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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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Prader-Willi Syndrome 

Genotropin® has a proven, favourable effect on growth and body composition in PWS1,2

  • Improvement in height and body composition1
     

  • Improvement in height and BMI SDS in children with PWS during 5 years of Genotropin® (0.033 mg/kg/day) treatment1

   

Adapted from Lindgren AC, et al. 1999.1

   

Study methods1

   

A controlled, randomised GH treatment study was conducted in 29 prepubertal children (3-12 years) with PWS. Height and BMI SDS data were reported from a follow-up of 9 Swedish children treated initially for 2 years with 0.033 mg/kg/day GH. GH treatment was stopped for 6 months and thereafter restarted at the same dose for the remainder of the study duration. The values are the means ± SD. 

   

Safety2

   

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

   

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

   

   

*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; BMI, body mass index; GH, growth hormone; GHD, growth hormone deficiency; PWS, Prader-Willi syndrome; SD, standard deviation; SDS, standard deviation score.
 

References:

Lindgren AC, Ritzén EM. Five years of growth hormone treatment in children with Prader-Willi syndrome. Swedish National Growth Hormone Advisory Group. Acta Paediatr Suppl. 1999;88(433):109-111.Local product document, Somatropin 5.3 mg and 12 mg formulation, Genotropin : Version LPDGEN072022.

   

PP-GEN-IND-0942 June 2023

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