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

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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 & Small for Gestational Age (SGA) patients

Genotropin is indicated for the treatment of growth disturbance in short children born small for gestational age (SGA), with a birth weight and/or length below - 2 SD, who failed to show catch-up growth by 4 years of age or later.2
​​​​​​​Children classified as born small for gestational age may have concurrent diagnoses such as familial short stature, Turner syndrome, or growth hormone deficiency. Approximately 10% of children born small for gestational age do not reach the normal height range. Those whose growth has not caught up by 4 years of age are candidates for treatment with growth hormone.3

Study results: effect of growth hormone (GH) on SGA children treated until final height

Achieving catch-up growth and normalising final height 1

Increase in height following initiation of treatment with growth hormone (GH) (0.033mg/kg/day) 1

Effect of growth hormone (GH) on SGA children treated until final height

Δ GH treated >2 year before puberty

▽ GH treated <2 years before puberty

O Untreated group 

Adapted from Dahlgren et al, 2005 1

Study findings

GH normalised final height in short children born SGA, allowing most patients to reach their target final height.1

Study methods

Observational study of 77 pre-pubertal short children born SGA (-2SD birth weight or length; mean age 10.7 years) in which patients received 0.033 mg/kg/day GH treatment until final height (1 year after height velocity <1 cm/year). During puberty, 24 children were randomised to 66 µg/kg/day GH. Children were subdivided according to the duration of GH treatment before puberty (>2 years [n=36] and < 2 years [n=41]). Growth response was compared with a comparison group of 34 untreated short pre-pubertal SGA children. Values are means ± standard error (SE). MPH SDS mid-parental height SD score.

Dosing2

Dosage recommendations in SGA Patients

Indication

mg/kg body weight dose per day

mg/m2 body surface area dose per day

Small for Gestational Age

0.035

1.0

Treatment should be discontinued after the first year of treatment if the height velocity SDS is below + 1. Treatment should be discontinued if height velocity is < 2 cm/year and, if confirmation is required, bone age is > 14 years (girls) or > 16 years (boys), corresponding to closure of the epiphyseal growth plates.

Please refer to the Summary of Product Characteristics for full information before prescribing Genotropin

Safety​​​​​​​2

Adverse events in the long-term treatment of Children with Growth Disturbance due to Born Small for Gestational Age​​​​​​​​​​​​​​

Long-term Treatment of Children with Growth Disturbance due to Born Small for Gestational Age

​​​​​​​System Organ Class

​​​​​​​Very Common ≥ 1/10

Common ≥ 1/100 to <1/10

Uncommon ≥ 1/1,000 to <1/100

Rare ≥ 1/10,000 to <1/1,000

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 Subcutaneous Tissue Disorders

Rash**
Urticaria**

Pruritus**

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 Genotropin for Adult Growth Hormone Deficiency

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

Turner Syndrome

Watch Dr Helen Turner talk about the early diagnosis of Turner syndrome, the commonest chromosomal disorder in women 

Find out more 

MiniQuick dosing and demonstration

Watch how a child patient takes Genotropin with the Miniquick device

Find out 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

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PP-PFE-GBR-2688. December 2020

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