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SAIZEN 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: Saizen is indicated in the treatment of: Children and adolescents: − Growth failure in children caused by decreased or absent secretion of endogenous growth hormone. − Growth failure in girls with gonadal dysgenesis (Turner syndrome), confirmed by chromosomal analysis. − Growth failure in prepubertal children due to…
Verbatim from this product's MHRA label. Tap a section to expand.
easy is intended for multiple dose use. Saizen dosage should be individualised for each patient based on body surface area or on body weight. 035 mg/kg body weight per day by subcutaneous administration. 050 mg/kg body weight per day by subcutaneous administration.
Concomitant therapy with non-androgenic anabolic steroids in patients with Turner syndrome can enhance the growth response. 050 mg/kg body weight per day by subcutaneous administration. 1 IU kg/day or 3 IU m2/day) per day, by subcutaneous administration.
Treatment should be discontinued when the patient has reached a satisfactory adult height, or the epiphyses are fused. For growth disturbance in short children born SGA, treatment is usually recommended until final height is reached.
Treatment should be discontinued after the first year if height velocity SDS is below +1. Treatment should be discontinued when final height is reached (defined as height velocity <2 cm/year), and if confirmation is required if bone age is >14 years (girls) or >16 years (boys), corresponding to closure of the epiphyseal growth plates.
3 mg are recommended, given as a daily subcutaneous injection. The dose should be adjusted stepwise, controlled by Insulin-like Growth Factor 1 (IGF-1) values. 0 mg/day. In general the lowest efficacious dose should be administered. In older or overweight patients, lower doses may be necessary.
2 but no recommendation on a posology can be made. click needle-free auto-injectors or easypod auto-injector. Intended users of easypod are primarily children starting from the age of 7 up to adults. Use of the devices by children should always be made under adult’s supervision.
easy reconstitution device. 6.
Up to 10% of patients may experience redness and itching at the site of injection, particularly when the subcutaneous route is used. Fluid retention is expected during growth hormone replacement therapy in adults. Oedema, joint swelling, arthralgias, myalgias and paraesthesias may be clinical manifestations of fluid retention.
However, these symptoms / signs are usually transient and dose dependent. Adult patients with growth hormone deficiency, following diagnosis of growth hormone deficiency in childhood, reported side-effects less frequently than those with adult onset growth hormone deficiency.
Antibodies to somatropin can form in a small percentage of patients; to date the antibodies have been of low binding capacity and have not been associated with growth attenuation except in patients with gene deletions. In very rare instances, where short stature is due to deletion of the growth hormone gene complex, treatment with growth hormone may induce growth attenuating antibodies.
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 predisposing factors.
The following definitions apply to the frequency terminology used hereafter: 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), frequency not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. System Organ Class Common Uncommon Very rare Frequency not known Nervous system disorders Headache (isolated), carpal tunnel syndrome (in adults) Idiopathic intracranial hypertension (benign intracranial hypertension), carpal tunnel syndrome (in children) Musculoskeletal and connective tissue disorders Slipped capital femoral epiphysis (Epiphysiolysis capitis femoris), or avascular necrosis of the femoral head Immune system disorders Localised and generalised hypersensitivity reactions Endocrine disorders Hypothyroidism Metabolism and nutrition disorders In adults: Fluid retention: peripheral oedema, stiffness, arthralgia, myalgia, paraesthesia In children: Fluid retention: peripheral oedema, stiffness, arthralgia, myalgia, paraesthesia Insulin resistance can result in hyperinsulinism and in rare cases in hyperglycaemia Reproductive system and breast disorders Gynaecomastia General disorders and administration site conditions Injection site reactions, localised lipoatrophy, which can be avoided by varying the site of injection Gastrointestinal disorders Pancreatitis Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Treatment should be carried out under the regular guidance of a physician who is experienced in the diagnosis and management of patients with growth hormone deficiency. 2). Neoplasm Patients with an intra- or extracranial neoplasia in remission who are receiving treatment with growth hormone should be examined carefully and at regular intervals by the physician.
Patients with growth hormone deficiency secondary to an intracranial tumour should be examined frequently for progression or recurrence of the underlying disease process. 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. Prader-Willi syndrome Saizen is not indicated for the long-term treatment of paediatric patients who have growth failure due to genetically confirmed 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 therapy with growth hormone in paediatric 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.
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 predisposing factors.
Insulin sensitivity 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 containing product therapy is instituted.
1. Somatropin should not be used for growth promotion in children with closed epiphyses. 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 therapy.
Treatment should be discontinued if there is evidence of tumour growth. Somatropin must not be used in case of proliferative or preproliferative diabetic retinopathy. Patients with acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions should not be treated with somatropin.
In children with chronic renal disease, treatment with somatropin should be discontinued at renal transplantation.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
Patients with diabetes or glucose intolerance should be monitored closely during somatropin therapy. Retinopathy Stable background retinopathy should not lead to discontinuation of somatropin replacement therapy. Thyroid function Growth hormone increases the extra thyroid 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. Benign intracranial hypertension In case of severe or recurrent headache, visual problems, nausea and/or vomiting, funduscopy for papilloedema is recommended.
If papilloedema is confirmed a diagnosis of benign intracranial hypertension (or pseudotumor cerebri) should be considered and if appropriate, Saizen 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. Pancreatitis Although rare, pancreatitis should be considered in somatropin-treated patients, especially children who develop abdominal pain.
Antibodies As with all somatropin containing products, a small percentage of patients may develop antibodies to somatropin. 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 who fails to respond to therapy.
Slipped capital femoral epiphysis Slipped capital femoral epiphysis is often associated with endocrine disorders such as growth hormone deficiency and hypothyroidism, and with growth spurts. In children treated with growth hormone, slipped capital femoral epiphysis may either be due to underlying endocrine disorders or to the increased growth velocity caused by the treatment.
Growth spurts may increase the risk of joint-related problems, the hip joint being under particular strain during the prepubertal growth spurt. Physicians and parents should be alert to the development of a limp or complaints of hip or knee pain in children treated with Saizen.
Growth failure due to chronic renal failure Patients with growth failure due to chronic renal failure should be examined periodically for evidence of progression of renal osteodystrophy. Slipped capital femoral epiphysis or avascular necrosis of the femoral head may be seen in children with advanced renal osteodystrophy and it is uncertain whether these problems are affected by growth hormone therapy.
X-rays of the hip should be obtained prior to initiating therapy. In children with chronic renal failure, renal function should have decreased to below 50% of normal before therapy is instituted. To verify the growth disturbance, growth should have been followed for a year before institution of therapy.
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 should be discontinued at the time of renal transplantation. Children born 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.
For SGA patients it is recommended to measure fasting insulin and blood glucose before start of treatment and annually thereafter. g. familial history of diabetes, obesity, increased body mass index, severe insulin resistance, acanthosis nigricans) oral glucose tolerance testing (OGTT) should be performed.
If overt diabetes occurs, growth hormone should not be administered. For SGA patients it is recommended to measure IGF-I level before start of […]