This site is intended only for healthcare professionals resident in the United Kingdom

Information relating to specific disease areas aligned to Pfizer’s portfolio and other resources designed for Pfizer medicines.

See all Therapy areas

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.

Explore more

NICE technology appraisal guidance

Find out more about NICE’s technology appraisals on the use of somatropin

Find out more

Endocrine helpline 

Our dedicated nurse team are on hand to support patients being treated with Genotropin and healthcare professionals who have Genotropin patients

Contact the team

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

The Genotropin Delivery portfolio

Learn more about the 3 devices available for Genotropin patients

Learn more

Homecare

Pfizer offers a range of homecare and patient support services to Genotropin patients

Learn more

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

For UK Healthcare Professionals*

These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.

I confirm that I am a healthcare professional* resident in the United Kingdom.

If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.

*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.

PP-PFE-GBR-2688. December 2020

Yes

No