Treatment of FXIII Deficiency

Prophylactic therapy is the management strategy of choice for most patients with FXIII deficiency, particularly those with a history of intracranial hemorrhage (ICH).2

Traditional treatment options have serious limitations

  • Fresh frozen plasma (FFP) and cryoprecipitate (cryo):
    • Do not undergo virus inactivation or removal processes, increasing risk of exposure to infectious agents7
    • Contain additional proteins, which may increase risk of allergic reactions or adverse events9
    • Require thawing and compatability testing before use, prolonging time before infusion10
    • Have potential for fluid overload because high volumes are needed to supply enough Factor XIII11
    • May introduce risk of transfusion-related acute lung injury (TRALI), which is a leading cause of transfusion-related mortality11
  • Other replacement therapies:
    • Although either A- or B-subunits can be affected, some replacement products may not contain these dual subunits.12

The Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation (NHF) recommends FXIII concentrate for the treatment of patients with FXIII deficiency.13

CORIFACT is the first and only dual-subunit FXIII concentrate

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 blood. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), 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.

To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or