ELOCTA and solvent(Northern Ireland)
ELOCTA and solvent(Northern Ireland) Uses, Dosage, Side Effects, Food Interaction and all others data.
ELOCTA and solvent(Northern Ireland) is a fully recombinant factor VIII-Fc fusion protein (rFVIIIFc) with an extended half-life compared with conventional factor VIII (FVIII) preparations, including recombinant FVIII (rFVIII) products such as Moroctocog alfa. It is an antihemorrhagic agent used in replacement therapy for patients with haemophilia A (congenital factor VIII deficiency). It is suitable for all age groups. Haemophilia A is a rare bleeding disorder associated with a slow clotting process caused by the deficiency of factor VIII. Patients with this disorder are more susceptible to recurrent bleeding episodes and excessive bleeding following minor traumatic injuries or surgical procedures . Prophylactic treatment may dramatically improve the management of severe haemophilia A in the future by reducing joint bleeding and other hemorrhages that cause chronic pain and disability to patients . Prophylaxis has also shown to reduce the formation of neutralizing anti-FVIII antibodies, or inhibitors .
Factor VIII is a blood coagulant factor involved in the intrinsic pathway to form fibrin, or a blood clot. ELOCTA and solvent(Northern Ireland) is a first commercially available rFVIII-Fc fusion protein (rFVIIIFc) where the conjugated molecule of rFVIII to polyethylene glycol is covalently fused to the dimeric Fc domain of human immunoglobulin G1, a long-lived plasma protein . The B domain of factor VIII is deleted. In animal models of haemophilia, efmoroctocog alfa demonstrated an approximately two-fold longer t½ than commercially available rFVIII products .
Other drug products with similar structure and function to ELOCTA and solvent(Northern Ireland) include Moroctocog alfa, which is produced by recombinant DNA technology and is identical in sequence to endogenously produced Factor VIII, but does not contain the B-domain, which has no known biological function, and Antihemophilic factor human, which is purified endogenous Factor VIII from human pooled blood and contains both A- and B-subunits.
| Trade Name | ELOCTA and solvent(Northern Ireland) |
| Generic | Efmoroctocog alfa |
| Efmoroctocog alfa Other Names | Antihemophilic Factor (Recombinant BDD), FC Fusion Protein, Antihemophilic factor (recombinant, FC fusion protein), Coagulation factor VIII recombinant immunoglubulin g1 fusion protein, Efmoroctocog alfa |
| Type | |
| Formula | C9736H14863N2591O2855S78 |
| Weight | 220000.0 Da (Apparent, B-domain deleted) |
| Protein binding | Like endogenous factor VIII, efmoroctocog alfa binds to von Willebrand factor in the circulation. |
| Groups | Approved, Investigational |
| Therapeutic Class | |
| Manufacturer | Swedish Orphan Biovitrum Ltd |
| Available Country | United Kingdom |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
ELOCTA and solvent(Northern Ireland) is a recombinant Factor VIII used to treat and prevent bleeding in hemophilia A.
Indicated for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) .
ELOCTA and solvent(Northern Ireland) is also used to associated treatment for these conditions: Bleeding, Perioperative Blood Loss
How ELOCTA and solvent(Northern Ireland) works
Factor VIII exists in a circulating protein complex consisting of two molecules via a non-covalent binding interaction; Factor VIII and von Willebrand factor. This complex remains inactive until the coagulation cascade is initiated, which activated factor VIII. Factor VIII is released from the protein complex upon activation and acts as a cofactor for factor IX-mediated conversion of factor X to activated factor X on phospholipid surfaces. Activated factor X is critical in converting prothrombin into thrombin and sequentially, thrombin converts fibrinogen to fibrin for the formation of a blood clot .
Haemophilia A is a X-linked hereditary disorder of blood coagulation due to decreased levels of functional factor. The disorder can lead to various disabling complications including bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma . ELOCTA and solvent(Northern Ireland) is a recombinant fusion protein comprised of a single molecule of B-domain deleted human coagulation factor VIII covalently linked to the Fc domain of human immunoglobulin G1. It acts as a replacement therapy to increase the plasma levels of factor VIII, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies .
Extended half-life of efmoroctocog alfa relative to endogenous factor VIII is explained by the Fc region binding to the neonatal Fc receptor expressed throughout life; the receptor is part of a naturally occurring pathway that protects immunoglobulins (and Fc fusion proteins) from lysosomal degradation by cycling them back into the circulation .
Toxicity
Based on the findings from acute and repeated dose toxicity studies, efmoroctocog alfa displays no special hazard for humans. Studies to assess the genotoxicity, carcinogenicity, toxicity to reproduction or embryo-foetal development of efmoroctocog alfa have not been conducted. In a placental transfer study, efmoroctocog alfa has been shown to cross the placenta in small amounts in mice .
Food Interaction
No interactions found.Volume of Distribution
Following a single intravenous dose of 50 IU/kg in previously-treated adult patients with severe haemophilia A, mean volume of distribution at steady state (Vss) ranged from 49.1 to 52.6 mL/kg. Mean Vss in adolescent patients 12 to 18 years of age ranged from 57.6 to 59.4mL/kg. Mean Vss in pediatric patients < 12 years of age ranged from 49.5 to 63.1 mL/kg .
Elimination Route
Following a single intravenous dose of 50 IU/kg in previously-treated adult patients with severe haemophilia A, mean peak plasma concentrations (Cmax) ranged from 108 to 131 IU/dL. Mean area under the FVIII activity time curve (AUC/Dose) ranged from 47.5 to 51.2 IUxh/dL per IU/kg. Mean AUC/Dose in adolescent patients 12 to 18 years of age ranged from 38.2 to 40.8 IUxh/dL per IU/kg. Mean AUC/Dose in pediatric patients < 12 years of age ranged from 25.9 to 38.4 IUxh/dL per IU/kg .
Half Life
Following a single intravenous dose of 50 IU/kg in previously-treated adult patients with severe haemophilia A, mean half life (t1/2) ranged from 19 to 20.9 h. Mean t1/2 in adolescent patients 12 to 18 years of age ranged from 16 to 17.5 h. Mean t1/2 in pediatric patients < 12 years of age ranged from 12.3 to 15.9 h .
Clearance
Following a single intravenous dose of 50 IU/kg in previously-treated adult patients with severe haemophilia A, mean clearance (CL) rate ranged from 1.95 to 2.11 mL/h/kg. Mean CL in adolescent patients 12 to 18 years of age ranged from 2.45 to 2.62 mL/h/kg. Mean t1/2 in pediatric patients < 12 years of age ranged from 2.61 to 3.86 mL/h/kg .
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