pak2. GENOTROPIN – 12 MG 36 UI PEN 2×36 ui – total 72 ui

• Pediatric GHD in children 
• Idiopathic short stature (ISS)* in children
• Prader-Willi syndrome (PWS)^† in children
• Small for gestational age (SGA) in children
• Turner syndrome (TS) in girls
• Adult GHD

Children

Growth disturbance due to insufficient secretion of growth hormone (growth hormone deficiency, GHD) and growth disturbance associated with Turner syndrome or chronic renal insufficiency.

Growth disturbance [current height standard deviation score (SDS) < – 2.5 and parental adjusted height SDS < – 1] in short children born small for gestational age (SGA), with a birth weight and/or length below – 2 SD, who failed to show catch-up growth [height velocity (HV) SDS <0 during the last year] by 4 years of age or later.

Prader-Willi syndrome (PWS), for improvement of growth and body composition. The diagnosis of PWS should be confirmed by appropriate genetic testing.

Adults

Replacement therapy in adults with pronounced growth hormone deficiency.

Adult Onset: Patients who have severe growth hormone deficiency associated with multiple hormone deficiencies as a result of known hypothalamic or pituitary pathology, and who have at least one known deficiency of a pituitary hormone not being prolactin. These patients should undergo an appropriate dynamic test in order to diagnose or exclude a growth hormone deficiency.

Childhood Onset: Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes. Patients with childhood onset GHD should be re-evaluated for growth hormone secretory capacity after completion of longitudinal growth. In patients with a high likelihood for persistent GHD, i.e. a congenital cause or GHD secondary to a pituitary/hypothalamic disease or insult, an insulin-like growth factor-I (IGF-I) SDS < – 2 off growth hormone treatment for at least 4 weeks should be considered sufficient evidence of profound GHD.

All other patients will require IGF-I assay and one growth hormone stimulation test.

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. Even higher doses have been used.

Where childhood onset GHD persists into adolescence, treatment should be continued to achieve full somatic development (e.g. body composition, bone mass). For monitoring, the attainment of a normal peak bone mass defined as a T score > – 1 (i.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.

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 2.7 mg should not be exceeded. Treatment should not be used in children with a growth velocity of less than 1 cm 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 0.045 – 0.050 mg/kg body weight per day (1.4 mg/m² body surface area per day) is recommended. Higher doses can be needed if growth velocity is too low. A dose correction can be needed after six months of treatment.

Growth disturbance in short children born small for gestational age: A dose of 0.035 mg/kg body weight per day (1 mg/m² body surface area per day) is usually recommended until final height is reached. 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.

Growth hormone deficient adult patients: In patients who continue growth hormone therapy after childhood GHD, the recommended dose to restart is 0.2 – 0.5 mg per day. The dose should be gradually increased or decreased according to individual patient requirements as determined by the IGF-I concentration.

In patients with adult-onset GHD, therapy should start with a low dose, 0.15 – 0.3 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 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 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 recognised 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. The maintenance dose seldom exceeds 1.0 mg 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 decreases with age, dose requirements are reduced. In patients above 60 years, therapy should start with a dose of 0.1 – 0.2 mg per day and should be slowly increased according to individual patient requirements. The minimum effective dose should be used. The maintenance dose in these patients seldom exceeds 0.5 mg per day.