Catridecacog

Identification

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Name
Catridecacog
Accession Number
DB09310
Type
Biotech
Groups
Approved
Biologic Classification
Protein Based Therapies
Blood factors
Description

Coagulation Factor XIII A-Subunit (Recombinant), also known as catridecacog, is a recombinant form of the Factor XIII-A2 homodimer composed of two factor XIII (FXIII) A-subunits 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 available coagulation factor and the final enzyme within the blood coagulation cascade. Within the body, FXIII circulates as a heterotetramer composed of 2 catalytic A-subunits and 2 non-catalytic B-subunits (FXIII-A2B2) 4. When activated by thrombin at the site of injury, the FXIII A2B2 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 2.

When supplied as the recombinant form, Coagulation Factor XIII A-Subunit (Recombinant) binds to free human FXIII B-subunit resulting in a heterotetramer (rA2B2) with a similar activity profile and half-life as the endogenously available form. In patients with congenital factor XIII A-subunit deficiency, this product (marketed as Tretten) is indicated for the routine prophylaxis of bleeding. In these patients, activated rFXIII has been shown to increase the mechanical strength of fibrin clots, slow down fibrinolysis, and to enhance platelet adhesion to the site of injury. 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 hemostasis4.

Other drug products with similar structure and function to Coagulation Factor XIII A-Subunit (Recombinant) include Factor XIII (human), which is a purified endogenous (human) form of coagulation factor XIII. Compared to Coagulation Factor XIII A-Subunit (Recombinant), which is produced through recombinant DNA technology where the target protein is grown in yeast and then isolated, the human form is isolated from pooled human plasma.

Coagulation Factor XIII A-Subunit (Recombinant) is available in the US as the commmercially available product Tretten, and in the EU as NovoThirteen. Tretten is manufactured as an intracellular, soluble protein in yeast (Saccharomyces cerevisiae) production strain containing the episomal expression vector, pD16. It is subsequently isolated by homogenization of cells and purification by several chromatography steps, including hydrophobic interaction and ion exchange chromatography Label.

Protein structure
Db09310
Protein chemical formula
Not Available
Protein average weight
Not Available
Sequences
>Coagulation Factor XIII A-Subunit (dimer)
MSETSRTAFGGRRAVPPNNSNAAEDDLPTVELQGVVPRGVNLQEFLNVTSVHLFKERWDT
NKVDHHTDKYENNKLIVRRGQSFYVQIDFSRPYDPRRDLFRVEYVIGRYPQENKGTYIPV
PIVSELQSGKWGAKIVMREDRSVRLSIQSSPKCIVGKFRMYVAVWTPYGVLRTSRNPETD
TYILFNPWCEDDAVYLDNEKEREEYVLNDIGVIFYGEVNDIKTRSWSYGQFEDGILDTCL
YVMDRAQMDLSGRGNPIKVSRVGSAMVNAKDDEGVLVGSWDNIYAYGVPPSAWTGSVDIL
LEYRSSENPVRYGQCWVFAGVFNTFLRCLGIPARIVTNYFSAHDNDANLQMDIFLEEDGN
VNSKLTKDSVWNYHCWNEAWMTRPDLPVGFGGWQAVDSTPQENSDGMYRCGPASVQAIKH
GHVCFQFDAPFVFAEVNSDLIYITAKKDGTHVVENVDATHIGKLIVTKQIGGDGMMDITD
TYKFQEGQEEERLALETALMYGAKKPLNTEGVMKSRSNVDMDFEVENAVLGKDFKLSITF
RNNSHNRYTITAYLSANITFYTGVPKAEFKKETFDVTLEPLSFKKEAVLIQAGEYMGQLL
EQASLHFFVTARINETRDVLAKQKSTVLTIPEIIIKVRGTQVVGSDMTVTVEFTNPLKET
LRNVWVHLDGPGVTRPMKKMFREIRPNSTVQWEEVCRPWVSGHRKLIASMSSDSLRHVYG
ELDVQIQRRPSM
Download FASTA Format
Synonyms
  • Blood Coagulation Factor XIII (Synthetic Human A-Chain Precursor)
  • Catridecacog
  • Coagulation Factor XIII A-Subunit (recombinant)
  • Factor XIII A-Subunit (Recombinant)
  • Human Factor XIII (A2) homodimer (allele F13A*1B), recombinant DNA origin
  • Recombinant Coagulation Factor XIII
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
NovothirteenInjection, powder, for solution2500 IUIntravenousNovo Nordisk2012-09-03Not applicableEu
TrettenPowder, for solution2500 unitIntravenousNovo Nordisk2013-01-30Not applicableCanada
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

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Categories
UNII
NU23Q531G1
CAS number
606138-08-3

Pharmacology

Indication

For routine prophylaxis of bleeding in patients with congenital factor XIII A-Subunit deficiency.

