Loading…
HUMATROPE 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 Patients Humatrope is indicated for the long-term treatment of children who have growth failure due to an inadequate secretion of normal endogenous growth hormone. Humatrope is also indicated for the treatment of short stature in children with Turner Syndrome, confirmed by chromosome analysis. Humatrope is…
Verbatim from this product's MHRA label. Tap a section to expand.
035 mg/kg of body weight per day by subcutaneous injection. 0 mg/m2 body surface area per day. 30 mg/day. 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-I concentrations.
Total daily dose usually does not exceed 1 mg. IGF-I concentrations should be maintained below the upper limit of the age-specific normal range. The minimum effective dose should be used and dose requirements may decline with increasing age.
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.
8). 050 mg/kg of body weight per day given as a subcutaneous injection to be administered preferably in the evening. 4 mg/m2 per day. 050 mg/kg of body weight per day given as a subcutaneous injection. 050 mg/kg of body weight per day given as subcutaneous injection.
1). 0 SDS. Treatment should be discontinued if height velocity is <2cm/year and, if confirmation is required, bone age is >14 years (girls) or >16 years (boys), corresponding to closure of epiphyseal growth plates. Method of administration Humatrope is administered by subcutaneous injection after reconstitution The subcutaneous injection sites should be varied in order to avoid lipoatrophy.
6.
The following table of undesirable effects and frequencies is based on clinical trial and post- marketing spontaneous reports. 1 % adults Paediatric patients In clinical trials with growth hormone deficient patients approximately 2 % of the patients developed antibodies to growth hormone.
In trials in Turner Syndrome where higher doses were used, up to 8 % of patients developed antibodies to growth hormone. The binding capacity of these antibodies was low and growth rate was not affected adversely. Testing for antibodies to growth hormone should be carried out in any patient who fails to respond to therapy.
A mild and transient oedema was observed early during the course of treatment. Leukaemia has been reported in a small number of children who have been treated with growth hormone. However there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposing factors.
Adult patients In patients with adult onset growth hormone deficiency, oedema, muscle pain and joint pain and disorder, were reported early in therapy and tended to be transient. Adult patients treated with growth hormone, following diagnosis of growth hormone deficiency in childhood, reported side effects less frequently than those with adult onset growth hormone deficiency.
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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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. 2). Previous paediatric 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.
Diagnosis and therapy with Humatrope should be initiated and monitored by physicians who are appropriately qualified and experienced in the diagnosis and management of patients with growth hormone deficiency. There is so far 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. 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. 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.
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. Growth hormone increases the extrathyroidal conversion of T4 to T3 and may as such unmask incipient hypothyroidism.
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.
Humatrope should not be reconstituted with the supplied solvent for patients with a known sensitivity to either metacresol or glycerol. Humatrope should not be used for growth promotion in children with closed epiphyses. 4). 1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Somatropin in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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. For paediatric patients, 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. Before instituting treatment with somatropin for growth retardation secondary to chronic renal insufficiency, patients 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. 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 trauma, or who were having acute respiratory failure.
9 % vs. 3-8 mg/day) compared to those receiving placebo. The safety of continuing growth hormone in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. Therefore, the potential benefit of treatment continuation in patients having acute critical illnesses should be weighed against the potential risks.
If a woman taking somatropin begins oral oestrogen therapy, the dose of somatropin may need to be increased to maintain the serum IGF-1 levels within the normal age-appropriate range. 5). If a change of the route of oestrogen administration (oral to transdermal or vice-versa) is made, growth hormone should be newly titrated.
An increasing sensitivity to growth hormone (expressed as change in serum IGF-I per growth hormone dose) over time may be observed, particularly in men. Introduction of somatropin treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations.
In patients treated with somatropin, previously undiagnosed central (secondary) hypoadrenalism may be unmasked and glucocorticoid replacement may be required. 5). Unless patients with Prader-Willi syndrome also have a diagnosis of growth hormone deficiency, Humatrope is not indicated for the treatment of patients who have growth failure due to genetically confirmed Prader-Willi syndrome.
There have been reports of sleep apnoea and sudden death after initiating therapy with growth hormone 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.
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 somatropin therapy is instituted.
Patients with diabetes or glucose intolerance should be monitored closely during somatropin therapy. Elderly patients (age ≥65 years) are more sensitive to […]