Detailed description page of ThPDB2
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Th1379 details |
| Primary information | |
|---|---|
| ID | 13088 |
| Therapeutic ID | Th1379 |
| Protein Name | Catridecacog |
| Sequence | >Th1379_Catridecacog MSETSRTAFGGRRAVPPNNSNAAEDDLPTVELQGVVPRGVNLQEFLNVTSVHLFKERWDTNKVDHHTDKYENNKLIVRRGQSFYVQIDFSRPYDPRRDLFRVEYVIGRYPQENKGTYIPVPIVSELQSGKWGAKIVMREDRSVRLSIQSSPKCIVGKFRMYVAVWTPYGVLRTSRNPETDTYILFNPWCEDDAVYLDNEKEREEYVLNDIGVIFYGEVNDIKTRSWSYGQFEDGILDTCLYVMDRAQMDLSGRGNPIKVSRVGSAMVNAKDDEGVLVGSWDNIYAYGVPPSAWTGSVDILLEYRSSENPVRYGQCWVFAGVFNTFLRCLGIPARIVTNYFSAHDNDANLQMDIFLEEDGNVNSKLTKDSVWNYHCWNEAWMTRPDLPVGFGGWQAVDSTPQENSDGMYRCGPASVQAIKHGHVCFQFDAPFVFAEVNSDLIYITAKKDGTHVVENVDATHIGKLIVTKQIGGDGMMDITDTYKFQEGQEEERLALETALMYGAKKPLNTEGVMKSRSNVDMDFEVENAVLGKDFKLSITFRNNSHNRYTITAYLSANITFYTGVPKAEFKKETFDVTLEPLSFKKEAVLIQAGEYMGQLLEQASLHFFVTARINETRDVLAKQKSTVLTIPEIIIKVRGTQVVGSDMTVTVEFTNPLKETLRNVWVHLDGPGVTRPMKKMFREIRPNSTVQWEEVCRPWVSGHRKLIASMSSDSLRHVYGELDVQIQRRPSM |
| Molecular Weight | NA |
| Chemical Formula | NA |
| Isoelectric Point | NA |
| Hydrophobicity | NA |
| Melting point | NA |
| Half-life | 7.1 days |
| 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 [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 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) [A32363]. 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 [A18581]. 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 hemostasis[A32363]. Other drug products with similar structure and function to Coagulation Factor XIII A-Subunit (Recombinant) include [DB12909], 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 [FDA Label]. |
| Indication/Disease | For routine prophylaxis of bleeding in patients with congenital factor XIII A-Subunit deficiency. |
| Pharmacodynamics | NA |
| Mechanism of Action | NA |
| 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. |
| Metabolism | NA |
| Absorption | Following intravenous administration, the maximum concentration (Cmax) was found to be 0.48 IU/mL [FDA Label]. |
| NA | |
| Clearance | 0.41 mL/h/kg |
| Categories | Blood and Blood Forming Organs |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | Coagulation factor XIII B chain |
| Brand Name | Novothirteen |
| Company | Novo Nordisk |
| Brand Description | Novo Nordisk |
| Prescribed For | Intravenous |
| Chemical Name | 2500 IU |
| Formulation | NA |
| Physical Appearance | The most common side effect with NovoThirteen (which may affect more than 1 in 3 people) is headache. Other common side effects (which may affect up to 1 in 10 people) are leucopenia (low white blood cell counts, including neutrophils which fight infections), pain in the arms and legs, injection site pain, and the presence in the blood of antibodies that attach to factor XIII and of small protein fragments called ‘fibrin D-dimer’. |
| Route of Administration | NovoThirteen contains the active substance catridecacog. |
| Recommended Dosage | NovoThirteen is a medicine that prevents excessive bleeding in patients with an inherited blood clotting disorder called ‘congenital factor XIII A-subunit deficiency’. It is used to prevent bleeding and to treat any episodes of bleeding that occur during preventative treatment. |
