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Omnitrope 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: Infants, children and adolescents - Growth disturbance due to insufficient secretion of growth hormone (growth hormone deficiency, GHD). - Growth disturbance associated with Turner syndrome. - Growth disturbance associated with chronic renal insufficiency. - Growth disturbance (current height standard deviation score…
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 growth disorders. Posology Paediatric population The posology and administration schedule should be individualised.
0 mg/m2 body surface area per day is recommended. Even higher doses have been used. g. body composition, bone mass). e. standardized to average adult peak bone mass measured by dual energy X-ray absorptiometry taking into account sex and ethnicity) is one of the therapeutic objectives during the transition period.
For guidance on dosing see adult section below. 0 mg/m2 body surface area per day is recommended. 7 mg should not be exceeded. Treatment should not be used in paediatric patients with a growth velocity less than 1 cm per year and near closure of epiphyses.
4 mg/m2 body surface area per day is recommended. 4 mg/m2 body surface area per day) is recommended. Higher doses may be needed if growth velocity is too low. 4). 1). Treatment should be discontinued after the first year of treatment if the height velocity SDS is below + 1.
Treatment should be discontinued if height velocity is < 2 cm/year and, if confirmation is required, bone age is > 14 years (girls) or > 16 years (boys), corresponding to closure of the epiphyseal growth plates. 5 mg per day. The dose should be gradually increased or decreased according to individual patient requirements as determined by the IGF-I concentration.
3 mg per day. The dose should be gradually increased according to individual patient requirements as determined by the IGF-I concentration. In both cases treatment goal should be insulin-like growth factor (IGF-I) concentrations within 2 SDS from the age corrected mean.
Patients with normal IGF-I concentrations at the start of the treatment should be administered growth hormone up to an IGF-I level into the upper range of normal, not exceeding the 2 SDS. Clinical response and side effects may also be used as guidance for dose titration.
It is recognized that there are patients with GHD who do not normalize IGF-I levels despite a good clinical response, and thus do not require dose escalation. 0 mg per day. Women may require higher doses than men, with men showing an increasing IGF-I sensitivity over time.
a. Summary of the safety profile Patients with growth hormone deficiency are characterised by extracellular volume deficit. When treatment with somatropin is started this deficit is rapidly corrected. Adverse reactions related to fluid retention, such as peripheral oedema and arthralgia are very common; musculoskeletal stiffness, myalgia and paraesthesia are common.
In general these adverse reactions are mild to moderate, arise within the first months of treatment and subside spontaneously or with dose-reduction. The incidence of these adverse reactions is related to the administered dose, the age of patients, and possibly inversely related to the age of patients at the onset of growth hormone deficiency.
Omnitrope has given rise to the formation of antibodies in approximately 1% of the patients. 4. b. Tabulated list of adverse reactions Table 1 shows the adverse reactions ranked under headings of System Organ Class and frequency 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); not known (cannot be estimated from the available data) for each of the indicated conditions.
Table 1 System organ Class Very commo n (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10, 0 00 to <1/100 0) Very rare (<1/10,00 0) Not known (cannot be estimated from available data) Neoplasms benign, malignant, and unspecified (including cysts and polyps) (Children) Leukaemia† 10 System organ Class Very commo n (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10, 0 00 to <1/100 0) Very rare (<1/10,00 0) Not known (cannot be estimated from available data) Endocrine disorders Hypothyroidism ** Metabolism and nutrition disorders (Adults and Children) Type 2 diabetes mellitus Nervous system disorders (Adults) Paraesthesia* (Adults) Carpal tunnel syndrome (Children) Benign intracranial hypertension (Children) Paraesthesia * (Adults) Benign intracranial hypertension (Adults and Children) Headache Skin and subcutaneous tissue disorders (Children) Rash**, Pruritus**, Urticaria** (Adults) Rash**, Pruritus**, Urticaria** Musculoskele tal and connective tissue disorders (Adults) Arthralg ia * (Adults) Myalgia* (Adults) Musculoskele tal stiffness* (Children) Arthralgia* (Children) Myalgia* (Children) Musculoskeletal stiffness* Reproductive system and breast disorders (Adults and Children) Gynaecomas tia General disorders and administratio n site conditions (Adults) Oedema peripher al * (Children) Injection-site reaction$ (Children) Oedema peripheral* (Adults and Children) Face oedema* (Adults) Injection-site reaction$ Investigations (Adults and Children) Blood cortisol decreased‡ *In general, these adverse effects are mild to moderate, arise within the first months of treatment, and subside spontaneously or with dose-reduction.
2). 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. Hypoadrenalism 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). Use with oral oestrogen therapy 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). Insulin sensitivity Somatropin may reduce insulin sensitivity. 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.
