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Corifact Generic Name & Formulations
Legal Class
Rx
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
Manufacturer
Generic Availability
NO
Corifact Indications
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
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
Not Applicable
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
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