Medication Monitor

Generic Name (Trade Name—Company)
March 1, 2011

Factor XIII concentrate (human)

(Corifact—CSL Behring)
Treatment of congenital deficiency


Routine prophylactic treatment of congenital factor XIII deficiency

The first and only factor XIII concentrate has been approved by FDA for congenital factor XIII deficiency, a rare condition affecting only 150 patients in the United States. The effectiveness of this product is based on maintaining a trough factor XIII activity level of approximately 5% to 20%. The drug has not been evaluated for the treatment of bleeding disorders in this patient population. The most common adverse events observed in clinical trials were hypersensitivity reactions, chills, elevations in temperature, arthralgia, headache, elevated thrombin–antithrombin levels, and increases in hepatic enzymes.