Thyroid function Growth hormone increases the extrathyroidal conversion of T4 to T3 which may result in a reduction in serum T4 and an increase in serum T3 concentrations. Whereas the peripheral thyroid hormone levels have remained within the reference ranges for healthy subjects, hypothyroidism theoretically may develop in subjects with subclinical hypothyroidism.
Consequently monitoring of thyroid function should therefore be conducted in all patients. In patients with hypopituitarism on standard replacement therapy, the potential effect of growth hormone treatment on thyroid function must be closely monitored Neoplasms 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.
1. Somatropin must not be used when there is any evidence of activity of a tumour. Intracranial tumours must be inactive and anti-tumour therapy must be completed prior to starting GH therapy. Treatment should be discontinued if there is evidence of tumour growth.
Somatropin must not be used for growth promotion in children with closed epiphyses. 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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This means that there is a risk that women, especially those on oral oestrogen replacement are under-treated while men are over-treated. The accuracy of the growth hormone dose should therefore be controlled every 6 months. As normal physiological growth hormone production decreases with age, dose requirements may be reduced.
2 mg per day and should be slowly increased according to individual patient requirements. The minimum effective dose should be used. 5 mg per day. Method of administration The injection should be given subcutaneously and the site varied to prevent lipoatrophy.
6.
The incidence of these adverse effects is related to the administered dose, the age of the patients, and possibly inversely related to the age of the patients at the onset of growth hormone deficiency. **Adverse drug reaction (ADR) identified post-marketing.
$ Transient injection site reactions in children have been reported. 11 ‡ Clinical significance is unknown † Reported in growth hormone deficient children treated with somatropin, but the incidence appears to be similar to that in children without growth hormone deficiency.
c. Description of selected adverse reactions Reduced serum cortisol levels Somatropin has been reported to reduce serum cortisol levels, possibly by affecting carrier proteins or by increased hepatic clearance. The clinical relevance of these findings may be limited.
Nevertheless, corticosteroid replacement therapy should be optimised before initiation of therapy. Prader-Willi syndrome 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.
Leukaemia Cases of leukaemia (rare or very rare) have been reported in growth hormone deficient children treated with somatropin and included in the post-marketing experience. However, there is no evidence of an increased risk of leukaemia without predisposition factors, such as radiation to the brain or head.
Slipped capital femoral epiphysis and Legg-Calvé-Perthes disease Slipped capital femoral epiphysis and Legg-Calvé-Perthes disease have been reported in children treated with GH. Slipped capital femoral epiphysis occurs more frequently in case of endocrine disorders and Legg-Calvé-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. Other adverse drug reactions Other adverse drug reactions may be considered somatropin class effects, such as possible hyperglycaemia caused by decreased insulin sensitivity, decreased free thyroxin level and benign intra-cranial hypertension.
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.
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. Patients limping during treatment with somatropin should be examined clinically.
6 Benign intracranial hypertension In case 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 give specific advice on the continuation of growth hormone treatment in patients with resolved intracranial hypertension. If growth hormone treatment is restarted, careful monitoring for symptoms of intracranial hypertension is necessary.
Leukaemia Leukaemia has been reported in a small number of growth hormone deficiency patients, some of whom have been treated with somatropin. However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposition factors.
Antibodies A small percentage of patients may develop antibodies to Omnitrope. Omnitrope has given rise to the formation of antibodies in approximately 1% of patients. 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. Pancreatitis Although rare, pancreatitis should be considered in somatropin-treated patients who develop abdominal pain, especially in children.
Scoliosis Scoliosis is known to be more frequent in some of the patient groups treated with somatropin. In addition, rapid growth in any child can cause progression of scoliosis. Somatropin has not been shown to increase the incidence or severity of scoliosis.
Signs of scoliosis should be monitored during treatment. Acute critical illness The effects of somatropin on recovery were studied in two placebo controlled trials involving 522 critically ill adult patients suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma or acute respiratory failure.
3 or 8 mg somatropin daily compared to patients receiving placebo, 42% vs. 19%. Based on this information, these types of patients should not be treated with somatropin. As there is no information available on the safety of growth hormone substitution therapy in acutely critically ill patients, the benefits of continued 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 somatropin must be weighed against the potential risk involved. Elderly patients Experience in patients above 80 years is limited.
Elderly patients may be more sensitive to the action of Omnitrope, and therefore may be more prone to develop adverse reactions. Prader-Willi syndrome In patients with PWS, treatment should always be in combination with a calorie-restricted diet.
7 There have been reports of fatalities associated with the use of growth hormone in paediatric patients with PWS who had one or more of the following risk factors: […]