CORIFACT – Effective Prophylactic and Perioperative Treatment for Patients With FXIII Deficiency

CORIFACT effectively maintains FXIII levels, whether administered prophylactically every 28 days or perioperatively.

Effective prophylactic treatment for patients with FXIII deficiency.

In a 12-month, prospective, open-label, multicenter efficacy and safety study of 41 subjects, CORIFACT demonstrated:
- An annualized bleeding rate of 0 episodes per subject/year during routine prophylactic treatment compared to a historical annualized bleeding rate of 2.5 episodes per subject/year for on-demand treatment
- No spontaneous bleeding episodes serious enough to require FXIII treatment occurred during the study

Effective control of perioperative bleeding for patients with FXIII deficiency

Of the 4 subjects who received CORIFACT prior to surgery, 75% had no postoperative bleeding.¹⁵

CORIFACT Delivers a Consistent Amount of FXIII

Pharmacokinetic parameters by Berichrom^® assay method^a,b

PARAMETERS (N=13)	MEAN ± SD
C_{ss, max} (units/mL)	0.9 ± 0.20
C_{ss, min} (units/mL)	0.05 ± 0.05
T_max(hr)	1.7 ± 1.44
Half-life (days)	6.6 ± 2.29
MRT (days)	10.0 ± 3.45

C_{ss, max} = peak concentration at steady state
C_{ss, min} = trough concentration at steady state
T_max = time to peak concentration
SD = standard deviation
Units = international units

^aValues in the table are based on the Berichrom^® activity assay for FXIII. If other assays are used to determine FXIII levels, results may vary, and dosing adjustments must be based on the specific assay capabilities as determined by the physician.
^bBaseline adjusted values

CORIFACT effectively maintains FXIII levels

The prophylactic administration of CORIFACT dosed at 40 IU/kg every 28 days achieved mean FXIII activity levels between 5% and 20%.
Most subjects (≥85%) maintained FXIII activity ≥10%.
Of the 533 doses administered to 41 subjects, dose adjustments were required on only 8 occasions, supporting a dose of 40 IU/kg every 28 days.

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.