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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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Turner Syndrome

Normalisation of height with induction of puberty at an appropriate time1,2

   

A significant improvement is observed in the height SDS relative to TS-specific height references (P<0.05) in girls with TS treated to NAH.

   

Normalisation of Height with Induction of Puberty at an Appropriate time1,2

   

Adapted from Ranke MB, et al. 2007.2

   

Study methods2

   

Height SDS data reported at the start of GH therapy (mean age 8.6 years), during the first year of treatment and during puberty of 1146 girls with TS from published data, treated to NAH (mean dose of 0.29 mg/kg body weight/week).

Safety3

   

Adverse events in the long-term treatment of children with growth disturbance due to TS

   

   

Adapted from Local product document, Somatropin 5.3 mg and 12 mg formulation, Genotropin : Version LPDGEN072022 2022. 

   

   

*Reported in growth hormone deficient children treated with somatropin, but the incidence appears to be similar to that in children without growth hormone deficiency.
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 growth hormone deficiency.
Transient injection site reactions in children have been reported.
§Clinical significance is unknown.

   

ADR, adverse drug reaction; GH, growth hormone; GHD, growth hormone deficiency; NAH, near adult height; SDS, standard deviation score; TS, Turner syndrome.

   

References:

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.Ranke MB, Lindbeg A. Turner syndrome within KIGS including an analysis of 1146 patients grown to near adult height. Karger. 2007;332-339.Local product document, Somatropin 5.3 mg and 12 mg formulation, Genotropin : Version LPDGEN072022.

   

PP-GEN-IND-0942 June 2023

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