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Valtropin 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 (2 to 11 years old) and adolescents (12 to 18 years old) with growth failure due to an inadequate secretion of normal endogenous growth hormone. - Treatment of short stature in children with Turner syndrome, confirmed by chromosome analysis. - Treatment of growth…
Verbatim from this product's EMA label. Tap a section to expand.
Therapy with Valtropin should be initiated and monitored by physicians adequately experienced in the diagnosis and management of patients with growth hormone deficiency. Posology 2Medicinal product no longer authorised The dosage and administration schedule should be individualised for each patient.
035 mg/kg body weight per day. 050 mg/kg body weight per day, given as a subcutaneous injection. 050 mg/kg body weight per day, given as a subcutaneous injection. 30 mg/day, given as a subcutaneous injection. A lower starting dose may be necessary in older and obese patients.
This dose should be gradually increased according to individual patient requirements based on the clinical response and serum IGF-1 concentrations. Total daily dose usually does not exceed 1 mg. IGF-1 concentrations should be maintained below the upper limit of the age-specific normal range.
The minimum effective dose should be used. The dosage of somatropin should be decreased in cases of persistent oedema or severe paresthesia, in order to avoid the development of carpal tunnel syndrome. Experience of prolonged treatment (over 5 years) with somatropin in adults is limited.
Special populations Elderly Experience of somatropin treatment in patients above 60 years of age is limited. A lower starting dose may be necessary in older patients. Dose requirements may decline with increasing age. 4, but no recommendation on a posology can be made.
Hepatic impairment In patients with severe liver dysfunction a reduction of somatropin clearance has been noted. The clinical significance of this decrease is unknown. Method of administration Valtropin is administered by subcutaneous injection.
The injection sites should be varied in order to avoid lipo-atrophy. 6.
Summary of the safety profile The most common frequent adverse reactions are associated with the injection site, of endocrine nature, and headache, paresthesia and joint pain and disorder (arthralgia) in adults. During clinical studies 128 children (98 children with growth hormone deficiency and 30 with Turner syndrome) were exposed to Valtropin.
The safety profile of Valtropin observed in these clinical studies was consistent with that reported with the reference medicinal product used in these studies and other somatropin containing medicinal products. The following adverse reactions and their frequencies have been observed under treatment with somatropin based on published information: 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), not known (cannot be estimated from the available data), including isolated reports Tabulated summary of adverse reactions Neoplasms benign, malignant and unspecified (including cysts and polyps) Uncommon: Neoplasm malignant, neoplasm Blood and lymphatic system disorders Uncommon: Anaemia Immune system disorders Common: Antibody building Not known: Single case of acute hypersensitivity involving urticaria and pruritus Endocrine disorders Common: Hypothyroidism Metabolism and nutrition disorders Common: Glucose tolerance impaired Common: Mild hyperglycaemia (1% in children; 6Medicinal product no longer authorised 1% - 10% in adults) Uncommon: Hypoglycaemia, hyperphosphatemia Rare: Diabetes mellitus Not known: Insulin resistance Psychiatric disorders Uncommon: Personality disorder Nervous system disorders Very common: Headache in adults Very common: Paresthesia in adults Common: Hypertonia Common: Insomnia in adults Common: Carpal tunnel syndrome in adults Uncommon: Carpal tunnel syndrome in children Uncommon: Nystagmus Rare: Neuropathy, intracranial pressure increased Rare: Benign intracranial hypertension Rare: Paresthesia in children Very rare: Insomnia in children Eye disorders Uncommon: Papilloedema, diplopia Ear and labyrinth disorders Uncommon: Vertigo Cardiac disorders Common: Hypertension in adults Uncommon: Tachycardia Rare: Hypertension in children Respiratory, thoracic and mediastinal disorders Common: Dyspnoea in adults Common: Sleep apnoea in adults Gastrointestinal disorders Uncommon: Vomiting, abdominal pain, flatulence, nausea Rare: Diarrhoea Skin and subcutaneous tissue disorders Uncommon: Lipodystrophy, skin atrophy, exfoliative dermatitis, urticaria, hirsutism, skin hypertrophy Musculoskeletal and connective tissue disorders Very common: Arthralgia in adults Common: Arthralgia in children Common: Myalgia Uncommon: Muscle atrophy, bone pain Renal and urinary disorders Uncommon: Urinary incontinence, haematuria, polyuria, urine frequency/pollakiuria, urine abnormality Reproductive system and breast disorders Uncommon: Genital discharge Uncommon: Gynaecomastia in adults Very rare: Gynaecomastia in children General disorders and administration site conditions Very common: Oedema, peripheral oedema in adults Common: Oedema, peripheral oedema in children Common: Injection site reactions, asthenia Uncommon: Injection site atrophy, injection site haemorrhage, injection site mass, hypertrophy, weakness in children Investigations Rare: Renal function test abnormal Description of selected adverse reactions 7Medicinal product no longer authorised In a clinical study with Valtropin, 3% of children with growth hormone deficiency developed antibodies to somatropin.