| Contraindication | NA |
| Side Effects | NA |
| Useful Link 1 | Link |
| Useful Link 2 | Link |
| Remarks | NA |
| Primary information | |
|---|---|
| ID | 13089 |
| Therapeutic ID | Th1379 |
| Protein Name | Catridecacog |
| Sequence | >Th1379_Catridecacog MSETSRTAFGGRRAVPPNNSNAAEDDLPTVELQGVVPRGVNLQEFLNVTSVHLFKERWDTNKVDHHTDKYENNKLIVRRGQSFYVQIDFSRPYDPRRDLFRVEYVIGRYPQENKGTYIPVPIVSELQSGKWGAKIVMREDRSVRLSIQSSPKCIVGKFRMYVAVWTPYGVLRTSRNPETDTYILFNPWCEDDAVYLDNEKEREEYVLNDIGVIFYGEVNDIKTRSWSYGQFEDGILDTCLYVMDRAQMDLSGRGNPIKVSRVGSAMVNAKDDEGVLVGSWDNIYAYGVPPSAWTGSVDILLEYRSSENPVRYGQCWVFAGVFNTFLRCLGIPARIVTNYFSAHDNDANLQMDIFLEEDGNVNSKLTKDSVWNYHCWNEAWMTRPDLPVGFGGWQAVDSTPQENSDGMYRCGPASVQAIKHGHVCFQFDAPFVFAEVNSDLIYITAKKDGTHVVENVDATHIGKLIVTKQIGGDGMMDITDTYKFQEGQEEERLALETALMYGAKKPLNTEGVMKSRSNVDMDFEVENAVLGKDFKLSITFRNNSHNRYTITAYLSANITFYTGVPKAEFKKETFDVTLEPLSFKKEAVLIQAGEYMGQLLEQASLHFFVTARINETRDVLAKQKSTVLTIPEIIIKVRGTQVVGSDMTVTVEFTNPLKETLRNVWVHLDGPGVTRPMKKMFREIRPNSTVQWEEVCRPWVSGHRKLIASMSSDSLRHVYGELDVQIQRRPSM |
| Molecular Weight | NA |
| Chemical Formula | NA |
| Isoelectric Point | NA |
| Hydrophobicity | NA |
| Melting point | NA |
| Half-life | 7.1 days |
| 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 [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 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) [A32363]. 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 [A18581]. 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 hemostasis[A32363]. Other drug products with similar structure and function to Coagulation Factor XIII A-Subunit (Recombinant) include [DB12909], 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 [FDA Label]. |
| Indication/Disease | For routine prophylaxis of bleeding in patients with congenital factor XIII A-Subunit deficiency. |
| Pharmacodynamics | NA |
| Mechanism of Action | NA |
| 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. |
| Metabolism | NA |
| Absorption | Following intravenous administration, the maximum concentration (Cmax) was found to be 0.48 IU/mL [FDA Label]. |
| NA | |
| Clearance | 0.41 mL/h/kg |
| Categories | Blood Coagulation Factors |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | Coagulation factor XIII B chain |
| Brand Name | Tretten |
| Company | Novo Nordisk |
| Brand Description | Novo Nordisk |
| Prescribed For | Intravenous |
| Chemical Name | 2500 [iU]/3mL |
| Formulation | TRETTEN is contraindicated in patients who have known hypersensitivity to the active substance or to any of the excipients [See DESCRIPTION]. |
| Physical Appearance | headache pain in the extremities injection site pain increase in fibrin D dimer levels arthritis itching joint pain or skin redness. |
| Route of Administration | Tretten is an injectable medicine used to prevent bleeding in adults and children who have congenital factor XIII (FXIII) A-subunit deficiency. Tretten is man-made and does not contain animal or human materials. |
| Recommended Dosage | TRETTEN, Coagulation Factor XIII A-Subunit (Recombinant), is indicated for routine prophylaxis for bleeding in patients with congenital factor XIII A-subunit deficiency. |
| Contraindication | NA |
| Side Effects | Table 1 : Content of Reconstituted TRETTEN* |
