• Bleeding disorders

Corifact Generic Name & Formulations

General Description

Factor XIII concentrate (human); 1000–1600 units; per vial; powder for IV injection after reconstitution; preservative-free.

Pharmacological Class

Clotting factor.

How Supplied

Single-use vial—1


Generic Availability


Corifact Indications


Routine prophylactic treatment and peri-operative management of surgical bleeding in patients with congenital Factor XIII (FXIII) deficiency.

Corifact Dosage and Administration

Adults and Children

Give by slow IV injection at a rate of ≤4mL/min. Initially 40units/kg. Adjust ±5units/kg to maintain 5–20% trough FXIII activity levels using Berichrom Activity Assay: One trough level of <5%: increase by 5units/kg; trough level of 5–20%: no change; two trough levels of >20%: decrease by 5units/kg; one trough level of >25%: decrease by 5units/kg. Routine prophylaxis: give every 28 days. Peri-operative management: individualized based on patient's FXIII activity level, surgery type, and clinical response; dose adjustment: see full labeling.

Corifact Contraindications

Not Applicable

Corifact Boxed Warnings

Not Applicable

Corifact Warnings/Precautions


Contains human plasma; monitor for possible infection transmission. Long-term therapy: consider appropriate vaccination (hepatitis A and B virus). Monitor FXIII activity levels during and after surgery. Monitor for development of inhibitory antibodies, thromboembolic events. Pregnancy (Cat. C). Nursing mothers.

Corifact Pharmacokinetics

See Literature

Corifact Interactions

Corifact Adverse Reactions

Adverse Reactions

Joint inflammation, hypersensitivity, rash, pruritus, erythema, hematoma, arthralgia, headache, elevated thrombin-antithrombin levels, increased blood lactate dehydrogenase; acute ischemia, neutralizing antibodies.

Corifact Clinical Trials

See Literature

Corifact Note

Not Applicable

Corifact Patient Counseling

See Literature