Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Factor xiii concentrate (human)
Drug ID BADD_D00867
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 [FDA 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)[A32363]. 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 [A18581]. Other drug products with similar structure and function to Factor XIII (human) include [DB09310], 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, [DB09310] is produced through recombinant DNA technology where the target protein is grown in yeast and then isolated [FDA 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 [FDA 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 hemostasis[A32363].
Indications and Usage 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 [FDA Label].
Marketing Status Not Available
ATC Code Not Available
DrugBank ID DB12909
KEGG ID Not Available
MeSH ID D005176
PubChem ID Not Available
TTD Drug ID Not Available
NDC Product Code 63833-518
Synonyms Factor XIII | Factor Thirteen | Coagulation Factor XIII | Factor XIII, Coagulation | XIII, Coagulation Factor | Factor XIII Transamidase | Transamidase, Factor XIII | Fibrinase | Laki Lorand Factor | Laki-Lorand Factor | Blood Coagulation Factor XIII | Factor 13 | Fibrin Stabilizing Factor | Stabilizing Factor, Fibrin
Chemical Information
Molecular Formula Not Available
CAS Registry Number 9013-56-3
SMILES Not Available
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Arthralgia15.01.02.001--
Blood pressure fluctuation24.06.01.002--Not Available
Chills15.05.03.016; 08.01.09.001--
Diarrhoea07.02.01.001--
Dyspnoea02.01.03.002; 22.02.01.004--
Epistaxis24.07.01.005; 22.04.03.001--
Haematoma24.07.01.001--
Head injury12.01.09.003--Not Available
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Influenza like illness08.01.03.010--
Nausea07.01.07.001--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Road traffic accident12.01.08.006--Not Available
Skin reaction23.03.03.013; 10.01.03.019--Not Available
Thrombosis24.01.01.006--Not Available
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Vomiting07.01.07.003--
Contusion24.07.06.001; 23.03.11.002; 15.03.01.008; 12.01.06.001--
Factor XIII Inhibition01.01.02.008--Not Available
Joint injury12.04.03.005--Not Available
Embolism24.01.01.009--
Limb injury12.01.09.008--Not Available
Transmission of an infectious agent via product27.02.01.002; 11.07.02.004--Not Available
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