Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
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-I (IGF-I) 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-I assay and one growth hormone stimulation test.
The dosage and administration schedule should be individualized.
The injection should be given subcutaneously and the site varied to prevent lipoatrophy.
Generally a dose of 0.025-0.035 mg/kg body weight per day or 0.7-1.0 mg/m² body surface area per day is recommended. Even higher doses have been used.
Where childhood onset GHD persists into adolescence, treatment should be continued to achieve full somatic development (e.g. body composition, bone mass). For monitoring, the attainment of a normal peak bone mass defined as a T score > - 1 (i.e. standardized to average adult peak bone mass measured by dual energy X-ray absorptiometry taking into account sex and ethnicity) is one of the therapeutic objectives during the transition period. For guidance on dosing see adult section below.
Generally a dose of 0.035 mg/kg body weight per day or 1.0 mg/m² body surface area per day is recommended. Daily doses of 2.7 mg should not be exceeded. Treatment should not be used in children with a growth velocity of less than 1 cm per year and near closure of epiphyses.
A dose of 0.045-0.050 mg/kg body weight per day or 1.4 mg/m² body surface area per day is recommended.
A dose of 0.045-0.050 mg/kg body weight per day (1.4 mg/m² body surface area per day) is recommended. Higher doses can be needed if growth velocity is too low. A dose correction can be needed after six months of treatment.
A dose of 0.035 mg/kg body weight per day (1 mg/m² body surface area per day) is usually recommended until final height is reached (see section 5.1). 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.
Dosage recommendations in Pediatric 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 |
In patients who continue growth hormone therapy after childhood GHD, the recommended dose to restart is 0.2–0.5 mg per day. The dose should be gradually increased or decreased according to individual patient requirements as determined by the IGF-I concentration.
In patients with adult-onset GHD, therapy should start with a low dose, 0.15–0.3 mg per day. The dose should be gradually increased according to individual patient requirements as determined by the IGF-I concentration.
In both cases treatment goal should be IGF-I concentrations within 2 SDS from the age corrected mean. Patients with normal IGF-I concentrations at the start of the treatment should be administered growth hormone up to an IGF-I level into upper range of normal, not exceeding the 2 SDS. Clinical response and side effects may also be used as guidance for dose titration. It is recognised that there are patients with GHD who do not normalize IGF-I levels despite a good clinical response, and thus do not require dose escalation. The maintenance dose seldom exceeds 1.0 mg per day.
Women may require higher doses than men, with men showing an increasing IGF-I 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. As normal physiological growth hormone production decreases with age, dose requirements are reduced.
In patients above 60 years, therapy should start with a dose of 0.1-0.2 mg per day and should be slowly increased according to individual patient requirements. The minimum effective dose should be used. The maintenance dose in these patients seldom exceeds 0.5 mg per day.
Acute overdosage could lead initially to hypoglycaemia and subsequently to hyperglycaemia.
Long-term overdosage could result in signs and symptoms consistent with the known effects of human growth hormone excess.
3 years.
Chemical and physical in-use stability has been demonstrated for 4 weeks at 2°C-8°C.
From a microbiological point of view, once reconstituted, the product may be stored for 4 weeks at 2°C-8°C. Other in-use storage times and conditions are the responsibility of the user.
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/pre-filled pen in the outer carton in order to protect from light.
After reconstitution:
Store in a refrigerator (2°C–8°C). Do not freeze. Keep the two-chamber cartridge/pre-filled pen in the outer carton in order to protect from light. For storage conditions of the reconstituted medicinal product, see section 6.3.
Powder and 1 ml solvent in a two-chamber glass cartridge (type I glass) separated by a rubber plunger (bromobutyl). The cartridge is sealed at one end with a rubber disc (bromobutyl) and an aluminium cap and at the other end by a rubber stopper (bromobutyl). The two-chamber cartridge is supplied for use in a re-usable injection device GENOTROPIN Pen, or reconstitution device, GENOTROPIN Mixer or sealed in a disposable multidose pre-filled pen, GoQuick.
The GENOTROPIN Pens are colour coded, and must be used with the matching colour coded GENOTROPIN two-chamber cartridge to give the correct dose. The GENOTROPIN Pen 5.3 (blue) must be used with GENOTROPIN 5.3 mg cartridge (blue).
The 5.3 mg pre-filled pen GoQuick is colour coded blue.
1x5.3 mg, 5x5.3 mg, 1x5.3 mg pre-filled pen, 5x5.3 mg pre-filled pens.
Not all pack sizes may be marketed.
Only reconstitute the powder with the solvent supplied.
Two-chamber cartridge: The solution is prepared by screwing the reconstitution device or injection device or GoQuick pre-filled pen sections together so that the solvent will be mixed with the powder in the two chamber cartridge. Gently dissolve the powder with a slow, swirling motion. Do not shake vigorously, this might cause denaturation of the active substance. The reconstituted solution is almost colourless or slightly opalescent. The reconstituted solution for injection is to be inspected prior to use and only clear solutions without particles should be used.
Comprehensive instructions for the preparation and administration of the reconstituted Genotropin product are given in the package leaflet, section 3, “Injecting genotropin” and in the relevant Instructions for Use provided with the device being used.
When using an injection device the injection needle should be screwed on before reconstitution.
Disposal instructions: Any unused product or waste material should be disposed of in accordance with local requirements. Empty GoQuick pre-filled pens should never be refilled and must be properly discarded.
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