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NutropinAq is a brand name for Somatropin (also known as Somatotropin). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Paediatric population - Long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion. - Long-term treatment of girls from 2 years old with growth failure associated with Turner syndrome. - Treatment of prepubertal children with growth failure associated with chronic renal…
Verbatim from this product's EMA label. Tap a section to expand.
Diagnosis and therapy with somatropin should be initiated and monitored by physicians who are appropriately qualified and experienced in the diagnosis and management of patients with the therapeutic indication of use. Posology 3 The NutropinAq dosage and administration schedule should be individualised for each patient.
035 mg/kg bodyweight given as a daily subcutaneous injection. Somatropin therapy should be continued in children and adolescents until their epiphysis are closed. 05 mg/kg bodyweight given as a daily subcutaneous injection. Somatropin therapy should be continued in children and adolescents until their epiphysis are closed.
05 mg/kg bodyweight given as a daily subcutaneous injection. Somatropin therapy should be continued in children and adolescents until their epiphysis are closed, or up to the time of renal transplantation. 3 mg are recommended, given as a daily subcutaneous injection.
The dose should be adjusted stepwise, controlled by serum Insulin-like Growth Factor-1 (IGF-I) values. 0 mg/day. In general, the lowest efficacious dose should be administered. In older or overweight patients, lower doses may be necessary.
Women may require higher doses than men, with men showing an increasing IGF-I sensitivity over time. This means that there is a risk that women, especially those on oral oestrogen therapy, are under- treated while men are over-treated.
Method of administration The solution for injection should be administered subcutaneously each day. The site of injection should be changed. Precaution to be taken before manipulating or administering the product NutropinAq is supplied as a multi-dose solution.
After removal from the refrigerator, if the solution is cloudy, the content must not be injected. Gently swirl. Do not shake vigorously as it could denature the protein. NutropinAq is intended for use only with the NutropinAq Pen. 6.
Summary of the safety profile The adverse reactions reported in both adults and children receiving Nutropin, NutropinAq, Nutropin Depot or Protropin (somatrem) are listed in the table below, based on experience from clinical trials all approved indications (642 patients) and post-marketing sources which included a surveillance survey (National Cooperative Growth Study [NCGS] in 35,344 patients).
5 % of patients from the NCGS have experienced drug related adverse reactions. The most frequently reported adverse reactions from the pivotal and supportive clinical trials were hypothyroidism, impaired glucose tolerance, headache, hypertonia, arthralgia, myalgia, peripheral oedema, oedema, asthenia, injection site reaction and the presence of drug specific antibodies.
The most serious adverse reactions from the pivotal and supportive clinical trials were neoplasm and intracranial hypertension. 4). The majority of neoplasms reported were recurrence of previous neoplasms and second neoplasms. Intracranial hypertension was reported in the post-marketing surveillance survey.
It is typically associated with papilloedema, visual changes, headache, nausea, and/or vomiting and symptoms usually occur within eight weeks of initiation of therapy with NutropinAq. NutropinAq reduces insulin sensitivity; glucose tolerance impairment was reported in both the pivotal and supportive clinical trials and the post-marketing surveillance survey.
4). Injection site reactions such as haemorrhage, atrophy, urticaria and pruritus were reported in the pivotal and supportive clinical trials and/or the post-marketing surveillance survey. These events can be avoided by correct injection technique and rotation of injection sites.
A small percentage of patients may develop antibodies to the protein somatropin. The binding capacity 7 of growth hormone antibodies was lower than 2 mg/l in NutropinAq subjects tested, which has not been associated with adversely affected growth rate.
2). 4 Neoplasm In patients with previous malignant disease, special attention should be given to signs and symptoms of relapse. Patients with pre-existing tumors 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 tumors, in particular meningiomas, in patients treated with radiation to the head for their first neoplasm, were the most common of these second neoplasms.
Prader-Willi syndrome NutropinAq 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 growth hormone deficiency.
There have been reports of sleep apnoea and 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.
Acute critical illness The effects of growth hormone on recovery were studied in two placebo-controlled clinical trials involving 522 adult patients who were critically ill due to complications following open-heart or abdominal surgery, multiple accidental traumas, or who were having acute respiratory failure.
9 % vs. 3 - 8 mg/day) compared to those receiving placebo. The safety of continuing somatropin treatment in patients with acute critical illness in intensive care units due to complications following open-heart or abdominal surgery, multiple accidental trauma or acute respiratory failure receiving replacement doses for approved indications has not been established.
1. Somatropin should not be used for growth promotion in patients with closed epiphyses. Somatropin must not be used when there is any evidence of activity of a tumour. Intracranial tumours must be inactive and antitumour therapy must be completed prior to starting GH therapy.
Treatment should be discontinued if there is evidence of tumour growth. Growth hormone should not be initiated to treat patients with acute critical illness due to complications following open-heart or abdominal surgery, multiple accidental traumas or to treat patients having acute respiratory failure.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Somatropin in European Union.
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Tabulated summary of adverse reactions Table 1 contains very common (≥ 1/10), common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10,000, < 1/1,000) adverse reactions which occurred in clinical trials and a post-marketing surveillance survey.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Other adverse reactions have been identified during post approval use of NutropinAq. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency.
