Factor XIII (human)

Identification

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Name
Factor XIII (human)
Accession Number
DB12909
Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Protein Based Therapies
Blood factors
Description

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.

Protein chemical formula
Not Available
Protein average weight
Not Available
Sequences
Not Available
Synonyms
  • Factor XIII
  • Factor XIII (fibrin stabilising factor)
  • Factor XIII concentrate (human)
  • factor XIII, human
  • Fibrinoligase
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
CorifactKit1600 [iU]/20mLIntravenousCSL Behring GmbH2011-02-17Not applicableUs
Corifact 1250Powder, for solutionIntravenousCsl Behring2014-04-03Not applicableCanada
Corifact 250Powder, for solutionIntravenousCsl Behring2014-04-03Not applicableCanada
TrettenKit2500 [iU]/3mLIntravenousNovo Nordisk2013-12-23Not applicableUs
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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International/Other Brands
Fibrogammin P
Categories
UNII
F7R0FBC1XD
CAS number
9013-56-3

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.

Associated Conditions
Pharmacodynamics
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.

Additional Data Available
Adverse Effects

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Additional Data Available
Contraindications

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Blackbox Warnings

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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

6.6 ±2.29 days Label 6.6 days 3

Clearance

0.25 ±0.09 mL/hr/kg Label 0.25 mL/hr/kg 3

Toxicity

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.

Affected organisms
Not Available
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.
DrugInteraction
(R)-warfarinThe therapeutic efficacy of Factor XIII (human) can be decreased when used in combination with (R)-warfarin.
(S)-WarfarinThe therapeutic efficacy of Factor XIII (human) can be decreased when used in combination with (S)-Warfarin.
4-hydroxycoumarinThe therapeutic efficacy of Factor XIII (human) can be decreased when used in combination with 4-hydroxycoumarin.
AbciximabThe therapeutic efficacy of Factor XIII (human) can be decreased when used in combination with Abciximab.
AcenocoumarolThe therapeutic efficacy of Factor XIII (human) can be decreased when used in combination with Acenocoumarol.
Acetylsalicylic acidThe therapeutic efficacy of Factor XIII (human) can be decreased when used in combination with Acetylsalicylic acid.
Alpha-1-proteinase inhibitorAlpha-1-proteinase inhibitor may increase the thrombogenic activities of Factor XIII (human).
AlteplaseThe therapeutic efficacy of Factor XIII (human) can be decreased when used in combination with Alteplase.
AmediplaseThe therapeutic efficacy of Factor XIII (human) can be decreased when used in combination with Amediplase.
Aminocaproic acidThe risk or severity of adverse effects can be increased when Aminocaproic acid is combined with Factor XIII (human).
Additional Data Available
  • Extended Description
    Extended Description

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    Severity

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Food Interactions
Not Available

References

General References
  1. 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. [PubMed:27019464]
  2. Hsieh L, Nugent D: Factor XIII deficiency. Haemophilia. 2008 Nov;14(6):1190-200. doi: 10.1111/j.1365-2516.2008.01857.x. [PubMed:19141159]
  3. 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. [PubMed:25458735]
External Links
PubChem Substance
347911406
RxList
RxList Drug Page
Drugs.com
Drugs.com Drug Page
Wikipedia
Factor_XIII
AHFS Codes
  • 20:28.16 — Hemostatics
FDA label
Download (289 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1CompletedTreatmentCongenital FXIII Deficiency / Congenital Hematological Disorder / Healthy Volunteers1
2RecruitingTreatmentSclerosis, Progressive Systemic1
2TerminatedTreatmentInflammatory Reaction / Ulcerative Colitis1
3CompletedNot AvailableCongenital factor XIII A-subunit deficiency2
3CompletedPreventionCongenital FXIII Deficiency / Congenital Hematological Disorder1
3CompletedTreatmentCongenital FXIII Deficiency / Congenital Hematological Disorder2
Not AvailableCompletedNot AvailableCongenital FXIII Deficiency / Congenital Hematological Disorder1
Not AvailableCompletedTreatmentCongenital factor XIII A-subunit deficiency / Hemophilia1
Not AvailableEnrolling by InvitationNot AvailableCongenital FXIII Deficiency / Congenital Hematological Disorder1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
KitIntravenous1600 [iU]/20mL
Powder, for solutionIntravenous
KitIntravenous2500 [iU]/3mL
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Taxonomy

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

Drug created on October 20, 2016 19:12 / Updated on December 12, 2019 07:27