Home | Genotropin® (somatropin)

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Adverse event reporting can be found at the bottom of the page

AdultAdult Indication

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Prescribing Information for Genotropin® (somatropin) can be found here. Adverse event reporting can be found at the bottom of the page.

Welcome to Genotropin!

Use this page to find key information to support your prescribing of Genotropin.

To order starter kits and other consumables, click here

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Indications¹

Paediatric

Adult

Growth disturbance due to insufficient secretion of growth hormone (growth hormone deficiency, GHD) and growth disturbance associated with Turner syndrome or chronic renal insufficiency.

Growth disturbance [current height standard deviation score (SDS) < - 2.5 and parental adjusted height SDS < - 1] 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 [height velocity (HV) SDS <0 during the last year] by 4 years of age or later.

Prader-Willi syndrome (PWS), for improvement of growth and body composition. The diagnosis of PWS should be confirmed by appropriate genetic testing.

Replacement therapy in adults with pronounced growth hormone deficiency.

Adult Onset: Patients who have severe growth hormone deficiency associated with multiple hormone deficiencies as a result of known hypothalamic or pituitary pathology, and who have at least one known deficiency of a pituitary hormone not being prolactin. These patients should undergo an appropriate dynamic test in order to diagnose or exclude a growth hormone deficiency.

Childhood Onset: Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes. Patients with childhood onset GHD should be re-evaluated for growth hormone secretory capacity after completion of longitudinal growth. In patients with a high likelihood for persistent GHD, i.e. a congenital cause or GHD secondary to a pituitary/hypothalamic disease or insult, an insulin-like growth factor-1 (IGF-1) SDS < - 2 off growth hormone treatment for at least 4 weeks should be considered sufficient evidence of profound GHD.

All other patients will require IGF-1 assay and one growth hormone stimulation test.

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Safety¹

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Tabulated list of adverse reactions. For full details regarding adverse events and selected adverse reactions please refer to the Summary of Product Characteristics
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)			(Children) Leukaemia^†
Metabolism and Nutrition Disorders						(Adults and Children) Type 2 diabetes mellitus
Nervous System Disorders		(Adults) Paraesthesia* (Adults) Carpal tunnel syndrome	(Children) Benign intracranial hypertension (Children) Paraesthesia*			(Adults) Benign intracranial hypertension (Adults and Children) Headache
Skin and Subcutaneous Tissue Disorders			(Children) Rash, Pruritus, Urticaria**			(Adults) Rash, Pruritus, Urticaria**
Musculoskeletal, Connective Tissue and Bone Disorders	(Adults) Arthralgia*	(Adults) Myalgia* (Adults) Musculoskeletal stiffness* (Children) Arthralgia*	(Children) Myalgia*			(Children) Musculoskeletal stiffness*
Reproductive System and Breast Disorders			(Adults and Children) Gynaecomastia
General Disorders and Administration Site Conditions	(Adults) Oedema peripheral *	(Children) Injection-site reaction^$	(Children) Oedema peripheral*			(Adults and Children) Face oedema* (Adults) Injection-site reaction^$
Investigations						(Adults and Children) 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.

Dosing¹

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The dosage and administration schedule should be individualised. The injection should be given subcutaneously and the site varied to prevent lipoatrophy.

Paediatric

Dosage recommendations in Paediatric Patients
Indication	mg/kg body weight dose per day	mg/m² body surface area dose per day
Growth hormone deficiency in children	0.025 - 0.035	0.7 - 1.0
Prader-Willi syndrome in children	0.035	1.0
Turner syndrome	0.045 - 0.050	1.4
Chronic renal insufficiency	0.045 - 0.050	1.4
Children born small for gestational age	0.035	1.0

Adult

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Dosage recommendations in Adult Patients
Genotropin Starting Dose	Dose Titration*	Treatment Goal
Adults with GHD continuing GH therapy after childhood GHD Recommended dose 0.2 - 0.5mg/ day	Gradually increase or decrease dose According to individual patient requirements	IGF-1 concentration within 2 SDS from the age corrected mean†
Adult-onset GHD Recommended dose 0.15 - 0.3mg/day	Gradually increase dose According to individual patient requirements	IGF-1 concentration within 2 SDS from the age corrected mean†
Adults aged > 60 years Recommended dose 0.1 - 0.2mg/day	Gradually increase dose According to individual patient requirements	The minimum effective dose should be used

For full details regarding dosing please refer to the Summary of Product Characteristics.

