SKYTROFA Powder and solvent for solution for injection (2022)
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Περιεχόμενα
1. Name of the medicinal product
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 ...
2. Qualitative and quantitative composition
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 ...
3. Pharmaceutical form
Powder and solvent for solution for injection (injection). White to off-white powder. The solvent is a clear and colourless solution.
4.1. Therapeutic indications
Growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency [GHD]).
4.2. Posology and method of administration
Treatment should be initiated and monitored by physicians who are qualified and experienced in the diagnosis and management of paediatric patients with GHD. The amount and concentration of lonapegsomatropin ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Somatropin must not be used when there is any evidence of activity of a tumour (see section 4.4). Intracranial ...
4.4. Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Acute critical illness In critically ...
4.5. Interaction with other medicinal products and other forms of interaction
Glucocorticoid treatment Concomitant treatment with glucocorticoids inhibits the growth-promoting effects of lonapegsomatropin. Patients with adrenocorticotropic hormone (ACTH) deficiency should have their ...
4.6. Pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of lonapegsomatropin in pregnant women; published studies with short-acting somatropin use in pregnant women over several decades have not ...
4.7. Effects on ability to drive and use machines
Lonapegsomatropin has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of safety profile The most frequently reported adverse reactions in clinical trials with lonapegsomatropin were headache (11.1%), arthralgia (4.6%), secondary hypothyroidism (2.6%), and injection ...
4.9. Overdose
Symptoms Acute overdose could lead initially to hypoglycaemia and subsequently to hyperglycaemia. Long-term overdose could result in signs and symptoms of gigantism. Management Treatment is symptomatic ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Pituitary and hypothalamic hormones and analogues, somatropin and somatropin agonists <b>ATC Code:</b> H01AC09 Mechanism of action Lonapegsomatropin is a long-acting ...
5.2. Pharmacokinetic properties
The pharmacokinetics following administration of lonapegsomatropin was assessed after single dose in a total of 73 healthy adults in 2 trials. In addition, PK in paediatrics with GHD was evaluated based ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenicity. Reproductive toxicology studies performed in rats and histopathological ...
6.1. List of excipients
<u>Powder:</u> Succinic acid Trehalose dihydrate Trometamol <u>Solvent:</u> Water for injections
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
Unopened 3 years when stored in a refrigerator (2°C-8°C). Alternatively, Lonapegsomatropin Ascendis Pharma may be stored at temperatures ≤30°C for up to 6 months. Within the 6 months, the medicinal product ...
6.4. Special precautions for storage
Store in refrigerator (2°C-8°C). Do not freeze. Store in the original package in order to protect from light. For alternative storage conditions at temperatures ≤30°C, see section 6.3. For storage conditions ...
6.5. Nature and contents of container
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) ...
6.6. Special precautions for disposal and other handling
Handling If refrigerated, keep at room temperature for 15 minutes before use. Each Skytrofa dual-chamber cartridge containing the powder and solvent for solution for injection is for single-use only and ...
7. Marketing authorization holder
Ascendis Pharma Endocrinology Division A/S, Tuborg Boulevard 12, DK-2900 Hellerup, Denmark
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 11 January 2022
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