Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Ascendis Pharma Endocrinology Division A/S, Tuborg Boulevard 12, DK-2900 Hellerup, Denmark
Skytrofa 3 mg powder and solvent for solution for injection in cartridge.
Skytrofa 3.6 mg powder and solvent for solution for injection in cartridge.
Skytrofa 4.3 mg powder and solvent for solution for injection in cartridge.
Skytrofa 5.2 mg powder and solvent for solution for injection in cartridge.
Skytrofa 6.3 mg powder and solvent for solution for injection in cartridge.
Skytrofa 7.6 mg powder and solvent for solution for injection in cartridge.
Skytrofa 9.1 mg powder and solvent for solution for injection in cartridge.
Skytrofa 11 mg powder and solvent for solution for injection in cartridge.
Skytrofa 13.3 mg powder and solvent for solution for injection in cartridge.
| Pharmaceutical Form |
|---|
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Powder and solvent for solution for injection (injection). White to off-white powder. The solvent is a clear and colourless solution. |
Skytrofa consists of somatropin transiently conjugated to a methoxypolyethylene glycol carrier (mPEG) via a proprietary TransCon Linker. The strength of Skytrofa always indicates the quantity of the somatropin moiety.
Skytrofa 3 mg powder and solvent for solution for injection in cartridge:
Each dual-chamber cartridge contains 3 mg of somatropin* equivalent to 8.6 mg of lonapegsomatropin and 0.279 mL of solvent. After reconstitution the concentration based on somatropin** protein is 11 mg/mL.
Skytrofa 3.6 mg powder and solvent for solution for injection in cartridge:
Each dual-chamber cartridge contains 3.6 mg of somatropin* equivalent to 10.3 mg of lonapegsomatropin and 0.329 mL of solvent. After reconstitution the concentration based on somatropin** protein is 11 mg/mL.
Skytrofa 4.3 mg powder and solvent for solution for injection in cartridge:
Each dual-chamber cartridge contains 4.3 mg of somatropin* equivalent to 12.3 mg of lonapegsomatropin and 0.388 mL of solvent. After reconstitution the concentration based on somatropin** protein is 11 mg/mL.
Skytrofa 5.2 mg powder and solvent for solution for injection in cartridge:
Each dual-chamber cartridge contains 5.2 mg of somatropin* equivalent to 14.8 mg of lonapegsomatropin and 0.464 mL of solvent. After reconstitution the concentration based on somatropin** protein is 11 mg/mL.
Skytrofa 6.3 mg powder and solvent for solution for injection in cartridge:
Each dual-chamber cartridge contains 6.3 mg of somatropin* equivalent to 18 mg of lonapegsomatropin and 0.285 mL of solvent. After reconstitution the concentration based on somatropin** protein is 22 mg/mL.
Skytrofa 7.6 mg powder and solvent for solution for injection in cartridge:
Each dual-chamber cartridge contains 7.6 mg of somatropin* equivalent to 21.7 mg of lonapegsomatropin and 0.338 mL of solvent. After reconstitution the concentration based on somatropin** protein is 22 mg/mL.
Skytrofa 9.1 mg powder and solvent for solution for injection in cartridge:
Each dual-chamber cartridge contains 9.1 mg of somatropin* equivalent to 25.9 mg of lonapegsomatropin and 0.4 mL of solvent. After reconstitution the concentration based on somatropin** protein is 22 mg/mL.
Skytrofa 11 mg powder and solvent for solution for injection in cartridge:
Each dual-chamber cartridge contains 11 mg of somatropin* equivalent to 31.4 mg of lonapegsomatropin and 0.479 mL of solvent. After reconstitution the concentration based on somatropin** protein is 22 mg/mL.
Skytrofa 13.3 mg powder and solvent for solution for injection in cartridge:
Each dual-chamber cartridge contains 13.3 mg of somatropin* equivalent to 37.9 mg of lonapegsomatropin and 0.574 mL of solvent. After reconstitution the concentration based on somatropin** protein is 22 mg/mL.
* The strength indicates the quantity of the somatropin moiety without consideration of the mPEG-linker.
