Important Safety Information
Corifact is indicated for routine prophylactic treatment of congenital Factor XIII deficiency. The effectiveness of Corifact is based on a maintained trough FXIII level of approximately 5% to 20%. There are no controlled studies demonstrating a direct benefit on treatment of bleeding episodes with Corifact. Corifact must be administered intravenously.
Corifact is contraindicated in individuals with known anaphylactic or severe systemic reactions to human plasma-derived products or to any component of Corifact or its components.
Hypersensitivity reactions may occur with Corifact. If there are signs of anaphylaxis or hypersensitivity reactions (including urticaria, rash, tightness of the chest, wheezing, and hypotension), immediately discontinue administration and institute appropriate treatment.
Inhibitory antibodies to FXIII have been detected in patients receiving Corifact. Monitor the patient's trough FXIII activity level during treatment. If expected plasma FXIII activity levels are not attained or breakthrough bleeding occurs, perform an assay measuring FXIII inhibitory antibody concentrations.
Thrombotic events have been reported with Corifact. Weigh the benefits of administration versus the risks of thrombosis, particularly in pregnant women, who are at increased risk.
Corifact is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
In clinical trials, the most common adverse reactions reported in more than one subject (frequency >1%) following treatment with Corifact were hypersensitivity reactions (including allergy, rash, pruritus, and erythema), chills/rise in temperature, arthralgia, headache, elevated thrombin-antithrombin levels, and an increase in hepatic enzymes.
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