Corifact Approved by FDA for Treatment of Factor XIII Deficiency
Horizons in Hemophilia, March 2011
By Leigh Carpenter, RPh, Director of Pharmacy
CSL Behring announced that the FDA has granted approval for Corifact, factor XIII concentrate (human), for the routine prophylactic treatment of congenital factor XIII deficiency. It is estimated the condition affects one person in two million, with an incidence in the U.S. of approximately 150 people. The product has been available in 12 countries under the trade name Fibrogammin-P. Congenital FXIII deficiency is a rare bleeding disorder in which blood clots normally, but the clots formed are unstable. This can lead to recurrent bleeds and put patients at high-risk for intracranial hemorrhage.
Corifact is a heat-treated concentrate made from pooled human plasma. All plasma used in the manufacture of Corifact is obtained from US donors. It is given by intravenous (I.V.) infusion approximately every 28 days. The product is indicated for routine prophylactic treatment and there are no controlled studies demonstrating a direct benefit on treatment of bleeding episodes. Lab values should be drawn for subsequent dosing after an initial dose of 40 iu per kg body weight.
Development of inhibitors against FXIII has been detected and monitoring for this is recommended. The single-use vial contains 1000-1600 units of FXIII. It is packaged with a 20ml vial of sterile water for injection, Mix2Vial and alcohol swab.
Corifact stored in a refrigerator is stable for 24 months, up to the expiration date on the carton and vial labels. Within the expiration date, Corifact may be stored at room temperature not to exceed 77 degrees Fahrenheit for up to 6 months. After reconstitution, the product must be used within 4 hours.
Corifact has been approved for prophylactic treatment of congenital Factor XIII deficiency in adults and pediatric patients and will be available from the HoG pharmacy and Beacon Pharmacy. Please contact your Hemophilia Treatment Center for more information.