| Useful Link 1 | Link |
| Useful Link 2 | Link |
| Remarks | NA |
| Primary information | |
|---|---|
| ID | 13090 |
| Therapeutic ID | Th1379 |
| Protein Name | Catridecacog |
| Sequence | >Th1379_Catridecacog MSETSRTAFGGRRAVPPNNSNAAEDDLPTVELQGVVPRGVNLQEFLNVTSVHLFKERWDTNKVDHHTDKYENNKLIVRRGQSFYVQIDFSRPYDPRRDLFRVEYVIGRYPQENKGTYIPVPIVSELQSGKWGAKIVMREDRSVRLSIQSSPKCIVGKFRMYVAVWTPYGVLRTSRNPETDTYILFNPWCEDDAVYLDNEKEREEYVLNDIGVIFYGEVNDIKTRSWSYGQFEDGILDTCLYVMDRAQMDLSGRGNPIKVSRVGSAMVNAKDDEGVLVGSWDNIYAYGVPPSAWTGSVDILLEYRSSENPVRYGQCWVFAGVFNTFLRCLGIPARIVTNYFSAHDNDANLQMDIFLEEDGNVNSKLTKDSVWNYHCWNEAWMTRPDLPVGFGGWQAVDSTPQENSDGMYRCGPASVQAIKHGHVCFQFDAPFVFAEVNSDLIYITAKKDGTHVVENVDATHIGKLIVTKQIGGDGMMDITDTYKFQEGQEEERLALETALMYGAKKPLNTEGVMKSRSNVDMDFEVENAVLGKDFKLSITFRNNSHNRYTITAYLSANITFYTGVPKAEFKKETFDVTLEPLSFKKEAVLIQAGEYMGQLLEQASLHFFVTARINETRDVLAKQKSTVLTIPEIIIKVRGTQVVGSDMTVTVEFTNPLKETLRNVWVHLDGPGVTRPMKKMFREIRPNSTVQWEEVCRPWVSGHRKLIASMSSDSLRHVYGELDVQIQRRPSM |
| Molecular Weight | NA |
| Chemical Formula | NA |
| Isoelectric Point | NA |
| Hydrophobicity | NA |
| Melting point | NA |
| Half-life | 7.1 days |
| 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 [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 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) [A32363]. 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 [A18581]. 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 hemostasis[A32363]. Other drug products with similar structure and function to Coagulation Factor XIII A-Subunit (Recombinant) include [DB12909], 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 [FDA Label]. |
| Indication/Disease | For routine prophylaxis of bleeding in patients with congenital factor XIII A-Subunit deficiency. |
| Pharmacodynamics | NA |
| Mechanism of Action | NA |
| 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. |
| Metabolism | NA |
| Absorption | Following intravenous administration, the maximum concentration (Cmax) was found to be 0.48 IU/mL [FDA Label]. |
| NA | |
| Clearance | 0.41 mL/h/kg |
| Categories | Hemostatics |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | Coagulation factor XIII B chain |
| Brand Name | Tretten |
| Company | Novo Nordisk |
| Brand Description | Novo Nordisk |
| Prescribed For | Intravenous |
| Chemical Name | 2500 unit / vial |
| Formulation | TRETTEN is contraindicated in patients who have known hypersensitivity to the active substance or to any of the excipients [See DESCRIPTION]. |
| Physical Appearance | headache pain in the extremities injection site pain increase in fibrin D dimer levels arthritis itching joint pain or skin redness. |
| Route of Administration | Tretten is an injectable medicine used to prevent bleeding in adults and children who have congenital factor XIII (FXIII) A-subunit deficiency. Tretten is man-made and does not contain animal or human materials. |
| Recommended Dosage | TRETTEN, Coagulation Factor XIII A-Subunit (Recombinant), is indicated for routine prophylaxis for bleeding in patients with congenital factor XIII A-subunit deficiency. |
| Contraindication | NA |
| Side Effects | Table 1 : Content of Reconstituted TRETTEN* |
| Useful Link 1 | Link |
| Useful Link 2 | Link |
| Remarks | NA |