PEGylated
PEGylated Uses, Dosage, Side Effects, Food Interaction and all others data.
Antihemophilic Factor (Recombinant), PEGylated, was approved by the FDA in December 2016 as the product Adynovate .
Antihemophilic Factor (Recombinant), PEGylated, is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of approximately 280 kDa) covalently conjugated with at least one molecule of polyethylene glycol (MW 20 kDa) . It has been created to increase the half-life of factor VIII, which decreases dose frequency and decreases the occurrence of bleeding events , , .
PEGylation is the covalent attachment of a polyethylene glycol polymer, called PEG, to a drug or protein. PEGylation decreases factor VIII clearance and allowing for an increased duration of drug circulation in the plasma .
| Trade Name | PEGylated |
| Generic | Antihemophilic factor (recombinant), PEGylated |
| Antihemophilic factor (recombinant), PEGylated Other Names | Antihemophilic Factor (Recombinant), PEGylated, antihemophilic factor (recombinant), PEGylated-aucl |
| Type | |
| Weight | 284.0 Da |
| Groups | Approved, Investigational |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
For the management of hemophilia A (congenital factor VIII deficiency) , . This medication is a human antihemophilic factor indicated in adolescent and adult patients (12 years and older) with hemophilia A (congenital factor VIII deficiency). It is also used for on-demand treatment and control of bleeding and routine prophylaxis of bleeding episodes. It is not indicated for the treatment of von Willebrand disease .
PEGylated is also used to associated treatment for these conditions: Bleeding, Hemophilia A, Perioperative Blood Loss
How PEGylated works
PEG with Factor VIII effectively increases the molecular weight and size of the protein by creating a hydrophilic cloud around the molecule. This molecular change may reduce the susceptibility of this molecule to proteolytic degradation. It is also believed that PEGylation alters the surface charge of the protein that inhibits receptor-mediated clearance . This drug reduces binding to the LRP1 receptor, which normally clears factor VIII from the circulation , .
The plasma levels of Factor VIII are increased with replacement therapy, which allows for a temporary correction of the factor deficiency, thus a correction of the bleeding tendency .
Toxicity
Common adverse reactions reported in ≥1% of subjects in the clinical studies were headache and nausea .
Food Interaction
No interactions found.Volume of Distribution
At steady state: 0.56 ± 0.18 dL/Kg in children aged 12 to Label 0.43 ± 0.11 dL/kg in adults aged ≥18 years
Elimination Route
AUC0-Inf [IU·h/dL]:
1642 ± 752 in children aged 12 to Label 2264 ± 729 in adults ≥18 years
Clearance
2.27 ± 0.84 for adults ≥18 years
3.87 ± 3.31 for children 12 to Label
Innovators Monograph
You find simplified version here PEGylated
