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  • Genotropin
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    Active Ingredient
    Somatotrophin 5.3 mg, 12 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Cartridge (solution for injection)

    U2-pen: 5.3 mg

    partial basket chart 19926 7428

    Cartridge (solution for injection)

    U2-pen: 12 mg

    partial basket chart 18549 7429

    Pre-filled Pen

    Go Quick: 5.3 mg

    partial basket chart 30741

    Pre-filled Pen

    Go Quick: 12 mg

    partial basket chart 30739

    Related information


    Dosage

    The dosage and administration schedule should be individualized. The injection should be given subcutaneously and the site varied to prevent lipoatrophy.
    – Growth disturbance due to insufficient secretion of Growth hormone in children: Generally a dose of 0.025-0.035 mg/kg body weight per day or 0.7-1.0 mg/m² body surface area per day is recommended.
    – Prader Willi Syndrome, for improvement of growth and body composition in children: Generally a dose of 0.035 mg/kg body weight per day or 1.0 mg/m² body surface area per day is recommended. Daily doses of 2.7mg should not be exceeded. Treatment should not be used in children with growth velocity less than 1cm per year and near closure of epiphyses.
    – Growth disturbance due to Turner syndrome: A dose of 0.045-0.050 mg/kg body weight per day or 1.4 mg/m² body surface area per day is recommended. Growth disturbance in chronic renal insufficiency: A dose of 1.4 mg/m² body surface area per day (0.045-0.050 mg/kg body weight per day) is recommended. Higher doses may be needed if growth velocity is too low. A dose correction may be needed after six months of treatment. Factor (IGF-I)) in serum should be used as guidance for dose titration. The minimum effective dose should be used and dose requirements may decline with increasing age.
    – In growth disturbances in short children born SGA is usually a dose of 0.035mg/kg body weight per day (1mg/m² body surface area per day) is recommended, until final height is reached (see Pharmacodynamic properties section). Treatment should be discontinued after 1 year if the height velocity SDS is below +1. The treatment should be discontinued if height velocity is < 2 cm/year and, if confirmation is required, bone age > 14 years (girls) or > 16 years (boys), corresponding to the closure of the epiphyseal growth plates.
    Dosage Recommendations: The dosage and administration schedule should be individualized. Somatropin should be given subcutaneously and the injection site varied to prevent lipoatrophy. See prescribing information for full details.
    Growth hormone deficient adult patients: Therapy should start with a low dose, 0.15-0.3mg (0.45 to 0.90 IU) per day. The final dose should be gradually increased according to individual patient requirements as determined by the IGF-I concentration with respect to age and gender. Treatment goal should be insulin-like growth factor (IGF-1) 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 upper range of normal, not exceeding the 2 SDS. Clinical response and side effects may be used as guidance for dose titration. The daily maintenance dose seldom exceeds 1.3 mg (4 IU) per day. 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 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 decreased with age, dose requirements may be reduced. Clinical response, side effects, and determination of IGF-I in serum may be used as guidance for dose titration. The minimum effective dose should be used.
    See prescribing information for full details.


    Indications

    Children: Short stature due to inadequate or failed secretion of pituitary growth hormone or Turner’s syndrome. Short stature in children with chronic renal insufficiency. Growth disturbance (height SDS< -2.5 and parental adjusted height SDS< -1) in short children born SGA (SGA – small for gestational age, i.e. born small in relation to the length of the fetus development), with a birth weight and/or length < -2 SD, who failed to show catch up growth (HV SDS <0 during the last year) by 4 years of age or later. In Prader-Willi syndrome (PWS) to improve growth and body composition. The diagnosis of PWS should be confirmed by genetic analysis.
    Adults: For adults who have suffered from growth-hormone deficiency since childhood. For adults who have acquired growth hormone deficiency due to a pituitary pathology causing hypopituitarism.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.
    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.
    Genotropin should not be used for growth promotion in children with closed epiphyses.
    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 Genotropin (regarding patients undergoing substitution therapy.
    Somatropin is contraindicated in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment (see Warnings and precautions).
    Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.


    Special Precautions

    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 in the majority of 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.
    Benign intracranial hypertension: 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. 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: 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. 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.
    See prescribing information for full details.


    Side Effects

    Patients with growth hormone deficiency are characterized by extracellular volume deficit. When treatment with somatropin is started this deficit is rapidly corrected. In adult patients adverse effects related to fluid retention, such as oedema peripheral, musculoskeletal stiffness, arthralgia, myalgia and paraesthesia are common. In general these adverse effects are mild to moderate, arise within the first months of treatment and subside spontaneously or with dose-reduction.
    The incidence of these adverse effects 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. In children such adverse effects are uncommon.
    Genotropin has given rise to the formation of antibodies in approximately 1 % of the patients. The binding capacity of these antibodies has been low and no clinical changes have been associated with their formation.
    See prescribing information for full details.


    Drug interactions

    Concomitant treatment with glucocorticoids may inhibit the growth-promoting effects of somatropin containing products. Therefore, patients treated with glucocorticoids should have their growth monitored carefully to assess the potential impact of glucocorticoid treatment on growth. Data from an interaction study performed in growth hormone deficient adults, suggests that somatropin administration may increase the clearance of compounds known to be metabolised by cytochrome P450 isoenzymes. The clearance of compounds metabolised by cytochrome P 450 3A4 (e.g. sex steroids, corticosteroids, anticonvulsants and ciclosporin) may be especially increased resulting in lower plasma levels of these compounds. The clinical significance of this is unknown.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: Somatropin containing products are not recommended during pregnancy and in women of childbearing potential not using contraception.
    Lactation: There have been no clinical studies conducted with somatropin containing products in breast-feeding women. Caution should be exercised when somatropin containing products are administered to breast-feeding women.
    See prescribing information for full details.


    Overdose

    Symptoms: Acute overdosage could lead initially to hypoglycaemia and subsequently to hyperglycaemia. Long-term overdosage could result in signs and symptoms consistent with the known effects of human growth hormone excess.


    Important notes

    Storage: From a microbiological point of view, once reconstituted, the product may be stored for 4 weeks at 2°C – 8°C. Other in-use storage times and conditions are the responsibility of the user. 


    Manufacturer
    PFIZER Manufacturing Belgium NV, Belgium
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