Corifact (factor XIII)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Factor XIII (human) is a preparation of blood coagulation factor XIII derived from pooled human plasma.
Factor XIII (human) is a preparation of blood coagulation factor XIII derived from pooled human plasma. All plasma used in the manufacture of factor XIII (human) is obtained from US donors and is tested using serologic assays for hepatitis B surface antigen and antibodies to human immunodeficiency virus-1 (HIV-1), HIV-2, and hepatitis C virus (HCV). The plasma also is tested with nucleic acid testing for HCV, HIV-1, hepatitis A virus (HAV), hepatitis B virus (HBV), and parvovirus B19.
Factor XIII (human) is isolated from human plasma by ethanol precipitation and further purified using a series of viral inactivation/removal steps, including precipitation/adsorption, ion exchange chromatography, heat treatment (60degreesC for 10 hours in aqueous solution), and filtration.
Factor XIII circulates in plasma as a heterotetrameric glycoprotein consisting of 2 A-subunits and 2 B-subunits. Enzymatic activity resides in the A-subunits; the B-subunits function as carrier molecules for the A-subunits, stabilizing and protecting them from proteolysis.
Factor XIII is a proenzyme that is activated in the presence of calcium ions by thrombin cleavage of the A-subunit; upon activation, factor XIIIa promotes cross-linking of fibrin and other proteins, resulting in a fibrin clot that is more elastic and resistant to fibrinolysis. Factor XIIIa also cross-links alpha2-plasmin inhibitor to the alpha-chain of fibrin, resulting in protection of the fibrin clot from degradation by plasmin. Cross-linked fibrin is the end result of the coagulation cascade, and provides tensile strength to a primary hemostatic plug.
In a 12-week, open-label pharmacokinetic and safety study in 14 patients 5-42 years of age with congenital factor XIII deficiency, the mean increase in factor XIII activity levels after the third 40-unit/kg dose (i.e., at steady state) was 83% (range: 48-114%) compared with baseline. Mean half-life of the drug was approximately 6.6 days in these patients.
Generic name: factor XIII
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
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Indications
The following indications are listed for Corifact:
- Hereditary Factor Xiii Deficiency Disease
Also known as: Congenital Factor Xiii Deficiency.
Dosing
Dosage of factor XIII (human) is expressed in international units (IU, units) of factor XIII activity. Each vial contains 1000-1600 units of factor XIII (human); the actual number of units of factor XIII activity is indicated on each vial label and carton.
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
Formal drug interaction studies with factor XIII (human) have not been performed to date.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
Factor XIII (human) is contraindicated in patients with known anaphylactic or severe systemic reactions to human plasma-derived products.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Adverse effects reported in more than 1% of patients receiving factor XIII (human) in clinical trials included joint inflammation, hypersensitivity reactions (i.e., rash, pruritus, erythema), hematoma, arthralgia, headache, elevated thrombin-antithrombin levels, and increased blood lactate dehydrogenase.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Of the 188 patients in the factor XIII (human) clinical studies, 108 were younger than 16 years of age at the time of enrollment (including 18 patients younger than 2 years of age). In a pharmacokinetic study, 5 of the 14 patients ranged in age from 2 to younger than 16 years of age. Patients younger than 16 years of age had a shorter mean half-life (5.7 days) and faster mean clearance (0.29 mL/hour per kg) compared with adults (half-life: 7.1 days, clearance: 0.22 mL/hour per kg); dosage adjustments may be necessary in this pediatric age group. There were no apparent differences in the safety profile of factor XIII (human) in children compared with adults.
Category C. (See Users Guide.) Although safety and efficacy of factor XIII (human) have not been established in pregnant women, the drug has been used throughout pregnancy in some women with congenital factor XIII deficiency to prevent spontaneous abortion and obstetrical bleeding complications.
Safety and efficacy of factor XIII (human) in labor and delivery have not been established.
It is not known whether factor XIII (human) is distributed into human milk. Because many drugs are distributed into milk, the drug should be used with caution in nursing women.
The safety and efficacy of factor XIII (human) in geriatric patients have not been established.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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