CORIFACT – Safe for Prophylactic and Perioperative Use

CORIFACT has been studied in 12 clinical studies that included a total of 188 subjects.

CORIFACT has been studied in both adult and pediatric populations:

  • 57% (108 subjects) of all patients were <16 years of age.
  • There were no differences in the safety profile in children compared with adults.

In a 12-month postmarketing study in 41 patients, there were no reports of deaths, life-threatening events, or adverse events that led to discontinuation or withdrawal.

  • No clinically meaningful treatment-related adverse events were reported.a
  • The most common adverse reactions reported in clinical trials (frequency >1%) following treatment with CORIFACT were joint inflammation, hypersensitivity, rash, pruritus, erythema, hematoma, arthralgia, headache, elevated thrombin-antithrombin levels, and increased blood lactate dehydrogenase. The serious adverse reactions, reported in one subject each (frequency 0.5%), were hypersensitivity, acute ischemia, and neutralizing antibodies against FXIII.
aOne subject was pretreated with plasma and experienced a hypersensitivity reaction.

Virus Inactivation

CORIFACT is a heat-treated, lyophilized powder of coagulation FXIII for reconstitution for intravenous use.

CORIFACT is made from pooled human plasma and thus may carry a risk of transmitting infectious agents. However, virus inactivation and removal steps in the CORIFACT manufacturing process reduce the risk of exposure to infectious agents. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Overall Virus Inactivations/Removal in CORIFACT

Manufacturing Steps Virus Reduction Factor (log10)
Enveloped Viruses Non-Enveloped Viruses
  HIV BVDV WNV PRV HAV CPV
AI(OH)3 Adsorption / Vitacel® and Defibrination n.d. n.d. n.d. 6.9 n.d. n.d.
Ion Exchange Chromatography 5.0 3.3 n.d. ≥8.0 3.4 3.7
Heat Treament ≥7.7 ≥8.1 ≥7.4 N/A* 4.3 1.0†
20 nm / 20 nm Virus Filtration ≥6.1 ≥5.0 ≥7.4 ≥6.4 ≥5.6 6.1
Cumulative Virus Reduction (log10) ≥18.8 ≥16.4 ≥14.8 ≥21.3 ≥13.3 10.8

HIV, Human immunodeficiency virus type 1, model for HIV-1 and HIV-2
BVDV, bovine viral diarrhea virus, model for HCV
WNV, West Nile virus
PRV, pseudorabies virus, a model for large enveloped DNA viruses
HAV, Hepatitis A virus
CPV, canine parvovirus, model for B19V
B19V, Human parvovirus B19
N/A, not applicable
n.d., not done

* Not included in the calculation of the overall virus reduction factor.
† Studies using human parvovirus B19, which are considered experimental in nature, have demonstrated a virus reduction factor of ≥4.0 log10 by heat treatment.

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 www.fda.gov/medwatch.