episodes and perioperative management in adults and children (0-16 years) with hemophilia A. Kogenate FS is also indicated for routine prophylaxis to reduce the frequency of bleeding episodes and therisk ofjoint damage in children with hemophilia A with no pre-existing joint damage. IMPORTANT SAFETY INFORMATION The most serious adverse reactions are systemic hypersensitivity reactions and the developmentof high-titer inhibitors necessitating alternative treatments to AHF. The most common adverse reactions observed in clinical trials were inhibitor formation in previously untreated or minimally treated patients, skin-associated hypersensitivity reactions, infusion site reactions, and central venous access device (CVAD) line-associated infections. Kogenate FS is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including mouse or hamster proteins. 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. Please see the full prescribing information for important risk and use information at www.kogenatefs.com. *Manco-Johnson MJ, Abshire TC, Shapiro AD, et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med. 2007;357:535-44.
