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| Primary information |
|---|
| ID | 10827 |
| Therapeutic ID | Th1193 |
| Protein Name | Turoctocog alfa |
| Sequence | >Th1193_Turoctocog_alfa
ATRRYYLGAVELSWDYMQSDLGELPVDARFPPRVPKSFPFNTSVVYKKTLFVEFTDHLFNIAKPRPPWMGLLGPTIQAEVYDTVVITLKNMASHPVSLHAVGVSYWKASEGAEYDDQTSQREKEDDKVFPGGSHTYVWQVLKENGPMASDPLCLTYSYLSHVDLVKDLNSGLIGALLVCREGSLAKEKTQTLHKFILLFAVFDEGKSWHSETKNSLMQDRDAASARAWPKMHTVNGYVNRSLPGLIGCHRKSVYWHVIGMGTTPEVHSIFLEGHTFLVRNHRQASLEISPITFLTAQTLLMDLGQFLLFCHISSHQHDGMEAYVKVDSCPEEPQLRMKNNEEAEDYDDDLTDSEMDVVRFDDDNSPSFIQIRSVAKKHPKTWVHYIAAEEEDWDYAPLVLAPDDRSYKSQYLNNGPQRIGRKYKKVRFMAYTDETFKTREAIQHESGILGPLLYGEVGDTLLIIFKNQASRPYNIYPHGITDVRPLYSRRLPKGVKHLKDFPILPGEIFKYKWTVTVEDGPTKSDPRCLTRYYSSFVNMERDLASGLIGPLLICYKESVDQRGNQIMSDKRNVILFSVFDENRSWYLTENIQRFLPNPAGVQLEDPEFQASNIMHSINGYVFDSLQLSVCLHEVAYWYILSIGAQTDFLSVFFSGYTFKHKMVYEDTLTLFPFSGETVFMSMENPGLWILGCHNSDFRNRGMTALLKVSSCDKNTGDYYEDSYEDISAYLLSKNNAIEPRSFSQNSRHPSQNPPVLKRHQR
|
| Molecular Weight | 166000 |
| Chemical Formula | C7480H11379N1999O2194S68 |
| Isoelectric Point | NA |
| Hydrophobicity | NA |
| Melting point | NA |
| Half-life | 16 hours |
| Description | Turoctocog alfa is a recombinant factor VIII (rFVIII) with a truncated B-domain made from the sequence coding for 10 amino acids from the N-terminus and 11 amino acids from the C-terminus of the naturally occurring B-domain. Turoctocog alfa is produced in Chinese hamster ovary (CHO) cells without addition of any human- or animal-derived materials. During secretion, some rFVIII molecules are cleaved at the C-terminal of the heavy chain (HC) at amino acid 720, and a monoclonal antibody binding C-terminal to this position is used in the purification process allowing isolation of the intact rFVIII. It was first launched in Germany in January 2014 and has been approved in the US, EU and Japan |
| Indication/Disease | In the safety and efficacy trial for prevention and treatment of bleeds, in hemophilia patients |
| Pharmacodynamics | NA |
| Mechanism of Action | NA |
| Toxicity | In preclinical safety studies, there was a change in reported systolic pressure after 2-weeks of multiple dosing.[L1107] Thrombus formation, cardiovascular, neurological or respiratory effects are not expected to be a safety concern.[L1108] |
| Metabolism | Turoctocog alfa is expected to be cleaved by proteolysis into small individual aminoacids that constitute them after receptor mediated cell endocytosis.[L1108] |
| Absorption | In pre-clinical studies, the absorption half-life was reported wot be 5.4 hours.[A31506] The absorption profile varies depending on the age of the patient where the AUC is 9.92, 11.09 and 15.26 IU hour/ml for the age range of 0-6 years, 6-12 years and over 12 years old respectively. The Cmax according to the different age groups is 1, 1.07 and 1.226 IU/ml for the age range of 0-6 years, 6-12 years and over 12 years old respectively.[L1107] |
| In pre-clinical studies, turoctocog distribution was studied based on a two model compartment and it resulted in 59 ml/kg in the central compartment and 13 ml/kg in the peripheral compartment. It also presented an inter-compartmental flow of 0.66 ml/hour kg.[A31506] |
| Clearance | In pre-clinical studies, turoctocog clearance was reported to be 6.5 ml/hour kg.[A31506] |
| Categories | Amino Acids, Peptides, and Proteins,Biological Factors,Blood Coagulation Factors,Blood Proteins,Hemostatics,Proteins,Recombinant Proteins |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | Coagulation factor IX,Coagulation factor X,Prothrombin |
| Brand Name | Zonovate |
| Company | Novo Nordisk Canada Inc |
| Brand Description | Novo Nordisk Canada Inc |
| Prescribed For | Treatment and control of bleeding episodes; Perioperative management; Routine prophylaxis to prevent or reduce the frequency of bleeding episodes. |
| Chemical Name | NA |
| Formulation | Zonovate®is available in strengths of 250, 500, 1000, 1500, 2000 or 3000 IU/vial. The solvent for reconstitution of Zonovate® is 0.9% sodium chloride solution and is supplied as a clear colorless solutionin a prefilled syringe. |
| Physical Appearance | sterile, non-pyrogenic, white or slightly yellow powder |
| Route of Administration | Intravenous |
| Recommended Dosage | in minor Degree of Hemorrhage 20-40 IU/dl required. Repeat every 12 to 24 hours, at least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved. In major Life threatening hemorrhages 60-100 IU/dl required with repeated injection every 8 to 24 hours until threat is resolved |
| Contraindication | Hypersensitivity |
| Side Effects | NA |
| Useful Link 1 | Link |
| Useful Link 2 | NA |
| Remarks | NA |