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Efficacy & SafetyAdultAdult Growth Hormone DeficiencyChildrenSmall for Gestational AgeTurner SyndromePrader-Willi SyndromeChronic Renal Insufficiency
Pediatric Growth Hormone Deficiency
Idiopathic Short Stature
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Children

Genotropin® is a GH therapy indicated for GHD1

  

The dosage and administration schedule should be individualised. The injection should be given subcutaneously and the site varied to prevent lipoatrophy.

  

Growth disturbance due to insufficient secretion of GH in children

  

Generally, a dose of 0.025 to 0.035 mg/kg body weight per day (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 and bone mass). For monitoring, the attainment of a normal peak bone mass defined as a T score >−1 (i.e. standardised 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.

  

PWS for the improvement of growth and body composition in children

   

Generally, a dose of 0.035 mg/kg body weight per day (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 TS

   

A dose of 0.045 to 0.050 mg/kg body weight per day (1.4 mg/m² body surface area per day) is recommended.

   

Growth disturbance in chronic renal insufficiency

   

A dose of 0.045 to 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 6 months of treatment.

   

Growth disturbance in short children born SGA

   

A dose of 0.035 mg/kg body weight per day (1 mg/m² body surface area per day) is usually recommended until the final height is reached (see Section 5.1). Treatment should be discontinued after the first year of treatment if the height velocity SDS is below +1. Treatment should be discontinued if the height velocity is <2 cm/year and, if confirmation is required, bone age is >14 years (girls) or >16 years (boys), corresponding to the closure of the epiphyseal growth plates.

   

Dosage Recommendations in Pediatric Patients

   

   

Adapted from Local product document, Somatropin 5.3 mg and 12 mg formulation, Genotropin : Version LPDGEN072022.

   

   

GH, growth hormone; GHD, growth hormone deficiency; PWS, Prader-Willi syndrome; SDS, standard deviation score; SGA, small for gestational age; TS, Turner syndrome.

   

Reference:

Local product document, Somatropin 5.3 mg and 12 mg formulation, Genotropin : Version LPDGEN072022.
Indication
mg/kg body weight
dose per day
mg/m2 body surface area dose per day
Growth hormone deficiency
in children
0.025 - 0.035 0.7 - 1.0
Prader-Willi syndrome in
children
0.035 1.0
Turner syndrome 0.045 - 0.050 1.4
Chronic renal insuffciency 0.045 - 0.050 1.4
Children born small for
gestational age
0.035 1.0

   

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