** Produced in Escherichia coli cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Lonapegsomatropin |
Lonapegsomatropin is a long-acting ‘prodrug’ of somatropin. Lonapegsomatropin consists of the parent drug, somatropin, that is transiently conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker. The carrier has a shielding effect that minimizes renal excretion and receptor-mediated clearance of lonapegsomatropin. |
| List of Excipients |
|---|
|
Powder: Succinic acid Solvent: Water for injections |
Glass cartridge (Type I glass) with two chambers separated by a rubber stopper (bromobutyl). The cartridge is closed by a rubber stopper (bromobutyl) in one end and by a rubber closure disc (bromobutyl) in the other end. The cartridge is mounted in a plastic needle adaptor.
Each pack contains 4 single-use dual-chamber cartridges packed in individual blisters and 6 disposable injection needles 0.25 mm x 4 mm (31G x 5/32"). Each dual-chamber cartridge has a specific label with assigned two-colour coding ribbons that is only used by the Auto-Injector to select the correct reconstitution settings. Strength colours are indicated on the carton and blister foil and should be used to differentiate the individual strengths.
Skytrofa 3 mg powder and solvent for solution for injection in cartridge:
Each dual-chamber cartridge contains 3 mg of somatropin as powder in the first chamber and 0.279 mL of solvent in the second chamber. The cartridge two-colour label (bottom/top) is yellow/green. The strength colour on the carton and blister is light apricot.
Skytrofa 3.6 mg powder and solvent for solution for injection in cartridge:
Each dual-chamber cartridge contains 3.6 mg of somatropin as powder in the first chamber and 0.329 mL of solvent in the second chamber. The cartridge two-colour label (bottom/top) is yellow/cyan. The strength colour on the carton and blister is cyan.
Skytrofa 4.3 mg powder and solvent for solution for injection in cartridge:
Each dual-chamber cartridge contains 4.3 mg of somatropin as powder in the first chamber and 0.388 mL of solvent in the second chamber. The cartridge two-colour label (bottom/top) is yellow/pink. The strength colour on the carton and blister is dark grey.
Skytrofa 5.2 mg powder and solvent for solution for injection in cartridge:
Each dual-chamber cartridge contains 5.2 mg of somatropin as powder in the first chamber and 0.464 mL of solvent in the second chamber. The cartridge two-colour label (bottom/top) is green/pink. The strength colour on the carton and blister is yellow.
Skytrofa 6.3 mg powder and solvent for solution for injection in cartridge:
Each dual-chamber cartridge contains 6.3 mg of somatropin as powder in the first chamber and 0.285 mL of solvent in the second chamber. The cartridge two-colour label (bottom/top) is cyan/yellow. The strength colour on the carton and blister is orange.
Skytrofa 7.6 mg powder and solvent for solution for injection in cartridge:
Each dual-chamber cartridge contains 7.6 mg of somatropin as powder in the first chamber and 0.338 mL of solvent in the second chamber. The cartridge two-colour label (bottom/top) is cyan/pink. The strength colour on the carton and blister is dark purple.
Skytrofa 9.1 mg powder and solvent for solution for injection in cartridge:
Each dual-chamber cartridge contains 9.1 mg of somatropin as powder in the first chamber and 0.4 mL of solvent in the second chamber. The cartridge two-colour label (bottom/top) is pink/yellow. The strength colour on the carton and blister is golden brown.
Skytrofa 11 mg powder and solvent for solution for injection in cartridge:
Each dual-chamber cartridge contains 11 mg of somatropin as powder in the first chamber and 0.479 mL of solvent in the second chamber. The cartridge two-colour label (bottom/top) is pink/green. The strength colour on the carton and blister is dark blue.
Skytrofa 13.3 mg powder and solvent for solution for injection in cartridge:
Each dual-chamber cartridge contains 13.3 mg of somatropin as powder in the first chamber and 0.574 mL of solvent in the second chamber. The cartridge two-colour label (bottom/top) is pink/cyan. The strength colour on the carton and blister is dark red.
Ascendis Pharma Endocrinology Division A/S, Tuborg Boulevard 12, DK-2900 Hellerup, Denmark
Date of first authorisation: 11 January 2022
| Drug | Countries | |
|---|---|---|
| SKYTROFA | Austria, Estonia, Croatia, Ireland, Italy, Lithuania, Poland, United States |
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