Women may require higher doses than men, with men showing an increasing IGF-1 sensitivity over time. This means that there is a risk that women, especially those on oral oestrogen replacement are under-treated while men are over-treated. The accuracy of the growth hormone dose should therefore be controlled every 6 months.

* Clinical response and side effects may also be used as guidance for dose titration. Some patients with GHD do not normalise IGF-1 levels despite a good clinical response, and therefore do not require dose escalation.
† For patients with normal IGF-1 concentrations at the start of the treatment, GH should be administered up to an IGF-1 level into upper range of normal, not exceeding 2 SDS from the age-corrected mean.

Starting Genotropin

Homecare:
We offer an at home medication delivery service and face to face nursing support through a range of providers.

Free and flexible home delivery of Genotropin
Standard Homecare service: up to 2 face-to-face or virtual home nurse visits

For information on your homecare provider and how to register patients, speak to your homecare pharmacy team.

Starter Kits:
Each Genotropin starter kit contains*:

Appropriate Genotropin training device
Injection pad (for practising techniques)
Box of swabs
Sharps bin

*subject to availability

Please note that Pfizer is no longer able to provide cool bags for patients travelling with their medication.

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Device Information

Gentropin Pen^2,3

Two dosage formats: Genotropin® pen cartridges are available in two dosage presentations: 5.3mg and 12mg strengths.
Patients requiring a dose of under 0.5mg/day should be prescribed the 5.3mg pen. Patients requiring a higher dose should be prescribed the 12mg pen. This is to help ensure minimum wastage.
Genotropin pen comes with an optional needle guard
Colour Coding: Cartridges are colour coded to facilitate confirmation that the correct strength of somatropin has been dispensed (Blue Pen = 5.3mg, Purple Pen = 12mg)
Genotropin pen comes in a hard, protective case, which can be used for everyday storage or transportation.

Storage¹

Before reconstitution, store in a refrigerator (2°C – 8°C), or for a maximum of 1 month at or below 25°C. Keep the two-chamber cartridge in the outer carton in order to protect from light.
After reconstituion, store in the refrigerator (2°C - 8°C) for up to 28 days. Do not freeze. Keep the two-chamber cartridge in the outer carton in order to protect from light.

Genotropin GoQuick⁴

Blue GoQuick Pen: 5.3mg
Purple GoQuick Pen: 12mg
All GoQuick pens are prepared and used in the same way.
Pre-filled and disposable
Dose is set once and does not have to be re-set for every use, meaning the correct dose can be administered every time.

Storage¹

Before reconstitution, store in a refrigerator (2°C – 8°C), or for a maximum of 1 month at or below 25°C. Keep the pre-filled pen in the outer carton in order to protect from light.
After reconstitution, store in a refrigerator (2°C – 8°C) for up to 28 days. Do not freeze. Keep the two-chamber cartridge in the outer carton in order to protect from light.

Genotropin MiniQuick⁵

Pre-filled and disposable.
Reusable MiniQuick shell can be used with each MiniQuick
Single fixed dose – no dose setting required, reducing the risk of incorrect dosing.
Available in different strengths
6 step process for the patient combined with dosage accuracy for the healthcare professional.
Packaged in a 7-day supply.

Storage¹

Before reconstitution, store in the refrigerator. Before opening, the product can be stored below 25°C for up to 6 months
After reconstitution it can be stored in a refrigerator (2°C - 8°C) for up to 24 hours if not used immediately

References:

1. GENOTROPIN Summary of Product Characteristics: Click here.
2. GENOTROPIN Instructions for Use- 5.3mg Pen
3. GENOTROPIN Instructions for Use- 12mg Pen
4. GENOTROPIN Patient Information Leaflet- GoQuick: Click here.
5. GENOTROPIN Patient Information Leaflet- MiniQuick: Click here.

PP-GEN-GBR-1971. March 2025

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk 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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