Loading…
NORDITROPIN FLEXPRO 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: Children: Growth failure due to growth hormone deficiency (GHD) Growth failure in girls due to gonadal dysgenesis (Turner syndrome) Growth retardation in prepubertal children due to chronic renal disease Growth disturbance (current height SDS < -2.5 and parental adjusted height SDS < - 1) in short children born small…
Verbatim from this product's MHRA label. Tap a section to expand.
Norditropin should only be prescribed by doctors with special knowledge of the therapeutic indication of use. Posology The dosage is individual and must always be adjusted in accordance with the individual's clinical and biochemical response to therapy.
0 mg/m2/day When GHD persists after growth completion, growth hormone treatment should be continued to achieve full somatic adult development including lean body mass and bone mineral accrual (for guidance on dosing, see Replacement therapy in adults).
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.
1). 4).
Adult population:
Replacement therapy in adults The dosage must be adjusted to the need of the individual patient. 5 mg/day with subsequent dose adjustment on the basis of IGF-1 concentration determination. 3 mg/day. It is recommended to increase the dosage gradually at monthly intervals based on the clinical response and the patient’s experience of adverse events.
Serum IGF-1 can be used as guidance for the dose titration. Women may require higher doses than men, with men showing an increasing IGF-1 sensitivity over time. This means that there is a risk that women, especially those on oral oestrogen replacement are undertreated while men are overtreated.
Dose requirements decline with age. 0 mg/day. Method of administration Generally, daily subcutaneous administration in the evening is recommended. The injection site should be varied to prevent lipoatrophy.
Growth hormone deficient patients are characterised by extracellular volume deficit. When treatment with somatropin is initiated, this deficit is corrected. Fluid retention with peripheral oedema may occur especially in adults. Carpal tunnel syndrome is uncommon, but may be seen in adults.
The symptoms are usually transient, dose dependent and may require transient dose reduction. Mild arthralgia, muscle pain and paresthesia may also occur but are usually self-limiting. Adverse reactions in children are uncommon or rare.
Clinical trial experience:
System organ classes 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) Metabolism and nutrition disorders In adults Diabetes mellitus type 2 Nervous system disorders In adults headache and paraesthesia In adults carpal tunnel syndrome.
In children headache Skin and subcutaneous tissue disorders In adults pruritus In children rash Musculoskeletal, connective tissue disorders In adults arthralgia, joint stiffness and myalgia In adults muscle stiffness In children arthralgia and myalgia Reproductive system and breast disorders In adults and children Gynecomastia General disorders and administration site In adults peripheral oedema (see In adults and children injection site pain.
In children In children peripheral oedema conditions text above) injection site reaction In children with Turner syndrome increased growth of hands and feet has been reported during somatropin therapy. A tendency for increased incidence of otitis media in Turner syndrome patients treated with high doses of Norditropin has been observed in one open-label randomised clinical trial.
However, the increase in ear infections did not result in more ear operations/tube insertions compared to the lower dose group in the trial.
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 Children treated with somatropin should be regularly assessed by a specialist in child growth.
Somatropin treatment should always be instigated by a physician with special knowledge of growth hormone insufficiency and its treatment. This is true also for the management of Turner syndrome, chronic renal disease, SGA and Noonan syndrome.
Data of final adult height following the use of Norditropin are limited for children with Noonan Syndrome and are not available for children with chronic renal disease. 2). The stimulation of longitudinal growth in children can only be expected until epiphyseal closure.
Children Treatment of growth hormone deficiency in patients with Prader-Willi syndrome There have been reports of sudden death after initiating somatropin 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.
Small for Gestational Age In short children born SGA other medical reasons or treatments that could explain growth disturbance should be ruled out before starting treatment. Experience in initiating treatment in SGA patients near onset of puberty is limited.
It is therefore not recommended to initiate treatment near onset of puberty. Experience with patients with Silver-Russell syndrome is limited. Turner syndrome Monitoring of growth of hands and feet in Turner syndrome patients treated with somatropin is recommended, and a dose reduction to the lower part of the dose range should be considered if increased growth is observed.
Girls with Turner syndrome generally have an increased risk of otitis media, which is why otological evaluation is recommended on at least an annual basis. 2). The growth disturbance should be clearly established before somatropin treatment by following growth on optimal treatment for renal disease over one year.
1. 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 growth hormone (GH) therapy. Treatment should be discontinued if there is evidence of tumour growth.
Somatropin should not be used for longitudinal growth promotion in children with closed epiphyses. 4). In children with chronic renal disease, treatment with Norditropin FlexPro should be discontinued at renal transplantation.
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.
Post-marketing experience:
In addition to the above mentioned adverse drug reactions, those presented below have been spontaneously reported and are by an overall judgement considered possibly related to Norditropin treatment. 3). Formation of antibodies directed against somatropin.
The titres and binding capacities of these antibodies have been very low and have not interfered with the growth response to Norditropin administration - Endocrine disorders: Hypothyroidism. 4) - Musculoskeletal and connective tissue disorders: Legg-Calvé-Perthes disease.
Legg- Calvé-Perthes disease may occur more frequently in patients with short stature - Investigations: Increase in blood alkaline phosphatase level. 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.
Conservative management of uraemia with customary medicinal product and if needed dialysis should be maintained during somatropin therapy. Patients with chronic renal disease normally experience a decline in renal function as part of the natural course of their illness.
However, as a precautionary measure during somatropin treatment, renal function should be monitored for an excessive decline or increase in the glomerular filtration rate (which could imply hyperfiltration). Scoliosis Scoliosis is known to be more frequent in some of the patient groups treated with somatropin for example Turner syndrome and Noonan syndrome.
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. Blood glucose and insulin In Turner syndrome and SGA children it is recommended to measure fasting insulin and blood glucose before start of treatment and annually thereafter.
g. familial history of diabetes, obesity, severe insulin resistance, acanthosis nigricans), oral glucose tolerance testing (OGTT) should be performed. If overt diabetes occurs, somatropin should not be administered. Somatropin has been found to influence carbohydrate metabolism, therefore, patients should be observed for evidence of glucose intolerance.
IGF-1 In Turner syndrome and SGA children it is recommended to measure the IGF-1 level before start of treatment and twice a year thereafter. If on repeated measurements IGF-1 levels exceed +2 SD compared to references for age and pubertal status, the dose should be reduced to achieve an IGF-1 level within the normal range.
Some of the height gain obtained with treating short children born SGA with somatropin may be lost if treatment is stopped before final height is reached. Adults Growth hormone deficiency in adults Growth hormone deficiency in adults is a lifelong disease and needs to be treated accordingly, however, experience in patients older than 60 years and in patients with more than five years of treatment in adult growth hormone deficiency is still limited.
Adults and Children Pancreatitis Although rare, pancreatitis should be considered in somatropin-treated patients who develop abdominal pain, especially in children. General Neoplasms There is no evidence for increased risk of new primary cancers in children or in adults treated with somatropin.
In patients in complete remission from tumours or malignant disease, somatropin therapy has not been associated with an increased relapse rate. An overall slight increase in second neoplasms has been observed in childhood cancer survivors treated with growth hormone, with the most frequent being intracranial tumours.
The dominant risk factor for second neoplasms seems to be prior exposure to radiation. Patients who have achieved complete remission of malignant disease should be followed closely for relapse after commencement of somatropin therapy.
Leukaemia Leukaemia has been reported in a small number of growth hormone deficient patients, some of whom have been treated with somatropin. However, there is no evidence that leukaemia incidence is increased in somatropin recipients without predisposition factors.
Benign intracranial hypertension In the event 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 somatropin treatment should be discontinued.
At […]