| Definition | Antihemophilic Factor (Recombinant), PEGylated, was approved by the FDA in December 2016 as the product _Adynovate_ [FDA label].
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) [FDA label]. It has been created to increase the half-life of factor VIII, which decreases dose frequency and decreases the occurrence of bleeding events [A32067], [A32069], [FDA label].
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 [L1529]. |
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