Treatment Burden of Weekly Somatrogon vs Daily Somatropin in Children With Growth Hormone Deficiency: A Randomized Study
However, there is no evidence of an increased risk of leukaemia without predisposition factors, such as radiation to the brain or head. Children with growth hormone deficiency respond very well to somatropin and may be able to reach a relatively normal adult height. The recommendations in this guidance represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take this guidance fully into account, alongside the individual needs, preferences and values of their patients. † Reported in growth hormone deficient children treated with somatropin, but the incidence appears to be similar to that in children without growth hormone deficiency.
- Diagnosis and therapy with GENOTROPIN 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.
- Treatment should be discontinued if there is evidence of tumour growth.
- If on repeated measurements IGF-I levels exceed +2 SD compared to references for age and pubertal status, the IGF-I / IGFBP-3 ratio could be taken into account to consider dose adjustment.
- However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposition factors.
In all patients developing acute critical illness, the benefit of treatment must be weighed against the potential risk. Discontinue treatment if the height velocity is less than 2cm/year and bone age is greater than 14 years (girls) or 16 years (boys) (i.e. corresponding to the closure of the epiphyseal plates). Somatropin treatment should be started and monitored by a child health specialist with expertise in managing growth hormone disorders in children (paediatric endocrinologist). Some people with restricted growth (dwarfism) may be able to have growth hormone treatment or leg-lengthening surgery. 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.
somatropin (Saizen)
Sleep apnoea should be assessed before onset of growth hormone treatment by recognised methods such as polysomnography or overnight oxymetry, and monitored if sleep apnoea is suspected. The two main uses for the product are to treat Growth Hormone Deficiency (GHD) in children and girls with Turner’s syndrome. Restricted growth or well-being due to these conditions can be successfully treated with supplements of ZOMACTON, a product with a good safety profile. Department of Health and Social Care (DHSC) has issued a medicine supply notification for the Somatropin (Genotropin® MiniQuick) 0.6mg and 1.4mg powder and solvent for solution for injection pre-filled disposable devices.
- Whereas the peripheral thyroid hormone levels have remained within the reference ranges in the majority of healthy subjects, hypothyroidism theoretically may develop in subjects with subclinical hypothyroidism.
- Intracranial tumours must be inactive and antitumour therapy must be completed prior to starting growth hormone therapy.
- Concomitant treatment with glucocorticoids inhibits the growth-promoting effects of somatropin containing products.
- † Reported in growth hormone deficient children treated with somatropin, but the incidence appears to be similar to that in children without growth hormone deficiency.
- At present there is insufficient evidence to give specific advice on the continuation of growth hormone treatment in patients with resolved intracranial hypertension.
- Store in a refrigerator (2°C – 8°C), or for a maximum of 1 month at or below 25°C.
The binding capacity of these antibodies is low and there is no effect on growth rate. Testing for antibodies to somatropin should be carried out in any patient with otherwise unexplained lack of response. For patients with diabetes mellitus, the insulin dose may require adjustment after somatropin therapy is instituted. Patients with diabetes, glucose intolerance, or additional risk factors for diabetes should be monitored closely during somatropin therapy.
Psychological therapy
If a girl or woman is diagnosed with Turner syndrome, the following areas may be monitored throughout her life. Over time, this bone gets stronger until it’s able to support your weight. We found nothing new that affects the recommendations in this guidance. The GENOTROPIN Pens are colour coded, and must be used with the matching colour coded GENOTROPIN two-chamber cartridge to give the correct dose. The GENOTROPIN Pen 5.3 (blue) must be used with GENOTROPIN 5.3 mg cartridge (blue).
In patients with increased risk for diabetes mellitus (e.g. familial history of diabetes, obesity, severe insulin resistance, acanthosis nigricans) oral glucose tolerance testing (OGTT) should be performed. In case of severe or recurrent headache, visual problems, nausea and/or vomiting, a funduscopy 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 give specific advice on the continuation of growth hormone treatment in patients with resolved intracranial hypertension.
In growth hormone deficiency secondary to treatment of malignant disease, it is recommended to pay attention to signs of relapse of the malignancy. 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. In clinical trials in short children born SGA doses of 0.033 and 0.067 mg/kg body weight per day have been used for treatment until final height. Literature data from untreated SGA children without early spontaneous catch-up suggest a late growth of 0.5 SDS.
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Slipped capital femoral epiphysis occurs more frequently in case of endocrine disorders and Legg-Calve-Perthes is more frequent in case of short stature. But, it is unknown if these 2 pathologies are more frequent or not while treated with somatropin. Their diagnosis should be considered in a child with a discomfort or pain in the hip or knee. Somatropin has been reported to reduce serum cortisol levels, possibly by affecting carrier proteins or by increased hepatic clearance.
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at /yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. In the post-marketing experience rare cases of sudden death have been reported in patients affected by Prader-Willi syndrome treated with somatropin, although no causal relationship has been demonstrated. Before initiation of treatment with somatropin in patients with Prader-Willi syndrome, signs for upper airway obstruction, sleep apnoea, or respiratory infections should be assessed. As with all somatropin containing products, a small percentage of patients may develop antibodies to GENOTROPIN. GENOTROPIN has given rise to the formation of antibodies in approximately 1% of patients.