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Information on how to access Genotropin® (somatropin, rbe) prescribing information and adverse event reporting can be found at the bottom of the page.

Genotropin efficacy in normalisation of height at puberty in children with chronic renal insufficiency

Genotropin is indicated for the treatment of growth disturbance in children associated with chronic renal insufficiency. 

Chronic renal insufficiency (CRI), which may include end stage renal disease, is defined as a persistent elevation of serum creatinine and/or urea. CRI can be caused by a variety of conditions, including congenital disorders, glomerular disorders and infections1.

Chronic kidney disease (CKD) in children is associated with growth impairment, mainly due to disturbances in growth hormone (GH) metabolism and its main mediator, insulin-like growth factor-I (IGF-I)2.

Growth failure associated with CRI usually begins when the glomerular filtration rate falls to 50% of normal​​​​​​​1. However, significant short stature has been seen at all levels of renal function3,4​​​​​​​,5.

Somatropin efficacy in normalisation of height at puberty in children with chronicrenal insufficiency

Prepubertal height gain and normalisation of height5​​​​​​​.

Change from initially predicted adult height at baseline in children receiving growth hormone (GH; 0.33 mg/kg body weight/week) vs 50 untreated children5

Prepubertal height gain and normalisation of height 5

Change from initially predicted adult height at baseline in children receiving growth hormone (GH; 0.33 mg/kg body weight/week) vs 50 untreated children 5

Adapted from Haffner et al. 2000 5
* Significant differences from the previous period (p < 0.001)
† Significant differences from the children who were not treated with growth hormone (p < 0.001)

Study methods

38 children (32 boys and 6 girls) from a German multicentre study, who had reached final adult height at the time of analysis. The control group consisted of 50 children (31 boys and 19 girls) with chronic renal failure, who were matched with GH treated children. Values are means ± standard deviation (SD).​​​​​​​

Dosing6

Dosage recommendations in CRI Patients

Indication

​​​​​​​mg/kg body weight dose per day

mg/m2 body surface area dose per day

Chronic Renal Insufficiency

0.045-0.050

1.4


Higher doses can be needed if growth velocity is too low; a dose correction may be needed after six months of treatment.

In chronic renal insufficiency, renal function should be below 50% of normal before institution of therapy.To verify growth disturbance, growth should be followed for a year preceding institution of therapy. Treatment should be discontinued at renal transplantation. 
​​​​​​​
Please refer to the Summary of Product Characteristics for full information before prescribing Genotropin

Safety6

Adverse Events in the long-term treatment of Children with Growth Disturbance due to Chronic Renal Insufficiency 

Long-Term Treatment of Children with Growth Disturbance due to Chronic Renal Insufficiency

System Organ Class

​​​​​​​Very Common ≥ 1/10

Common ≥ 1/100 to <1/10

Uncommon ≥ 1/1000 to <1/100

Rare ≥ 1/10,000 to <1/1000

Very Rare <1/10,000

Not Known (cannot be estimated from available data)

Neoplasms Benign, Malignant, and Unspecified (including cysts and polyps)

Leukaemia

Metabolism and Nutrition Disorders

Type 2 diabetes mellitus

Nervous System Disorders

Paraesthesia*
Benign intracranial hypertension

Skin and Subcutaenous Tissue Disorders

Rash**

Pruritus**

Urticaria**

Musculoskeletal, Connective Tissue, and Bone Disorders

Arthralgia*
​​​​​​​
Myalgia*
Musculoskeletal stiffness*

General Disorders and Administration Site Conditions

Injection site reaction$

Oedema peripheral*

Face Oedema*

Investigations

Blood cortisol decreased

*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.
**Adverse Drug Reactions (ADR) identified post-marketing
$ Transient injection site reactions in children have been reported.
‡ Clinical significance is unknown.
† Reported in growth hormone deficient children treated with somatropin, but the incidence appears to be similar to that in children without growth hormone deficiency.

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References
  1. NICE Guidance [TA188]. Human growth hormone (somatropin) for the treatment of growth failure in children, 2010. Accessed here.
    2. Becherucci F, et al. Clinical Kidney Journal 2016, 9: 583-591
    3. Van Dyck M, Bilem N, Proesmans W. Pediatr Nephrol 1999, 13(9): 865-869
    4. Mahan JD, Warady BA. Pediatr Nephrol 2006, 21(7):917-930
    5. Haffner D, et al. N Engl J Med 2000, 343(13): 923–930
    6. Genotropin Summary of Product Characteristics, available here.
PP-GEN-GBR-1068. April 2021

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