Ngenla

/ Pfizer

Treatment should be initiated and monitored by physicians who are qualified and experienced in the diagnosis and management of paediatric patients with growth hormone deficiency (GHD).
The recommended dose is 0.66 mg/kg body weight administered once weekly by subcutaneous injection.
When doses higher than 30 mg are needed (i.e. bodyweight > 45 kg), two injections have to be administered.
See prescribing information for full details.

Treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone.

* Hypersensitivity to somatrogon or to any of the excipients
* Must not be used when there is any evidence of activity of a tumour based on experience with daily growth hormone medicinal products. Intracranial tumours must be inactive and antitumour therapy must be completed prior to starting growth hormone (GH) therapy. Treatment should be discontinued if there is evidence of tumour growth.
* Must not be used for growth promotion in children with closed epiphyses.
* Must not be used for Patients with acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions.

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.
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. Patients should be monitored for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism.
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.
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.
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. 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. In female patients on oral oestrogen-containing therapy, a higher dose of somatrogon may be required to achieve the treatment goal.
See prescribing information for full details.

Very common: Headache, injection site reactions, pyrexia
Common: Anaemia, eosinophilia, hypothyroidism, conjunctivitis allergic, arthralgia, pain in extremity.
See prescribing information for full details.

No interactions studies in paediatrics have been performed.
Glucocorticoids: Concomitant treatment with glucocorticoids may inhibit the growth-promoting effects of somatrogon. Patients with adrenocorticotropic hormone (ACTH) deficiency should have their glucocorticoid replacement therapy carefully adjusted to avoid any inhibitory effect on growth. Growth hormone decreases the conversion of cortisone to cortisol and may unmask previously undiscovered central hypoadrenalism or render low glucocorticoid replacement doses ineffective.
Insulin and hypoglycaemic medicinal products: In patients with diabetes mellitus requiring medicinal product therapy, the dose of insulin and/or oral/injectable hypoglycaemic medicinal products may require adjustment when somatrogon therapy is initiated.
Thyroid medicinal products: Treatment with daily growth hormone may unmask previously undiagnosed or subclinical central hypothyroidism. Thyroxine replacement therapy may need to be initiated or adjusted.
Oral oestrogen therapy: In female patients on oral oestrogen-containing therapy, a higher dose of somatrogon may be required to achieve the treatment goal.
Cytochrome P450 metabolised products: The clearance of compounds metabolised by CYP3A4 (e.g. sex steroids, corticosteroids, anticonvulsants and ciclosporin) may be increased and could result in lower exposure of these compounds.
See prescribing information for full details.

Pregnancy: There are no data from the use of somatrogon in pregnant women
Lactation: It is unknown whether somatrogon/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from somatrogon therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Single doses of somatrogon higher than 0.66 mg/kg/week have not been studied.
Based on experience with daily growth hormone medicinal products, short-term overdose could lead initially to hypoglycaemia and subsequently to hyperglycaemia. Long-term overdose could result in signs and symptoms of gigantism and/or acromegaly consistent with the effects of growth hormone excess. Treatment of overdose with somatrogon should consist of general supportive measures.