| Primary information |
|---|
| ThPP ID | Th1227 |
| Therapeutic Peptide/Protein Name | Efmoroctocog alfa |
| Sequence | NA view full sequnce in fasta |
| Functional Classification | Ib |
| Molecular Weight | NA |
| Chemical Formula | NA |
| Isoelectric Point | NA |
| Hydrophobicity | NA |
| Melting Point (℃) | NA |
| Half Life | NA |
| Description | Efmoroctocog alfa is a long-acting, fully-recombinant factor VIII Fc fusion protein. |
| Indication/Disease | For the treatment of Haemophilia A. |
| Pharmacodynamics | NA |
| Mechanism of Action | Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily. The active substance in Elocta, efmoroctocog alfa, works in the body in the same way as human factor VIII. It replaces the missing factor VIII, thereby helping the blood to clot and giving temporary control of bleeding. |
| Toxicity | NA |
| Metabolism | NA |
| Absorption | NA |
| Volume of Distribution | NA |
| Clearance | NA |
| Categories | Antihemophilic Factor |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | No interactions of human coagulation factor VIII (rDNA) with other medicinal products have been reported. |
| Target | NA |
| Information of corresponding available drug in the market |
|---|
| Brand Name | ELOCTA |
| Company | NA |
| Brand Discription | Efmoroctocog alfa (recombinant human coagulation factor VIII, Fc fusion protein (rFVIIIFc)) has 1890 amino acids. It is produced by recombinant DNA technology in a human embryonic kidney (HEK) cell line without the addition of any exogenous human- or animal-derived protein in the cell culture process, purification or final formulation. |
| Prescribed for | Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). |
| Chemical Name | NA |
| Formulation | 0.6 mmol (or 14 mg) sodium per vial |
| Physcial Appearnce | Powder and solvent for solution for injection |
| Route of Administration | Intravenous |
| Recommended Dosage | The calculation of the required dose of recombinant factor VIII Fc is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by 2 IU/dL. The required dose is determined using the following formula: Required units = body weight (kg) x desired factor VIII rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL) |
| Contraindication | Hypersensitivity to the active substance (recombinant human coagulation factor VIII, and/or Fc domain) |
| Side Effects | Hypersensitivity or allergic reactions (which may include swelling of the face, rash, hives, tightness of the chest and difficulty breathing, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hypotension, lethargy, nausea, restlessness, tachycardia) have been observed rarely and may in some cases progress to severe anaphylaxis. |
| Useful Link | http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003964/WC500198642.pdf |
| PubMed ID | 27487799 |
| 3-D Structure | N.A. |