==== Reference: Usmani SS, Bedi G, Samuel JS, Singh S, Kalra S, Kumar P, et al. (2017) THPdb: Database of FDA-approved peptide and protein therapeutics. PLoS ONE 12(7) e0181748.====

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Th1172 details
Primary information
ID1718
ThPP IDTh1172
Therapeutic Peptide/Protein NameCoagulation Factor XIII A-Subunit (Recombinant)
SequenceNA view full sequnce in fasta
Functional ClassificationIa
Molecular WeightNA
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting Point (℃)NA
Half Life5.1 (2.6) days
DescriptionCoagulation Factor XIII A-Subunit (Recombinant) is a recombinant human factor XIII-A2 homodimer composed of two factor XIII (FXIII) A-subunits. The FXIII A-subunit is a 731 amino acid chain with an acetylated N- terminal serine. When FXIII is activated by thrombin, a 37 amino acid peptide is cleaved from the N-terminus of the A-subunit. Coagulation Factor XIII A-Subunit (Recombinant) 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. No human or animal derived products are used in the manufacturing process.
Indication/DiseaseFor routine prophylaxis of bleeding in patients with congenital factor XIII A-Subunit deficiency.
PharmacodynamicsA qualitative assay of clot solubility is widely used as an indicator of FXIII deficiency; when performed correctly the test is positive only when the FXIII activity in the sample is close to zero. The results of standard coagulation tests are normal as it is the quality of the clot that is affected. In addition, at present there are no markers that can quantitatively assess the in vivo pharmacodynamics of FXIII.
Mechanism of ActionCoagulation Factor XIII A-Subunit (Recombinant) is a protransglutaminase (rFXIII [rA2] homodimer) and binds to free human FXIII B-subunit resulting in a heterotetramer [rA2B2] with a similar half-life to [A2B2]. rFXIII has been shown to be activated by thrombin in the presence of Ca2+. Activated rFXIII has been shown in dose-dependent manner to increase mechanical strength of fibrin clots, retard fibrinolysis, and rFXIII has been shown to enhance platelet adhesion to the site of injury. After combining with available plasma B-subunits, Coagulation Factor XIII A-subunit (Recombinant) has been shown to have the same pharmacodynamic properties in plasma as endogenous FXIII.
ToxicityNA
MetabolismNA
AbsorptionAUC (0-inf): 128.3 (40.5) (IU*h/mL)
Volume of DistributionNA
Clearance0.33 (0.11) (mL/h/kg)
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionCoagulation Factor XIII A-Subunit (Recombinant) may increase the thrombogenic activities of Coagulation factor VIIa.
TargetNA
Information of corresponding available drug in the market
Brand NameNA
CompanyNA
Brand DiscriptionNA
Prescribed forNA
Chemical NameNA
FormulationNA
Physcial AppearanceNA
Route of AdministrationNA
Recommended DosageNA
ContraindicationNA
Side EffectsNA
Useful Link
PubMed ID25031548, 27019464, 22451421
3-D StructureN.A.
Primary information
ID1719
ThPP IDTh1172
Therapeutic Peptide/Protein NameCoagulation Factor XIII A-Subunit (Recombinant)
SequenceNA view full sequnce in fasta
Functional ClassificationIa
Molecular WeightNA
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting Point (℃)NA
Half Life5.1 (2.6) days
DescriptionCoagulation Factor XIII A-Subunit (Recombinant) is a recombinant human factor XIII-A2 homodimer composed of two factor XIII (FXIII) A-subunits. The FXIII A-subunit is a 731 amino acid chain with an acetylated N- terminal serine. When FXIII is activated by thrombin, a 37 amino acid peptide is cleaved from the N-terminus of the A-subunit. Coagulation Factor XIII A-Subunit (Recombinant) 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. No human or animal derived products are used in the manufacturing process.
Indication/DiseaseFor routine prophylaxis of bleeding in patients with congenital factor XIII A-Subunit deficiency.
PharmacodynamicsA qualitative assay of clot solubility is widely used as an indicator of FXIII deficiency; when performed correctly the test is positive only when the FXIII activity in the sample is close to zero. The results of standard coagulation tests are normal as it is the quality of the clot that is affected. In addition, at present there are no markers that can quantitatively assess the in vivo pharmacodynamics of FXIII.
Mechanism of ActionCoagulation Factor XIII A-Subunit (Recombinant) is a protransglutaminase (rFXIII [rA2] homodimer) and binds to free human FXIII B-subunit resulting in a heterotetramer [rA2B2] with a similar half-life to [A2B2]. rFXIII has been shown to be activated by thrombin in the presence of Ca2+. Activated rFXIII has been shown in dose-dependent manner to increase mechanical strength of fibrin clots, retard fibrinolysis, and rFXIII has been shown to enhance platelet adhesion to the site of injury. After combining with available plasma B-subunits, Coagulation Factor XIII A-subunit (Recombinant) has been shown to have the same pharmacodynamic properties in plasma as endogenous FXIII.