2). Pituitary There is no evidence to suspect that growth hormone replacement influences the recurrence rate or regrowth of intracranial neoplasms, but standard clinical practice requires regular pituitary imaging in patients with a history of pituitary pathology.
A baseline scan is recommended in these patients before instituting growth hormone replacement therapy. Tumour control If the patient has had a brain tumour, the patient should be re-examined frequently to make sure that the tumour has not come back.
In childhood cancer survivors, a higher risk of a second neoplasm (benign or malignant) has been reported in patients treated with somatropin. Intracranial tumours, in particular, were the most common of these second neoplasms. Intracranial hypertension In cases of severe or recurrent headache, visual problems, nausea, and/or vomiting, a fundoscopy for papilloedema is recommended.
If papilloedema is confirmed, a diagnosis of benign intracranial hypertension should be considered and, if appropriate, the growth hormone treatment should be discontinued. At present, there is insufficient evidence to guide clinical decision making in patients with resolved intracranial hypertension.
If growth hormone treatment is restarted, careful monitoring for symptoms of intracranial hypertension is necessary. Insulin sensitivity Because human growth hormone may induce a state of insulin resistance, patients treated with somatropin should be monitored for evidence of glucose intolerance.
Thyroid function Growth hormone increases the extrathyroidal conversion of T4 to T3 and may, as such, unmask incipient hypothyroidism. Monitoring of thyroid function should therefore be conducted in all patients. In patients with hypopituitarism, standard replacement therapy must be closely monitored when somatropin therapy is administered.
Slipped capital epiphyse Patients with endocrine disorders, including growth hormone deficiency, may develop slipped capital epiphyses more frequently. Any child with the onset of a limp during growth hormone therapy should be evaluated.
g. 4). - 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.
- Valtropin should not be used for growth promotion in children with closed epiphyses. - Patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or patients having acute respiratory failure.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The binding capacity of these antibodies was low and there was no effect on growth rate. Testing for antibodies to somatropin should be carried out in any patient who fails to respond to therapy. Anti-host cell protein (anti-S. cerevisiae) antibodies were uncommon in patients treated with Valtropin.
The generation of such antibodies with low binding capacity is unlikely to be clinically relevant. In contrast to bacteria (E. coli), yeast has not been described to elicit adjuvant effects modifying the immunological response. Paediatric population Mild and transient oedema was observed early during the course of treatment with somatropin.
Adult patients In adult patients with adult-onset growth hormone deficiency, oedema, muscle pain, joint pain and disorders were reported early in therapy and tended to be transient.
Growth hormone deficiency after epiphyseal closure Subjects who had been treated with growth hormone during childhood, until final height was attained, should be re-evaluated for growth hormone deficiency after epiphyseal closure before replacement therapy is commenced at the doses recommended for adults.
Treatment after the end of growth in children 4Medicinal product no longer authorised For children, the treatment should be continued until the end of the growth has been reached. It is advisable not to exceed the recommended dosage in view of the potential risks of acromegaly, hyperglycaemia, and glucosuria.
Prader-Willi syndrome Valtropin is not indicated for the treatment of patients with growth failure due to 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 growth hormone therapy in 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.
Renal insufficiency Before instituting treatment with somatropin for growth retardation secondary to chronic renal insufficiency, children should have been followed for one year to verify growth disturbance. Conservative treatment for renal insufficiency (which includes control of acidosis, hyperparathyroidism, and nutritional status for one year prior to the treatment) should have been established and should be maintained during treatment.
Treatment with somatropin should be discontinued at the time of renal transplantation. Gender and dosing In order to reach the defined treatment goal, men may need lower growth hormone doses than women. Oral oestrogen administration increases the dose requirements in women.
An increasing sensitivity to growth hormone (expressed as change in IGF-1 per growth hormone dose) over time may be observed, particularly in men. The accuracy of the growth hormone dose should therefore be controlled every 6 months.
Turner syndrome Patients with Turner syndrome should be evaluated carefully for otitis media and other ear disorders since these patients have an increased risk of ear or hearing disorders. Pancreatitis in children Children treated with somatropin have an increased risk of developing pancreatitis compared to adults treated with somatropin.
Although rare, pancreatitis should be considered in somatropin-treated children who develop abdominal pain. Accidental intramuscular injection After accidental intramuscular injection, hypoglycaemia may appear. Any unwanted reaction should be followed.
No special treatment is recommended. Sensitivity to metacresol Valtropin should not be reconstituted with the supplied solvent for patients with a known sensitivity to metacresol. 3).