Tretten (factor XIII A-subunit, recombinant)
Factor XIII Intravenous Vial (EA)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Factor XIII A-subunit (recombinant) is a biosynthetic (recombinant DNA origin) preparation of human factor XIII A2 homodimer consisting of 2 factor XIII A-subunits.
Factor XIII A-subunit (recombinant) is a biosynthetic (recombinant DNA origin) preparation of human factor XIII A2 homodimer consisting of 2 factor XIII A-subunits. The factor XIII A-subunit is the active catalytic domain of the factor XIII molecule.
Factor XIII is a proenzyme (protransglutaminase) that serves an essential role in the final stages of the blood coagulation cascade. When activated by thrombin in the presence of calcium, activated factor XIII (factor XIIIa) promotes cross-linking of fibrin and other proteins (alpha2-plasmin inhibitor, fibrinogen, collagen) to strengthen and stabilize the fibrin clot, protect it from fibrinolysis, and enhance platelet and clot adhesion to the site of tissue injury. Patients with congenital factor XIII A-subunit deficiency have decreased plasma levels of endogenous factor XIII A-subunit, resulting in a hemorrhagic tendency.
Factor XIII A-subunit (recombinant) restores normal clot solubility in such patients.
Factor XIII circulates in plasma as a heterotetrameric glycoprotein consisting of 2 A-subunits and 2 B-subunits (A2B2). Enzymatic activity resides in the A-subunits; the B-subunits function as carrier molecules, stabilizing and protecting the A-subunits from proteolysis. Approximately 50% of endogenous factor XIII B-subunit is present in a free, noncomplexed form.
Factor XIII A-subunit (recombinant) binds to free factor XIII B-subunit to form the factor XIII A2B2 tetramer. In its complexed form, factor XIII A-subunit (recombinant) displays pharmacodynamic and pharmacokinetic (e.g., half-life) properties similar to those of endogenous factor XIII. After IV administration of factor XIII A-subunit (recombinant), factor XIII activity increases in a dose-dependent manner; plasma concentrations of factor XIII A-subunit and factor XIII A2B2 tetramer also increase.
Administration of 35 units/kg of factor XIII A-subunit (recombinant) increases plasma factor XIII activity to adequate levels and restores normal clot solubility for approximately 28-30 days. Half-life of the drug ranges from 5-15 days depending on patient age, sampling time, specific assay used, and other factors.
Factor XIII A-subunit (recombinant) is prepared using DNA technology in a yeast (Saccharomyces cerevisiae) expression system and further purified with a series of chromatography steps, including hydrophobic interaction and ion exchange chromatography. The drug is manufactured without any human or animal components.
Generic name: factor XIII A-subunit, recombinant
Drug class: Factor XIII
Therapeutic class: Hematological Agents
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Tretten
Indications
The following indications are listed for Tretten:
- Hereditary Factor Xiii A Subunit Deficiency
Also known as: Congenital Factor Xiii A Subunit Deficiency, Congenital Factor Xiii Alpha Subunit Deficiency, Hereditary Factor Xiii Alpha Subunit Deficiency.
Dosing
Dosage of factor XIII A-subunit (recombinant) is expressed in international units (IU, units). Each vial of lyophilized drug contains 2000-3125 units of factor XIII A-subunit (recombinant); the actual number of units contained in each vial is indicated on the vial label and carton. After reconstitution with the supplied sterile water for injection, each vial contains 667-1042 units/mL of factor XIII A-subunit (recombinant).
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No dosing information is available for this tab.
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Drug interactions
Concomitant use of factor VIIa (recombinant) may increase the risk of thrombosis in patients receiving factor XIII A-subunit (recombinant). (See Thromboembolic Complications under Cautions: Warnings/Precautions.)
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
Known hypersensitivity reactions to factor XIII A-subunit (recombinant) or any components of the preparation.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- Thromboembolic disorder
Adverse reactions
Adverse effects observed in at least 1% of patients receiving factor XIII A-subunit (recombinant) in clinical trials were headache, extremity pain, injection site pain, and increased fibrin D dimer levels.
Less Frequent
- Thromboembolic disorder
Rare or Very Rare
- Acute myocardial infarction
- Anaphylaxis
- Thrombotic disorder
Less Frequent
- Arthralgia
- Arthritis
- Erythema
- Headache disorder
- Hematoma
- Pruritus of skin
Rare or Very Rare
- Chills
Precautions
No enhanced messaging available.
Pediatric patients ranging in age from 0-17 have received factor XIII A-subunit (recombinant) for prophylactic treatment of congenital factor XIII A-subunit deficiency in clinical studies. Adverse effects, including those possibly or probably related to the study drug, were reported more frequently in children 6 to younger than 18 years of age compared with adults. These effects included the development of non-neutralizing antibodies. (See Immunogenicity under Cautions: Warnings/Precautions.)
Pharmacokinetics (e.g., peak plasma concentrations, half-life, trough factor XIII levels) of factor XIII A-subunit (recombinant) appear to be similar among different age groups, including pediatric patients; dosage adjustments based on age are not required.
Category C. (See Users Guide.)
It is not known whether factor XIII A-subunit (recombinant) is distributed into human milk. Because many drugs are distributed into milk, the drug should be used with caution in nursing women.
Safety and efficacy of factor XIII A-subunit (recombinant) in geriatric patients have not been established.
ICD codes
| Code | Type | Description |
|---|---|---|
| Hereditary factor XIII a subunit deficiency | ||
| D68.2 | ICD10CM | Hereditary deficiency of other clotting factors |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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