Associated Conditions
Pharmacodynamics
Not Available
Mechanism of action
TargetActionsOrganism
ACoagulation factor XIII B chainNot AvailableHumans
Additional Data Available
Adverse Effects

Comprehensive structured data on known drug adverse effects with statistical prevalence. MedDRA and ICD10 ids are provided for adverse effect conditions and symptoms.

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Additional Data Available
Contraindications

Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

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Additional Data Available
Blackbox Warnings

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Absorption

Following intravenous administration, the maximum concentration (Cmax) was found to be 0.48 IU/mL Label.

Volume of distribution
Not Available
Protein binding
Not Available
Metabolism
Not Available
Route of elimination
Not Available
Half life

7.1 days

Clearance

0.41 mL/h/kg

Toxicity

The most common adverse reactions reported in clinical trials (≥1%), were headache, pain in the extremities, injection site pain, and increase in fibrin D dimer levels. Due to the anti-clotting activity of this medication, thromboembolic complications may occur with its usage.

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 Catridecacog can be decreased when used in combination with (R)-warfarin.
(S)-WarfarinThe therapeutic efficacy of Catridecacog can be decreased when used in combination with (S)-Warfarin.
4-hydroxycoumarinThe therapeutic efficacy of Catridecacog can be decreased when used in combination with 4-hydroxycoumarin.
AbciximabThe therapeutic efficacy of Catridecacog can be decreased when used in combination with Abciximab.
AcenocoumarolThe therapeutic efficacy of Catridecacog can be decreased when used in combination with Acenocoumarol.
Acetylsalicylic acidThe therapeutic efficacy of Catridecacog can be decreased when used in combination with Acetylsalicylic acid.
Alpha-1-proteinase inhibitorAlpha-1-proteinase inhibitor may increase the thrombogenic activities of Catridecacog.
AlteplaseThe therapeutic efficacy of Catridecacog can be decreased when used in combination with Alteplase.
AmediplaseThe therapeutic efficacy of Catridecacog 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 Catridecacog.
Additional Data Available
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    Extended Description

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  • Severity
    Severity

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    Action

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Food Interactions
Not Available

References

General References
  1. Korte W: Catridecacog: a breakthrough in the treatment of congenital factor XIII A-subunit deficiency? J Blood Med. 2014 Jul 9;5:107-13. doi: 10.2147/JBM.S35395. eCollection 2014. [PubMed:25031548]
  2. 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]
  3. Inbal A, Oldenburg J, Carcao M, Rosholm A, Tehranchi R, Nugent D: Recombinant factor XIII: a safe and novel treatment for congenital factor XIII deficiency. Blood. 2012 May 31;119(22):5111-7. doi: 10.1182/blood-2011-10-386045. Epub 2012 Mar 26. [PubMed:22451421]
  4. 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]
External Links
KEGG Drug
D10532
PubChem Substance
347910434
ChEMBL
CHEMBL2108282
RxList
RxList Drug Page
Drugs.com
Drugs.com Drug Page
Wikipedia
Catridecacog
ATC Codes
B02BD11 — Catridecacog
AHFS Codes
  • 20:28.16 — Hemostatics
FDA label
Download (220 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1CompletedTreatmentAcquired Bleeding Disorder / Cardiac Surgery Requiring Cardiopulmonary Bypass1
1CompletedTreatmentAcquired Bleeding Disorder / Cardiac Surgery Requiring Cardiopulmonary Bypass / Healthy Volunteers1
1CompletedTreatmentCongenital FXIII Deficiency / Congenital Hematological Disorder1
1CompletedTreatmentCongenital FXIII Deficiency / Congenital Hematological Disorder / Healthy Volunteers3
2CompletedPreventionAcquired Bleeding Disorder / Cardiac Surgery Requiring Cardiopulmonary Bypass1
2TerminatedTreatmentInflammatory Reaction / Ulcerative Colitis1
3CompletedPreventionCongenital FXIII Deficiency / Congenital Hematological Disorder2
3CompletedTreatmentCongenital FXIII Deficiency / Congenital Hematological Disorder2
Not AvailableCompletedNot AvailableCongenital FXIII Deficiency / Congenital Hematological Disorder1
Not AvailableEnrolling by InvitationNot AvailableCongenital FXIII Deficiency / Congenital Hematological Disorder1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
Injection, powder, for solutionIntravenous2500 IU
Powder, for solutionIntravenous2500 unit
Prices
Not Available
Patents
Not Available

Properties

State
Solid
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

Targets

Kind
Protein
Organism
Humans
Pharmacological action
Yes
General Function
The B chain of factor XIII is not catalytically active, but is thought to stabilize the A subunits and regulate the rate of transglutaminase formation by thrombin.
Specific Function
Not Available
Gene Name
F13B
Uniprot ID
P05160
Uniprot Name
Coagulation factor XIII B chain
Molecular Weight
75510.1 Da

Drug created on November 13, 2015 12:08 / Updated on December 08, 2019 20:10