BDDrFVIII
BDDrFVIII Uses, Dosage, Side Effects, Food Interaction and all others data.
BDDrFVIII, also known as BDDrFVIII (B domain deleted recombinant factor VIII), is a recombinant DNA-based drug with functional characteristics comparable to those of endogenous coagulation Factor VIII, the essential human blood clotting protein that is impaired in Hemophilia A. BDDrFVIII is identical in sequence to endogenously produced Factor VIII, but does not contain the B-domain, which has no known biological function. BDDrFVIII is produced through recombinant DNA technology and purification, resulting in a 1438 amino acid, 170 kDa protein . Clinical evaluation has shown that BDDrFVIII is pharmacokinetically equivalent to full-length recombinant FVIII .
Also known as Anti-Hemophilic Factor (AHF), endogenous Factor VIII is essential to the clotting process in the body due to its involvement in the clotting cascade where it is responsible for acting as a co-factor to Factor IX. Activation of Factor IX leads to a cascade of signals that results in activation of Factor X, which then results in the conversion of prothrombin to thrombin, and as a result, leads to the conversion of fibrinogen to fibrin, the fibrous protein that creates the scaffold of the clot. Replacement of Factor VIII is essential for the treatment of Hemophilia A, which is caused by mutations in the Factor VIII gene, leading to a functional deficiency or complete loss of protein. Congenital loss or deficiency of Factor VIII results in the physiologic impairment of the coagulation clotting cascade, and as a result, leads to easy bruising and bleeding. Bleeding can range in severity from minor concerns, such as nosebleeds, to more serious events such as hemorrhaging in the joints, brain, or digestive tract .
Exogenous replacement of Factor VIII is currently the cornerstone of Hemophilia treatment and is used for the prophylaxis and control of bleeding episodes. Treatment has drastically improved since the 1960s when Factor VIII protein was primarily purified from human plasma, rather than being produced through recombinant DNA technology. Unfortunately, purification of protein from human plasma carries an increased risk of transmission of blood-borne diseases such as HIV and Hepatitis, which in part contributed to the Tainted Blood Scandal in the 1980s . Use of recombinant DNA-derived clotting factor treatments, such as BDDrFVIII, has reduced this risk.
Trade Name | BDDrFVIII |
Generic | Moroctocog alfa |
Moroctocog alfa Other Names | Antihemophilic factor (recombinant, B-domain deleted), plasma/albumin free, Antihemophilic factor recombinant plasma/albumin free, Antihemphilic factor, recombinant human B-domain deleted, B-domain deleted recombinant factor VIII, BDDrFVIII, Human factor VIII, recombinant B-domain deleted, Moroctocog alfa |
Type | |
Weight | 173000.0 Da (glycosylated) |
Groups | Approved |
Therapeutic Class | |
Manufacturer | |
Available Country | |
Last Updated: | September 19, 2023 at 7:00 am |
Uses
BDDrFVIII is a recombinant Factor VIII used to treat hemophilia A to control bleeding.
Moroctocog Alfa is approved by Health Canada for the control and prevention of hemorrhagic episodes and for routine and surgical prophylaxis in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia).
Moroctocog Alfa is also approved by the European Medicines Agency for the treatment and prophylaxis of bleeding in patients with Haemophilia A (congenital factor VIII deficiency).
BDDrFVIII is also used to associated treatment for these conditions: Bleeding
How BDDrFVIII works
Antihemophilic factor (AHF) is a protein found in normal plasma which is necessary for clot formation. The administration of AHF provides an increase in plasma levels of AHF and can temporarily correct the coagulation defect of patients with hemophilia A (classical hemophilia). As factor VIII is the specific clotting factor deficient in patients with hemophilia A, replacement of clotting factor with BDDrFVIII, also known as BDDrFVIII (B domain deleted recombinant factor VIII), is the cornerstone of the prevention and treatment of bleeding for this disorder.
Food Interaction
No interactions found.Volume of Distribution
Mean steady-state volume of distribution = 65.1 (± 35.1) mL/kg
Elimination Route
Cmax = 1.08±0.22 IU⋅hr/mL Cmax = 1.12 (±0.19) IU/mL
Half Life
Mean terminal elimination half-life = 11.8 (± 5.1) hours Half-life = 11.2 ± 5.0 hours
Clearance
Mean clearance = 4.21 (± 2.08) mL/h•kg Clearance = 4.51 ± 2.23 mL/h•kg
Innovators Monograph
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