Identification
- Summary
Factor XIII (human) is a purified form of Factor XIII that is used to prevent and treat surgical bleeding in patients with a Factor XIII deficiency.
- Brand Names
- Corifact
- Generic Name
- Factor XIII (human)
- DrugBank Accession Number
- DB12909
- Background
Factor XIII (human) is a heat-treated, lyophilized concentrate of coagulation factor XIII, an endogenous enzyme responsible for the crosslinking of fibrin and an essential component of the coagulation cascade Label. For people with congenital deficiency or mutation of Factor XIII, a rare bleeding disorder, exogenous replacement of this key coagulation factor is essential for management and prevention of bleeding episodes.
Also known as Fibrin Stabilizing Factor (FSF), Factor XIII is an endogenously produced coagulation factor and the final enzyme within the blood coagulation cascade. Within the body, FXIII circulates as a heterotetramer composed of 2 A-subunits and 2 B-subunits (A2B2)2. When activated by thrombin at the site of injury, the FXIII pro-enzyme is cleaved resulting in activation of the catalytic A-subunit and dissociation from its carrier B-subunit. As a result, the active transglutaminase from subunit A cross-links fibrin and other proteins resulting in increased mechanical strength and resistance to fibrinolysis of the fibrin clot. This contributes to enhanced platelet and clot adhesion to injured tissue, thereby improving blood coagulation and maintenance of hemostasis 1.
Other drug products with similar structure and function to Factor XIII (human) include Catridecacog, which is a recombinant form of the A subunit of human coagulation factor XIII. Compared to Factor XIII (human), which is purified from pooled human plasma, Catridecacog is produced through recombinant DNA technology where the target protein is grown in yeast and then isolated Label.
Factor XIII (Human), available as the commercially available product Corifact, is approved by the Food and Drug Administration for routine prophylactic treatment and peri-operative management of surgical bleeding in adult and pediatric patients with congenital FXIII deficiency Label. As the half-life of endogenous Factor XIII is long (5-11 days), prophylactic therapy with the replacement of FXIII can be given every 4-6 to maintain hemostasis2.
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Protein Based Therapies
Blood factors - Protein Chemical Formula
- Not Available
- Protein Average Weight
- Not Available
- Sequences
- Not Available
- Synonyms
- Coagulation factor XIII, recombinant
- Factor XIII
- Factor XIII (fibrin stabilising factor)
- Factor XIII concentrate (human)
- Factor XIII, human
- Fibrinoligase
- Human coagulation factor XIII
Pharmacology
- Indication
Factor XIII (Human), available as the commercially available product Corifact, is approved by the Food and Drug Administration for routine prophylactic treatment and peri-operative management of surgical bleeding in adult and pediatric patients with congenital FXIII deficiency Label.
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- Contraindications & Blackbox Warnings
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Not Available
- Mechanism of action
Also known as Fibrin Stabilizing Factor (FSF), Factor XIII is an endogenously produced coagulation factor and the final enzyme within the blood coagulation cascade. Within the body, FXIII circulates as a heterotetramer composed of 2 A-subunits and 2 B-subunits (A2B2)2. When activated by thrombin at the site of injury, the FXIII pro-enzyme is cleaved resulting in activation of the catalytic A-subunit and dissociation from its carrier B-subunit. As a result, the active transglutaminase from subunit A cross-links fibrin and other proteins resulting in increased mechanical strength and resistance to fibrinolysis of the fibrin clot. This contributes to enhanced platelet and clot adhesion to injured tissue, thereby improving blood coagulation and maintenance of hemostasis 1. Exogenous replacement of Factor XIII is a cornerstone of treatment for bleeding associated with congenital Factor XIII deficiency.
- Absorption
Tmax = 1.7 ±1.44 hr Label Tmax = 1.72 hr 3
Cmax = 0.9 ±0.20 units/mL (peak concentration at steady state) Label Cmax = 87.7% (peak concentration at steady state) 3
- Volume of distribution
Vss = 51.1 mL/kg (volume of distribution at steady state) 3
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Not Available
- Half-life
- Clearance
- Adverse Effects
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Corifact was studied in an acute toxicity study in mice and rats at doses up to 3550 units per kg and 1420 units per kg, respectively. Repeat dose toxicity was studied in rats at daily doses up to 350 units per kg for a period of 14 days. No signs of toxicity were observed in the single dose and repeat dose studies.
A local tolerance study in rabbits demonstrated no clinical or histopathological changes at the injection site after intravenous, intra-arterial or para-venous administration of Corifact.
A thrombogenicity test was performed in rabbits at doses up to 350 units per kg. Corifact showed no thrombogenic potential at the doses tested.
