Catridecacog
Identification
- Summary
Catridecacog is a recombinant FXIII subunit‐A molecule evaluated for clotting factor replacement therapy in congenital FXIII deficiency.
- Brand Names
- Novothirteen, Tretten
- Generic Name
- Catridecacog
- DrugBank Accession Number
- DB09310
- Background
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.
- Type
- Biotech
- Groups
- Approved
- Biologic Classification
- Protein Based Therapies
Blood factors - Protein Structure
- 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
Pharmacology
- Indication
For routine prophylaxis of bleeding in patients with congenital factor XIII A-Subunit deficiency.
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- Contraindications & Blackbox Warnings
- Avoid life-threatening adverse drug eventsImprove clinical decision support with information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events & improve clinical decision support.
- Pharmacodynamics
Not Available
- Mechanism of action
Target Actions Organism ACoagulation factor XIII B chain Not Available Humans - 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
- Adverse Effects
- Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates.Improve decision support & research outcomes with our structured adverse effects data.
- 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.
- 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 Catridecacog can be decreased when used in combination with Abciximab. Acenocoumarol The therapeutic efficacy of Catridecacog can be decreased when used in combination with Acenocoumarol. Alpha-1-proteinase inhibitor Alpha-1-proteinase inhibitor may increase the thrombogenic activities of Catridecacog. Alteplase The therapeutic efficacy of Catridecacog 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 Catridecacog. Ancrod The therapeutic efficacy of Catridecacog can be decreased when used in combination with Ancrod. Anistreplase The therapeutic efficacy of Catridecacog can be decreased when used in combination with Anistreplase. Antithrombin Alfa The therapeutic efficacy of Catridecacog can be decreased when used in combination with Antithrombin Alfa. Antithrombin III human The therapeutic efficacy of Catridecacog can be decreased when used in combination with Antithrombin III human. Apixaban The therapeutic efficacy of Catridecacog can be decreased when used in combination with Apixaban. Identify potential medication risksEasily compare up to 40 drugs with our drug interaction checker.Get severity rating, description, and management advice.Learn more - Food Interactions
- 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.
- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Novothirteen Injection, powder, for solution 2500 IU Intravenous Novo Nordisk 2016-09-08 Not applicable EU Tretten Powder, for solution 2500 unit / vial Intravenous Novo Nordisk 2013-01-30 Not applicable Canada Tretten Kit 2500 [iU]/3mL Intravenous Novo Nordisk 2013-12-23 Not applicable US
Categories
- ATC Codes
- B02BD11 — Catridecacog
- Drug Categories
- 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
- NU23Q531G1
- CAS number
- 606138-08-3
References
- General References
- 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. [Article]
- 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]
- 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. [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]
- External Links
- KEGG Drug
- D10532
- PubChem Substance
- 347910434
- 1488293
- ChEMBL
- CHEMBL2108282
- RxList
- RxList Drug Page
- Drugs.com
- Drugs.com Drug Page
- Wikipedia
- Catridecacog
- FDA label
- Download (220 KB)
Clinical Trials
- Clinical Trials
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, powder, for solution Intravenous 2500 IU Kit Intravenous 2500 [iU]/3mL Powder, for solution Intravenous 2500 unit / vial - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Solid
- Experimental Properties
- 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 at November 13, 2015 19:08 / Updated at June 03, 2022 07:24