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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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Small for Gestational Age 

  • Genotropin® is indicated for the treatment of growth disturbance in short children born SGA with a birth weight and/or length below −2 SD.1,2
     
  • Children classified as born SGA may have concurrent diagnoses such as familial short stature, TS or GHD. Approximately 10% of children born SGA do not reach the normal height range.1

Study results: Effects of GH treatment on SGA children treated until reaching their final height

  • Achieving catch-up growth and normalising final height3
     
  • Increase in height following initiation of treatment with GH (0.033 mg/kg/day)3

   

Adapted from Dahlgren J, et al. 2005.3

   

Study methods3

   

Observational study of 77 prepubertal short children born SGA (−2 SD birth weight or length; mean age 10.7 years) in which patients received 0.033 mg/kg/day GH treatment until final height is reached (1 year after height velocity <1 cm/year). During puberty, 28 children were randomised to receive 66 μg/kg/day GH. Children were subdivided according to the duration of GH treatment before puberty (>2 years [n=36] and <2 years [n=41]). Growth response was compared with a comparison group of 34 untreated short prepubertal SGA children. The values are the means ± SE. Mid-parental height SD score.

   

Study findings

   

GH normalised final height in short children born SGA, allowing most patients (86%) to reach their target final height.3

   

Adverse events in the long-term treatment of children with growth disturbance due to born SGA (Clinical trials)2

   

    

Adapted from Genotropin. Local product document. 2022. LPDSOM052020.

    

*Reported in GH-deficient children treated with somatropin, but the incidence appears to be similar to that in children without GHD.
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 the patients and possibly inversely related to the age of the patients at the onset of GHD.
Transient injection site reactions in children have been reported.
§Clinical significance is unknown.

 

ADR, adverse drug reaction; BMD, bone mineral density; GH, growth hormone; GHD, growth hormone deficiency; HDL, high-density lipoprotein; LDL, low-density lipoprotein; QoL, quality of life; SD, standard deviation; SE, standard error; SGA, small for gestational age; TS, Turner syndrome.

  

References:

Human growth hormone (somatropin) for the treatment of growth failure in children. National Institute of Health and Care Excellence. Accessed May 16, 2022. https://www.nice.org.uk/guidance/ta188/resources/human-growth-hormone-somatropin-for-the-treatment-of-growth-failure-inchildren-pdf-82598502860485Genotropin. Local product document. Pfizer; 2022. Version LPDSOM052020.Dahlgren J, Wikland KA; Swedish Study Group for Growth Hormone Treatment. Final height in short children born small for gestational age treated with growth hormone. Pediatr Res. 2005;57(2):216-222.

  

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