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Each vial contains nominally 500 IU recombinant, single-chain coagulation factor VIII (rVIII-SingleChain, INN = lonoctocog alfa). After reconstitution with 2.5 ml water for injections the solution contains 200 IU/ml of rVIII-SingleChain.
The potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of AFSTYLA is 7400 - 16000 IU/mg protein.
AFSTYLA is a single-chain recombinant human factor VIII produced in Chinese hamster ovary (CHO) cells. It is a construct where most of the B-domain occurring in wild-type, full-length factor VIII and 4 amino acids of the adjacent acidic a3 domain were removed (amino acids 765 to 1652 of full-length factor VIII).
The newly formed linkage of the heavy and light chain of factor VIII introduces a new N-glycosylation site. As the furin cleavage site present in wild type factor VIII between the B-domain and the a3 domain was removed, AFSTYLA is expressed as a single-chain factor VIII molecule.
Excipient with known effect: Each vial contains 17.5 mg (0.76 mmol) of sodium.
pH: 6.6 - 7.3.
Osmolality: 500 - 600 mOsm/kg.
Excipients/Inactive Ingredients: Powder: L-Histidine, Polysorbate 80, Calcium chloride dihydrate, Sodium chloride, Sucrose.
Solvent: Water for injections.
