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ADYNOVATE 500IU powder and solvent for solution for injection: Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol.
ADYNOVATE 750IU powder and solvent for solution for injection: Each vial contains nominally 750 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol.
ADYNOVATE 1000IU powder and solvent for solution for injection: Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol.
ADYNOVATE 1500IU powder and solvent for solution for injection: Each vial contains nominally 1500 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol.
ADYNOVATE 2000IU powder and solvent for solution for injection: Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol.
ADYNOVATE 3000IU powder and solvent for solution for injection: Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol.
ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-use vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the nominal factor VIII activity in IU, determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma.
When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product: (See Table 1.)
Click on icon to see table/diagram/imageADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700 - 8000 IU/mg protein.
ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) [see Pharmacology: Mechanism of Action under Actions]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues.
The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins.
