Special Warning : אזהרת שימוש

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.

Hypersensitivity

Serious systemic hypersensitivity reactions (e.g. anaphylaxis, angioedema) have been reported with daily growth hormone medicinal products. If a serious hypersensitivity reaction occurs, use of somatrogon should be immediately discontinued; patients should be treated promptly per standard of care and monitored until signs and symptoms resolve (see section 4.3).

Hypoadrenalism

Based on published data patients receiving daily growth hormone therapy who have or are at risk for pituitary hormone deficiency(s) may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of somatrogon treatment (see section 4.5). Patients should be monitored for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism (see section 4.5).

Thyroid function impairment

Growth hormone increases the extrathyroidal conversion of T4 to T3 and may unmask incipient hypothyroidism. Patients with pre-existing hypothyroidism should be treated accordingly prior to the initiation of treatment with somatrogon as indicated based on clinical evaluation. As hypothyroidism interferes with the response to growth hormone therapy, patients should have their thyroid function tested regularly and should receive replacement therapy with thyroid hormone when indicated (see sections 4.5 and 4.8).

Prader-Willi syndrome

Somatrogon has not been studied in patients with Prader-Willi syndrome. Somatrogon is not indicated for the long-term treatment of paediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome unless they also have a diagnosis of GHD. There have been reports of sudden death after initiating therapy with growth hormone in paediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea, or unidentified respiratory infection.

Glucose metabolism impairment

Treatment with growth hormone medicinal products may reduce insulin sensitivity and induce hyperglycaemia. Additional monitoring should be considered in patients treated with somatrogon who have glucose intolerance, or additional risk factors for diabetes. In patients treated with somatrogon who have diabetes mellitus, hypoglycaemic medicinal products might require adjustment (see section 4.5).

Neoplasm

In patients with previous malignant disease, special attention should be given to signs and symptoms of relapse. Patients with pre-existing tumours or growth hormone deficiency 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 somatropin after their first neoplasm. Intracranial tumours, in particular meningiomas, in patients treated with radiation to the head for their first neoplasm, were the most common of these second neoplasms.

Benign intracranial hypertension

Intracranial hypertension (IH) with papilledema, ataxia, visual changes, headache, nausea and/or vomiting has been reported in a small number of patients treated with growth hormone medicinal products. Funduscopic examination is recommended at the initiation of treatment and as clinically warranted. In patients with clinical or funduscopic evidence of IH, somatrogon should be temporarily discontinued. At present there is insufficient evidence to give specific advice on the continuation of growth hormone treatment in patients with resolved IH. If treatment with somatrogon is restarted, monitoring for signs and symptoms of IH is necessary.

Acute critical illness

In critically ill adult patients suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma or acute respiratory failure mortality was higher in patients treated with 5.3 mg or 8 mg somatropin daily (i.e. 37.1 – 56 mg/week) compared to patients receiving placebo, 42% vs. 19%. Based on this information, these types of patients should not be treated with somatrogon. As there is no information available on the safety of growth hormone substitution therapy in acutely critically ill patients, the benefits of continued somatrogon 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 somatrogon must be weighed against the potential risk involved.

Pancreatitis

Although rare in patients treated with growth hormone medicinal products, pancreatitis should be considered in somatrogon-treated patients who develop severe abdominal pain during treatment.

Scoliosis

Because somatrogon increases growth rate, signs of development or progression of scoliosis should be monitored during treatment.

Epiphyseal disorders

Epiphyseal disorders, including slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders or in patients undergoing rapid growth. Any paediatric patient with the onset of a limp or complaints of hip or knee pain during treatment should be carefully evaluated.

Oral oestrogen therapy

Oral oestrogen influences the IGF-1 response to growth hormone. If a female patient taking somatrogon begins or discontinues oral oestrogen containing therapy, IGF-1 value should be monitored to determine if the dose of growth hormone should be adjusted to maintain the serum IGF-1 levels within the normal range (see section 4.2). In female patients on oral oestrogen-containing therapy, a higher dose of somatrogon may be required to achieve the treatment goal (see section 4.5).

Excipients

Sodium content
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free.’

Metacresol
Myositis is a very rare adverse event that may be related to the preservative metacresol. In the case of myalgia or disproportionate pain at injection site, myositis should be considered and if confirmed, other growth hormone medicinal products without metacresol should be used.


Effects on Driving

4.7    Effects on ability to drive and use machines

Ngenla has no or negligible influence on the ability to drive and use machines.