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction Integrate drug-drug
interactions in your softwareAbciximab The therapeutic efficacy of Factor XIII (human) can be decreased when used in combination with Abciximab. Acenocoumarol The therapeutic efficacy of Factor XIII (human) can be decreased when used in combination with Acenocoumarol. Alpha-1-proteinase inhibitor Alpha-1-proteinase inhibitor may increase the thrombogenic activities of Factor XIII (human). Alteplase The therapeutic efficacy of Factor XIII (human) can be decreased when used in combination with Alteplase. Aminocaproic acid The risk or severity of adverse effects can be increased when Aminocaproic acid is combined with Factor XIII (human). Ancrod The therapeutic efficacy of Factor XIII (human) can be decreased when used in combination with Ancrod. Anistreplase The therapeutic efficacy of Factor XIII (human) can be decreased when used in combination with Anistreplase. Antithrombin Alfa The therapeutic efficacy of Factor XIII (human) can be decreased when used in combination with Antithrombin Alfa. Antithrombin III human The therapeutic efficacy of Factor XIII (human) can be decreased when used in combination with Antithrombin III human. Apixaban The therapeutic efficacy of Factor XIII (human) can be decreased when used in combination with Apixaban. 
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- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- International/Other Brands
- Fibrogammin P
- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Corifact Solution 1600 [iU]/20mL Intravenous CSL Behring GmbH 2011-02-17 Not applicable US 
Corifact 1250 Powder, for solution 1250 unit Intravenous Csl Behring 2014-04-03 Not applicable Canada 
Corifact 250 Powder, for solution 250 unit Intravenous Csl Behring 2014-04-03 Not applicable Canada
Categories
- Drug Categories
- Acyltransferases
- Amino Acids, Peptides, and Proteins
- Aminoacyltransferases
- Biological Factors
- Blood Coagulation Factors
- Blood Proteins
- Enzyme Precursors
- Enzymes
- Enzymes and Coenzymes
- Factor XIIIa, antagonists & inhibitors
- Hemostatics
- Increased Coagulation Activity
- Increased Fibrin Polymerization Activity
- Protein Precursors
- Proteins
- Transferases
- Transglutaminases
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Not Available
Chemical Identifiers
- UNII
- F7R0FBC1XD
- CAS number
- 9013-56-3
References
- General References
- Schroeder V, Kohler HP: Factor XIII: Structure and Function. Semin Thromb Hemost. 2016 Jun;42(4):422-8. doi: 10.1055/s-0036-1571341. Epub 2016 Mar 28. [Article]
- Hsieh L, Nugent D: Factor XIII deficiency. Haemophilia. 2008 Nov;14(6):1190-200. doi: 10.1111/j.1365-2516.2008.01857.x. [Article]
- Nugent DJ, Ashley C, Garcia-Talavera J, Lo LC, Mehdi AS, Mangione A: Pharmacokinetics and safety of plasma-derived factor XIII concentrate (human) in patients with congenital factor XIII deficiency. Haemophilia. 2015 Jan;21(1):95-101. doi: 10.1111/hae.12505. Epub 2014 Dec 2. [Article]
- External Links
- PubChem Substance
- 347911406
- 4271
- RxList
- RxList Drug Page
- Drugs.com
- Drugs.com Drug Page
- Wikipedia
- Factor_XIII
- FDA label
- Download (289 KB)
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 3 Completed Not Available Factor XIII Deficiency 2 3 Completed Prevention Congenital FXIII Deficiency / Congenital Hematological Disorder 1 3 Completed Treatment Congenital FXIII Deficiency / Congenital Hematological Disorder 2 2 Terminated Treatment Inflammation / Ulcerative Colitis 1 2 Unknown Status Treatment Systemic Sclerosis (SSc) 1 1 Completed Treatment Congenital FXIII Deficiency / Congenital Hematological Disorder / Healthy Subjects (HS) 1 Not Available Active Not Recruiting Not Available Gastrointestinal Hemorrhage 1 Not Available Completed Not Available Congenital FXIII Deficiency / Congenital Hematological Disorder 1 Not Available Completed Treatment Factor XIII Deficiency / Hemophilia 1 Not Available Enrolling by Invitation Not Available Congenital FXIII Deficiency / Congenital Hematological Disorder 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, powder, for solution Parenteral 1250 U.I. Injection, powder, for solution Parenteral 250 U.I. Solution Intravenous 1600 [iU]/20mL Powder, for solution Intravenous 1250 unit Powder, for solution Intravenous 250 unit Injection, powder, for solution Parenteral - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Not Available
- Experimental Properties
- Not Available
Drug created at October 21, 2016 01:12 / Updated at July 02, 2022 14:09