References

  1. What Are Rare Clotting Factor Deficiencies? Montreal, QC: World Federation of Hemophilia; 2009.
  2. Hsieh L, Nugent D. Factor XIII Deficiency. Haemophilia. 2008;14:1190-1200. DOI: 10.1111/j.1365-2516.2008.01857.x
  3. Anwar R, Miloszewski K. Factor XIII Deficiency. British Journal of Haematology. 1999;107:468-484.
  4. Muszbek L, Adany R, Mikkola H. Novel Aspects of Blood Coagulation Factor XIII. I. Structure, Distribution, Activation, and Function. Critical Reviews in Clinical Laboratory Sciences. 1996;33(5):357-421.
  5. Data on file. Available from CSL Behring as COR DOF-001.
  6. Dardik R, Loscalzo J, Inbal A. Factor XIII (FXIII) and Angiogenesis. Journal of Thrombosis and Haemostasis. 2006;4:19-25.
  7. Nugent D. Prophylaxis in rare coagulation disorders — Factor XIII deficiency. Thrombosis Research. 2006; 118S1:S23–S28. doi:10.1016/j.thromres.2006.02.009
  8. Monroe DM, Hoffman, M. What does it take to make the perfect clot? Arterioscler Thromb Vasc Biol. 2006;26:41-48.
  9. Acharya S, Coughlin A, Dimichele D, et al. Rare Bleeding Disorder Registry: Deficiencies of Factors II, V, VII, X, XIII, fibrinogen, and dysfibrinogenemias. Journal of Thrombosis and Haemostasis. 2004;2:248-256.
  10. Aiyagari V, Testai F. Correction of coagulopathy in warfarin associated cerebral hemorrhage. Current Opinion in Critical Care. 2009;15:87-92.
  11. Pandey S, Vyas G. Adverse effects of plasma transfusion. Transfusion. 2012;52:65S-79S.
  12. Lovejoy A, Reynolds T, Visich J, et al. Safety and pharmacokinetics of recombinant factor XIII-A2 administration in patients with congenital factor XIII deficiency. Blood. 2006;108:57-62.
  13. MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders. National Hemophilia Foundation (NHF) Web site. http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx?menuid=57&contentid=693 . Accessed January 21, 2016.

Important Safety Information

Corifact®, FXIII Concentrate (Human), is indicated for routine prophylactic treatment and perioperative management of surgical bleeding in adult and pediatric patients with congenital Factor XIII deficiency. Corifact must be administered intravenously.

Corifact is contraindicated in individuals with known anaphylactic or severe systemic reactions to human plasma-derived products.

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.

Thromboembolic complications have been reported with Corifact; monitor patients with known risk factors for thrombotic events.

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.

The most common adverse reactions reported in clinical trials (frequency >1%) following treatment with Corifact were joint inflammation, hypersensitivity, rash, pruritus; hematoma, arthralgia, headache, elevated thrombin-anti-thrombin levels, and increased blood lactate dehydrogenase. Serious adverse reactions included hypersensitivity, acute ischemia, and neutralizing antibodies against FXIII.

Please see full prescribing information for Corifact, including patient product information.