SKYTROFA

Method of administration Each injection should be administered subcutaneously once-weekly in the abdomen, buttock or thigh. The site of administration should be varied to prevent lipoatrophy. Lonapegsomatropin is intended to be administered after reconstitution of the powder for solution for injection with the enclosed solvent.

Lonapegsomatropin should be administered by means of the Skytrofa Auto-Injector. The patient and caregiver should receive training to ensure understanding of the administration procedure by means of the device in order to be allowed to (self)-inject lonapegsomatropin.

6). 6 and the instructions included at the end of the package leaflet.

6%). In general, these reactions tended to be transient and severity was mild to moderate. Tabulated list of adverse reactions Table 3 below shows adverse reactions which occurred during lonapegsomatropin treatment. The adverse reactions are ranked under headings of MedDRA system organ class and frequency using the following terminology: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), and frequency not known (cannot be estimated from the available data).

Table 3 Frequency of adverse reactions in clinical trials System organ class Very common Common Uncommon Immune system disorders Anaphylactic reactionb Endocrine disorders Secondary hypothyroidism Secondary adrenocortical insufficiency Nervous system disorders Headache Musculoskeletal and connective tissue disorders Arthralgia Scoliosis Arthritis Growing pains Reproductive system and breast disorders Gynaecomastia General disorders and administration site conditions Injection site reactionsa a Injection site reactions include hyperaemia, injection site atrophy, injection site pain, injection site urticaria, and localised oedema.

The injection site reactions observed with lonapegsomatropin were generally mild and transient. 4). Description of selected adverse reactions Immunogenicity Patients may develop antibodies to lonapegsomatropin. 3%) and no patients had neutralising antibodies.

No apparent correlation of anti-lonapegsomatropin binding antibodies to adverse events or loss of efficacy was observed. 4). Adverse reactions related to growth hormone pharmacological class In addition to the above-mentioned adverse drug reactions, those presented below have been reported with other growth hormone-containing products.

Frequencies of these adverse events cannot be estimated from the available data (unless otherwise indicated). 4). 4). 4), paraesthesia. • Musculoskeletal and connective tissue disorders: myalgia. • Reproductive system and breast disorders: gynaecomastia (frequency: uncommon).

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. e. 1 – 56 mg/week) compared to patients receiving placebo, 42% vs.

19%. As there is no information available on the safety of growth hormone substitution therapy in acutely critically ill patients, the benefits of continued lonapegsomatropin treatment in this situation should be weighed against the potential risks involved.

In all patients developing other or similar acute critical illness, the possible benefit of treatment with lonapegsomatropin must be weighed against the potential risk involved. Neoplasm In patients with previous malignant disease, special attention should be given to signs and symptoms of relapse.

Patients with pre-existing tumours or GHD secondary to an intracranial lesion should be examined routinely for progression or recurrence of the underlying disease process. In childhood cancer survivors, an increased risk of a second neoplasm has been reported in patients treated with growth hormone after their first neoplasm.

Intracranial tumours, in particular meningiomas, were the most common form of a second neoplasm reported in patients treated with radiation to the head for their first neoplasm. Hypersensitivity Anaphylactic reactions including angioedema have been reported with the use of lonapegsomatropin.

Inform patients and caregivers that such reactions can occur, particularly after first dose, and that prompt medical attention should be sought if a sudden serious hypersensitivity reaction occurs. 3). Benign intracranial hypertension In case of severe or recurrent ataxia, headache, visual problems, nausea and/or vomiting, a funduscopy for papilloedema is recommended.

If papilloedema is confirmed, a diagnosis of benign intracranial hypertension should be considered and, if appropriate, growth hormone treatment should be discontinued. At present there is insufficient evidence to give specific advice on the continuation of growth hormone treatment in patients with resolved intracranial hypertension.

4). 4). Intracranial tumours must be inactive and anti-tumour therapy must be completed prior to starting growth hormone therapy. Treatment should be discontinued if there is evidence of tumour growth. 4). Lonapegsomatropin must not be used for growth promotion in children with closed epiphyses.