System Organ Class Reactions observed in Pivotal and Supportive Clinical Trials (in 642 patients) Reactions observed from the post marketing environment Neoplasms benign, malignant and unspecified (including cysts and polyps) Uncommon: Neoplasm malignant, neoplasm benign Rare: Neoplasm malignant recurrence, melanocytic naevus Blood and lymphatic system disorders Uncommon: Anaemia Endocrine disorders Common: Hypothyroidism Rare: Hypothyroidism Metabolism and nutrition disorders Common: Glucose tolerance impaired Uncommon: Hypoglycaemia, hyperphosphatemia Rare: Diabetes mellitus, hyperglycaemia, hypoglycaemia, glucose tolerance impaired Psychiatric disorders Uncommon: Personality disorder Rare: Abnormal behaviour, depression, insomnia Nervous system disorders Common: Headache, hypertonia, Uncommon: Carpal tunnel syndrome, somnolence, nystagmus Uncommon: Headache Rare: Benign intracranial hypertension, intracranial pressure increased, migraine, carpal tunnel syndrome, paraesthesia, dizziness Eye disorders Uncommon: Papilloedema, diplopia Rare: Papilloedema, vision blurred Ear and labyrinth disorders Uncommon: Vertigo Cardiac disorders Uncommon: Tachycardia Vascular disorders Uncommon: Hypertension Rare: Hypertension Respiratory thoracic and mediastinal disorders Rare: Tonsillar hypertrophy Uncommon: Adenoidal hypertrophy Gastrointestinal disorders Uncommon: Abdominal pain, vomiting, nausea, flatulence Rare: Abdominal pain, diarrhoea, nausea, vomiting Skin and subcutaneous tissue disorders Uncommon: Exfoliative dermatitis, skin atrophy, skin hypertrophy, hirsutism, lipodystrophy, urticaria Rare: Generalised pruritus, urticaria, rash Musculoskeletal and connective tissue disorders Very common in adults, common in children: Arthralgia, myalgia Uncommon: Muscle atrophy, bone pain Uncommon: Slipped capital femoral epiphysis, scoliosis progression, arthralgia Rare: Bone development abnormal, osteochondrosis, muscular weakness, pain in extremity Renal and urinary disorders Uncommon: Urinary incontinence, pollakiuria, polyuria, urine abnormality 8 Reproductive system and breast disorders Uncommon: Uterine haemorrhage, genital discharge Uncommon: Gynaecomastia General disorders and administration site conditions Very common in adults, common in children: Peripheral oedema, oedema Common: Asthenia, injection site reaction Uncommon: Injection site haemorrhage, injection site atrophy, injection site mass, hypertrophy Uncommon: Peripheral oedema, oedema, injection site reaction (irritation, pain) Rare: Asthenia, face oedema, fatigue, irritability, pain, pyrexia, injection site reaction (haemorrhage, haematoma, atrophy, urticaria, pruritus, swelling, erythema) Investigations Common: Drug specific antibody present Rare: Blood glucose increased, weight increased Description of selected adverse reactions Neoplasm There is a risk of neoplasia due to treatment with GH.
g. secondary to intracranial lesion), associated co- morbidities and treatment(s) undertaken. NutropinAq therapy must not be initiated when […]
Therefore, the benefit-risk assessment for continuing treatment should be performed carefully. Chronic renal insufficiency Patients with growth hormone failure secondary to CRI should be examined periodically for evidence of progression of renal osteodystrophy.
Slipped capital femoral epiphyses and aseptic necrosis of the femoral head may be seen in children with advanced renal osteodystrophy and in growth hormone deficiency, and it is uncertain whether these problems are affected by GH therapy.
Slipped capital femoral epiphysis In patients with endocrine disorders, including growth hormone deficiency, slipped epiphyses of the hip may occur more frequently than in the general population. A patient treated with somatropin who develops a limp or complains of hip or knee pain should be evaluated by a physician.
Scoliosis Scoliosis may progress in any child during rapid growth. Signs of scoliosis should be monitored during treatment. However, growth hormone treatment has not been shown to increase the incidence or severity of scoliosis. Glycaemic control Because somatropin may reduce insulin sensitivity, patients should be monitored for evidence of glucose intolerance.
For patients with diabetes mellitus, the insulin dose may require adjustment after NutropinAq therapy is instituted. Patients with diabetes or glucose intolerance should be monitored closely during somatropin therapy. Somatropin therapy is not indicated in diabetic patients with active proliferative or severe non-proliferative retinopathy.
Intracranial hypertension Intracranial hypertension with papilloedema, visual changes, headache, nausea and/or vomiting has been reported in a small number of patients treated with somatropin. Symptoms usually occur within 5 the first eight weeks of the initiation of NutropinAq therapy.
In all reported cases, intracranial hypertension-associated signs and symptoms resolved after reduction of the somatropin dose or termination of the therapy. Funduscopic examination is recommended at the initiation and periodically during the course of treatment.
Hypothyroidism Hypothyroidism may develop during treatment with somatropin, and untreated hypothyroidism may prevent optimal response to NutropinAq. Therefore, patients should have periodic thyroid function tests and should be treated with thyroid hormone when indicated.
Patients with severe hypothyroidism should be treated accordingly prior to the start of NutropinAq therapy. Renal transplantation Since somatropin therapy following renal transplantation has not been adequately tested, NutropinAq treatment should be terminated after that surgery.
Glucocorticoids use Concomitant treatment with glucocorticoids inhibits the growth-promoting effects of NutropinAq. Patients with ACTH deficiency should have their glucocorticoid replacement therapy carefully adjusted to avoid any inhibitory effect on growth.
The use of NutropinAq in patients with chronic renal insufficiency receiving glucocorticoid therapy has not been evaluated. Leukaemia Leukaemia has been reported in a small number of growth hormone deficient patients treated with growth hormone.
A causal relationship to somatropin therapy has not been established. Pancreatitis Although rare, pancreatitis should be considered in somatropin-treated patients who develop abdominal pain, especially in children. Use with oral oestrogen therapy If a woman taking NutropinAq begins oral oestrogen therapy, the dose of NutropinAq may need to be increased to maintain the serum IGF-1 levels within the normal age appropriate range.
5). e. essentially “sodium- free‟. Traceability In order to improve the traceability of biological medicinal products, the […]