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Ngenla is a brand name for Somatrogon. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ngenla is indicated for the treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone.
Verbatim from this product's EMA label. Tap a section to expand.
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). 66 mg/kg body weight administered once weekly by subcutaneous injection.
3 Each pre-filled pen is capable of setting and delivering the dose prescribed by the physician. Dose may be rounded up or down based on the physician’s expert knowledge of the individual patient needs. e. bodyweight > 45 kg), two injections have to be administered.
66 mg/kg/week on the day following their last daily injection. Dose titration Somatrogon dose may be adjusted as necessary, based on growth velocity, adverse reactions, body weight and serum insulin-like growth factor 1 (IGF-1) concentrations.
When monitoring for IGF-1, samples should always be drawn 4 days after the prior dose. e. between -2 and +2 (preferably close to 0 SDS). In patients whose serum IGF-1 concentrations exceed the mean reference value for their age and sex by more than 2 SDS, the dose of somatrogon should be reduced by 15%.
More than one dose reduction may be required in some patients. Treatment evaluation and discontinuation Evaluation of efficacy and safety should be considered at approximately 6 to 12 month intervals and may be assessed by evaluating auxological parameters, biochemistry (IGF-1, hormones, glucose levels) and pubertal status.
Routine monitoring of serum IGF-1 SDS levels throughout the course of treatment is recommended. More frequent evaluations should be considered during puberty. 3). e. an annualised height velocity < 2 cm/year or a bone age > 14 years in girls or > 16 years in boys.
Missed dose Patients should maintain their regular dosing day. If a dose is missed, somatrogon should be administered as soon as possible within 3 days after the missed dose, and then the usual once weekly dosing schedule should be resumed.
If more than 3 days have passed, the missed dose should be skipped and the next dose should be administered on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule. Changing the dosing day The day of weekly administration can be changed if necessary as long as the time between two doses is at least 3 days.
2%). 1). 66 mg/kg/week). Table 1 presents the adverse reactions for somatrogon within the system organ class (SOC). The adverse reactions listed in the table below are presented by SOC and frequency categories, defined using the following convention: 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) or frequency not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. Table 1. 2 a Injection site reactions include the following: injection site pain, erythema, pruritus, swelling, induration, bruising, haemorrhage, warmth, hypertrophy, inflammation, deformation, urticaria.
Description of selected adverse reactions Injection site reaction In the phase 3 clinical study, reporting of ISRs was actively solicited during the course of the study. In the majority of cases, local ISRs tended to be transient, occurred mainly in the first 6 months of treatment and were mild in severity; ISRs had a mean onset on the day of the injection and a mean duration of < 1 day.
2% of patients administered daily injections of somatropin. In the long-term OLE of the clinical phase 3 study, local ISRs were similar in nature and severity, and reported early in subjects switching from somatropin to somatrogon treatment.
3% of patients originally treated with somatrogon in the main study and continuing treatment in the OLE portion of the study, and likewise, 37% were reported among patients originally treated with somatropin that were switched in the OLE portion of the study to treatment with somatrogon.
1%) tested positive for anti-drug antibodies (ADAs). There were no clinical or safety effects observed with the formation of antibodies. 4). 4). 4), paraesthesia. • Musculoskeletal, connective tissue, and bone disorders: myalgia. • Reproductive system and breast disorders: gynaecomastia.
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. g. anaphylaxis, angioedema) have been reported with daily growth hormone medicinal products.
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.
5). 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.
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.
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 6 disease process.
1. Somatrogon 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.
4). Somatrogon must not be used for growth promotion in children with closed epiphyses. 4). 5
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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After selecting a new dosing day, the once weekly dosing should be continued. Special populations Elderly The safety and efficacy of somatrogon in patients over the age of 65 years have not been established. No data are available. Renal impairment Somatrogon has not been studied in patients with renal impairment.
No dose recommendation can be made. 4 Hepatic impairment Somatrogon has not been studied in patients with hepatic impairment. No dose recommendation can be made. Paediatric population The safety and efficacy of somatrogon in neonates, infants and children less than 3 years of age have not yet been established.
No data are available. Method of administration Somatrogon is administered by subcutaneous injection. Somatrogon is to be injected in the abdomen, thighs, buttocks or upper arms. 8). Injections to the upper arms and buttocks should be given by the caregiver.
The patient and caregiver should receive training to ensure understanding of the administration procedure to support self-administration. If more than one injection is required to deliver a complete dose, each injection should be administered at a different injection site to prevent lipoatrophy.
Somatrogon is to be administered once weekly, on the same day each week, at any time of the day. 01 mL). 01 mL). 6 and at the end of the package leaflet.
• Skin and subcutaneous tissue disorders: skin rash, urticaria and pruritus. • General disorders and administration site conditions: peripheral oedema, facial oedema. 4). 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 10
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. e. 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. 2). In female patients on oral oestrogen-containing therapy, a higher […]