Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: CSL Behring GmbH, Emil-von-Behring-Str. 76, 35041, Marburg, Germany
AFSTYLA 250 IU powder and solvent for solution for injection.
AFSTYLA 500 IU powder and solvent for solution for injection.
AFSTYLA 1000 IU powder and solvent for solution for injection.
AFSTYLA 1500 IU powder and solvent for solution for injection.
AFSTYLA 2000 IU powder and solvent for solution for injection.
AFSTYLA 2500 IU powder and solvent for solution for injection.
AFSTYLA 3000 IU powder and solvent for solution for injection.
| Pharmaceutical Form |
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Powder and solvent for solution for injection. White or slightly yellow powder or friable mass and clear, colourless solvent for solution for injection. pH: 6.6-7.3 |
AFSTYLA 250 IU powder and solvent for solution for injection: Each vial contains nominally 250 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa). After reconstitution with 2.5 ml water for injections the solution contains 100 IU/ml of rVIII-SingleChain.
AFSTYLA 500 IU powder and solvent for solution for injection: Each vial contains nominally 500 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa). After reconstitution with 2.5 ml water for injections the solution contains 200 IU/ml of rVIII-SingleChain.
AFSTYLA 1000 IU powder and solvent for solution for injection: Each vial contains nominally 1000 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa). After reconstitution with 2.5 ml water for injections the solution contains 400 IU/ml of rVIII-SingleChain.
AFSTYLA 1500 IU powder and solvent for solution for injection: Each vial contains nominally 1500 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa). When reconstituted with 5 ml water for injections the solution contains 300 IU/ml of rVIII-SingleChain.
AFSTYLA 2000 IU powder and solvent for solution for injection: Each vial contains nominally 2000 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa). When reconstituted with 5 ml water for injections the solution contains 400 IU/ml of rVIII-SingleChain.
AFSTYLA 2500 IU powder and solvent for solution for injection: Each vial contains nominally 2500 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa). When reconstituted with 5 ml water for injections the solution contains 500 IU/ml of rVIII-SingleChain.
AFSTYLA 3000 IU powder and solvent for solution for injection: Each vial contains nominally 3000 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa). When reconstituted with 5 ml water for injections the solution contains 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 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 Nglycosylation site. As the furin cleavage site present in wild type factor VIII between the Bdomain and the a3 domain was removed, AFSTYLA is expressed as a single-chain factor VIII molecule.
Excipient with known effect:
AFSTYLA 250, 500 and 1000 IU (2.5 ml solvent) Each vial contains 17.5 mg (0.76 mmol) of sodium.
AFSTYLA 1500, 2000, 2500 and 3000 IU (5 ml solvent) Each vial contains 35 mg (1.52 mmol) of sodium.
For the full list of excipients, see section 6.1
| Active Ingredient | Description | |
|---|---|---|
| Lonoctocog alfa |
Lonoctocog alfa is a recombinant human protein that replaces the missing coagulation factor VIII needed for effective hemostasis. Lonoctocog alfa is a single polypeptide chain with a truncated B-domain that allows for a covalent bridge to link the factor VIII heavy and light chains. Lonoctocog alfa has demonstrated a higher VWF affinity relative to full-length rFVIII. VWF stabilizes factor VIII and protects it from degradation. Activated lonoctocog alfa has an amino acid sequence identical to endogenous FVIIIa. |
| List of Excipients |
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Powder: L-Histidine Solvent: Water for injections |
AFSTYLA 250 IU powder and solvent for solution for injection: Powder (250 IU) in a 6 ml vial (type I glass) with a stopper (rubber), an orange disc (plastic), and a green striped cap (aluminium). 2.5 ml of solvent in a vial (type I glass) with a stopper (rubber), a disc (plastic), and a cap (aluminium).
AFSTYLA 500 IU powder and solvent for solution for injection: Powder (500 IU) in a 6 ml vial (type I glass) with a stopper (rubber), a blue disc (plastic), and a green striped cap (aluminium). 2.5 ml of solvent in a vial (type I glass) with a stopper (rubber), a disc (plastic), and a cap (aluminium).
AFSTYLA 1000 IU powder and solvent for solution for injection: Powder (1000 IU) in a 6 ml vial (type I glass) with a stopper (rubber), a green disc (plastic), and a green striped cap (aluminium). 2.5 ml of solvent in a vial (type I glass) with a stopper (rubber), a disc (plastic), and a cap (aluminium).
AFSTYLA 1500 IU powder and solvent for solution for injection: Powder (1500 IU) in a 10 ml vial (type I glass) with a stopper (rubber), a turquoise disc (plastic), and a green striped cap (aluminium). 5 ml of solvent in a vial (type I glass) with a stopper (rubber), a disc (plastic), and a cap (aluminium).
AFSTYLA 2000 IU powder and solvent for solution for injection: Powder (2000 IU) in a 10 ml vial (type I glass) with a stopper (rubber), a purple disc (plastic), and a green striped cap (aluminium). 5 ml of solvent in a vial (type I glass) with a stopper (rubber), a disc (plastic), and a cap (aluminium).
AFSTYLA 2500 IU powder and solvent for solution for injection: Powder (2500 IU) in a 10 ml vial (type I glass) with a stopper (rubber), a light grey disc (plastic), and a green striped cap (aluminium). 5 ml of solvent in a vial (type I glass) with a stopper (rubber), a disc (plastic), and a cap (aluminium).
AFSTYLA 3000 IU powder and solvent for solution for injection: Powder (3000 IU) in a 10 ml vial (type I glass) with a stopper (rubber), a yellow disc (plastic), and a green striped cap (aluminium). 5 ml of solvent in a vial (type I glass) with a stopper (rubber), a disc (plastic), and a cap (aluminium).
One pack with 250, 500 or 1000 IU containing:
1 vial with powder
1 vial with 2.5 ml water for injections
1 filter transfer device 20/20
One inner box containing:
1 disposable 5 ml syringe
1 venipuncture set
2 alcohol swabs
1 non-sterile plaster
One pack with 1500, 2000, 2500 or 3000 IU containing:
1 vial with powder
1 vial with 5 ml water for injections
1 filter transfer device 20/20
One inner box containing:
1 disposable 10 ml syringe
1 venipuncture set
2 alcohol swabs
1 non-sterile plaster
Not all pack sizes may be marketed.
CSL Behring GmbH, Emil-von-Behring-Str. 76, 35041, Marburg, Germany
EU/1/16/1158/001
EU/1/16/1158/002
EU/1/16/1158/003
EU/1/16/1158/004
EU/1/16/1158/005
EU/1/16/1158/006
EU/1/16/1158/007
Date of first authorisation: 04 January 2017
| Drug | Countries | |
|---|---|---|
| AFSTYLA | Austria, Brazil, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Japan, Lithuania, Netherlands, New Zealand, Poland, Singapore, Turkey |
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