A database of FDA approved therapeutic peptides and proteins
Details of Th1195 which contains 1 entries. |
| Entry 1 | |
| (1) Primary information | |
|---|---|
| ID | 1801 |
| ThPP ID | Th1195 |
| Therapeutic Peptide/Protein Name | Simoctocog Alfa |
| Sequence | NA view full sequnce in fasta |
| Functional Classification | Ia |
| Molecular Weight | 170000 |
| Chemical Formula | NA |
| Isoelectric Point | NA |
| Hydrophobicity | NA |
| Melting Point (℃) | NA |
| Half Life | 14.7 ± 10.4 hrs |
| Description | Simoctocog Alfa is a recombinant B-domain deleted (BDD) rFVIII produced in genetically modified human embryonic kidney (HEK) 293F cells. The harvested product is concentrated and purified by a series of chromatography steps. No animal proteins are used in the purification process and no human albumin is used as a stabiliser in the manufacture of Human-cl rhFVIII. Simoctocog Alfa is a glycoprotein consisting of 1440 amino acids with an approximate molecular mass of 170 kDa, comprising the FVIII domains A1-A2 + A3-C1-C2 whereas the B-domain, present in the full-length plasma-derived FVIII, has been deleted and replaced by a 16 amino acid linker. |
| Indication/Disease | Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). |
| Pharmacodynamics | The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions. When infused into a haemophiliac patient, factor VIII binds to von Willebrand factor in the patient’s circulation. Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin and a clot can be formed. Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as results of accidental or surgical trauma. By replacement therapy the plasma levels of factor VIII are increased, thereby temporarily enabling a correction of the factor VIII deficiency and correction of the bleeding tendencies. |
| Mechanism of Action | NA |
| Toxicity | NA |
| Metabolism | NA |
| Absorption | AUC: 22.6 ± 8.0 hr*IU/ml |
| Volume of Distribution | NA |
| Clearance | 3.0 ± 1.2 ml/hr/kg |
| Categories | Antihaemorrhagics: blood coagulation factor VIII |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | NA |
| Information of corresponding available drug in the market | |
| Brand Name | Nuwiq |
| Company | Octapharma Pharmazeutika Produktionsges M B H |
| Brand Discription | NA |
| Prescribed for | NA |
| Chemical Name | human coagulation factor VIII |
| Formulation | 250 IU |
| Physcial Appearance | Powder and solvent for solution |
| Route of Administration | Intravenous infusion |
| Recommended Dosage | The calculation of the required dose of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by approximately 2% of normal activity or 2 IU/dl. |
| Contraindication | Hypersensitivity to the active substance or to any of the excipients listed in section |
| Side Effects | Hypersensitivity which may include angiooedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing |
| Useful Link | http://ec.europa.eu/health/documents/community-register/2014/20140722129048/anx_129048_en.pdf |
| PubMed ID | 28103444, 27899309 |
| 3-D Structure | N.A. |