ToxicityNA
MetabolismNA
AbsorptionAUC (0-inf): 128.3 (40.5) (IU*h/mL)
Volume of DistributionNA
Clearance0.33 (0.11) (mL/h/kg)
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetNA
Information of corresponding available drug in the market
Brand NameTretten
CompanyNovo Nordisk
Brand DiscriptionTRETTEN, Coagulation Factor XIII A-Subunit (Recombinant), is a recombinant human factor XIII-A2 homodimer composed of two factor XIII (FXIII) A-subunits. The FXIII A-subunit is a 731 amino acid chain with an acetylated N-terminal serine. When FXIII is activated by thrombin, a 37 amino acid peptide is cleaved from the N-terminus of the A-subunit.
Prescribed forTRETTEN, Coagulation Factor XIII A-Subunit (Recombinant), is indicated for routine prophylaxis for bleeding in patients with congenital factor XIII A-subunit deficiency.
Chemical NameNA
Formulation2000 - 3125 IU vial
Physcial AppearanceKit
Route of AdministrationNA
Recommended DosageTreatment should be initiated under the supervision of a physician experienced in the treatment of rare bleeding disorders. The dose for routine prophylaxis for bleeding in patients with congenital factor XIII (FXIII) A-subunit deficiency is 35 international units (IU) per kilogram body weight once monthly to achieve a target trough level of FXIII activity at or above 10% using a validated assay. Consider dose adjustment if adequate coverage is not achieved with the recommended 35 IU/kg dose.
ContraindicationTRETTEN is contraindicated in patients who have known hypersensitivity to the active substance or to any of the excipients
Side EffectsThe 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.
Useful Linkhttp://www.rxlist.com/tretten-drug.htm
PubMed ID25031548, 27019464, 22451422
3-D StructureN.A.
Primary information
ID1720
ThPP IDTh1172
Therapeutic Peptide/Protein NameCoagulation Factor XIII A-Subunit (Recombinant)
SequenceNA view full sequnce in fasta
Functional ClassificationIa
Molecular WeightNA
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting Point (℃)NA
Half Life5.1 (2.6) days
DescriptionCoagulation Factor XIII A-Subunit (Recombinant) is a recombinant human factor XIII-A2 homodimer composed of two factor XIII (FXIII) A-subunits. The FXIII A-subunit is a 731 amino acid chain with an acetylated N- terminal serine. When FXIII is activated by thrombin, a 37 amino acid peptide is cleaved from the N-terminus of the A-subunit. Coagulation Factor XIII A-Subunit (Recombinant) 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. No human or animal derived products are used in the manufacturing process.
Indication/DiseaseFor routine prophylaxis of bleeding in patients with congenital factor XIII A-Subunit deficiency.
PharmacodynamicsA qualitative assay of clot solubility is widely used as an indicator of FXIII deficiency; when performed correctly the test is positive only when the FXIII activity in the sample is close to zero. The results of standard coagulation tests are normal as it is the quality of the clot that is affected. In addition, at present there are no markers that can quantitatively assess the in vivo pharmacodynamics of FXIII.
Mechanism of ActionCoagulation Factor XIII A-Subunit (Recombinant) is a protransglutaminase (rFXIII [rA2] homodimer) and binds to free human FXIII B-subunit resulting in a heterotetramer [rA2B2] with a similar half-life to [A2B2]. rFXIII has been shown to be activated by thrombin in the presence of Ca2+. Activated rFXIII has been shown in dose-dependent manner to increase mechanical strength of fibrin clots, retard fibrinolysis, and rFXIII has been shown to enhance platelet adhesion to the site of injury. After combining with available plasma B-subunits, Coagulation Factor XIII A-subunit (Recombinant) has been shown to have the same pharmacodynamic properties in plasma as endogenous FXIII.
ToxicityNA
MetabolismNA
AbsorptionAUC (0-inf): 128.3 (40.5) (IU*h/mL)
Volume of DistributionNA
Clearance0.33 (0.11) (mL/h/kg)
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetNA
Information of corresponding available drug in the market
Brand NameTretten
CompanyNovo Nordisk Canada Inc
Brand DiscriptionTRETTEN, Coagulation Factor XIII A-Subunit (Recombinant), is a recombinant human factor XIII-A2 homodimer composed of two factor XIII (FXIII) A-subunits. The FXIII A-subunit is a 731 amino acid chain with an acetylated N-terminal serine. When FXIII is activated by thrombin, a 37 amino acid peptide is cleaved from the N-terminus of the A-subunit.
Prescribed forTRETTEN, Coagulation Factor XIII A-Subunit (Recombinant), is indicated for routine prophylaxis for bleeding in patients with congenital factor XIII A-subunit deficiency.
Chemical NameNA
Formulation15mg
Physcial Appearancepowder for solution
Route of AdministrationIV
Recommended DosageTreatment should be initiated under the supervision of a physician experienced in the treatment of rare bleeding disorders. The dose for routine prophylaxis for bleeding in patients with congenital factor XIII (FXIII) A-subunit deficiency is 35 international units (IU) per kilogram body weight once monthly to achieve a target trough level of FXIII activity at or above 10% using a validated assay. Consider dose adjustment if adequate coverage is not achieved with the recommended 35 IU/kg dose.
ContraindicationTRETTEN is contraindicated in patients who have known hypersensitivity to the active substance or to any of the excipients
Side EffectsThe 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.
Useful Linkhttp://www.rxlist.com/tretten-drug.htm
PubMed ID25031548, 27019464, 22451423
3-D StructureN.A.