Afstyla Description

One vial contains nominally 250/500/1000/2000/3000 IU recombinant, single chain coagulation factor VIII (rVIII-SingleChain, INN = lonoctocog alfa).
After reconstitution with 2.5 ml water for injections (250/500/1000 IU) the solution contains 100/200/400 IU/ml of rVIII-SingleChain. When reconstituted with 5 ml water for injections (2000/3000 IU) the solution contains 400/600 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 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: Sodium approximately 0.23-0.30 mmol/ml (5.4-7.0 mg/ml).
Excipients/Inactive Ingredients: L-Histidine, Polysorbate 80, Calcium chloride di-hydrate, Sodium chloride, Sucrose.