Paediatric Growth Hormone Deficiency

Genotropin^® has proven efficacy in PGHD¹ for achievement of genetic height potential²

Genotropin^® is effective in treating idiopathic PGHD²

Adapted from Cutfield W, et al. 1999.²

Study methods²

An analysis of the final height in idiopathic GHD patients enrolled in the KIGS database was performed. Of the 10,657 idiopathic GHD patients enrolled from 43 participating countries, 369 fulfilled the necessary final height criteria for inclusion in the analysis and were treated on an average dose of 0.49 IU/kg body weight/week (0.16 mg/kg body weight/week) GH for a median of 8.1 years. A Swedish subgroup of patients (n=69) received conventional therapy (0.65 IU/kg body weight/week) for a mean of 9.4 years. The criteria used to define the final height were height velocity less than 2 cm/year, calculated over a minimum period of 9 months; chronological age greater than 17 years or bone age greater than 16 years in boys; chronological age greater than 15 years or bone age greater than 14 years in girls. To be included in the analysis, the children had to have more than 2 years of GH treatment prior to puberty and more than 5 years of GH treatment in total.

Safety³

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; KIGS, Kabi International Growth Study; PWS, Prader-Willi syndrome; PGHD, paediatric growth hormone deficiency; SD, standard deviation; SDS, standard deviation score.

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