OMNITROPE Solution for injection Ref.[115550] Active ingredients: Somatropin

Diagnosis and therapy with somatropin should be initiated and monitored by physicians who are appropriately qualified and experienced in the diagnosis and management of patients with growth disorders.

Posology

Paediatric population

The posology and administration schedule should be individualised.

Growth disturbance due to insufficient secretion of growth hormone in paediatric patients

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.

Prader-Willi syndrome, for improvement of growth and body composition in paediatric patients

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 paediatric patients with a growth velocity less than 1 cm per year and near closure of epiphyses.

Growth disturbance due to Turner syndrome

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.

Growth disturbance in chronic renal insufficiency

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 may be needed if growth velocity is too low. A dose correction can be needed after six months of treatment (see section 4.4).

Growth disturbance in short children/adolescents born small for gestational age (SGA)

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.

Dose recommendations in paediatric patients:

Growth hormone deficient adult patients

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 adults 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 insulin-like growth factor (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 the 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 recognized 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 rarely 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 may be reduced.

Special populations

Elderly

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.

Method of administration

The injection should be given subcutaneously and the site varied to prevent lipoatrophy.

For instructions for use and handling see section 6.6.

Symptoms

Acute overdose could lead initially to hypoglycaemia and subsequently to hyperglycaemia.

Long-term overdose could result in signs and symptoms consistent with the known effects of human growth hormone excess.

Omnitrope 5 mg/1.5 ml solution for injection:

2 years

Omnitrope 10 mg/1.5 ml solution for injection:

18 months.

Shelf life after first use:

After first use the cartridge should remain in the pen and has to be kept in a refrigerator (2°C-8°C) for a maximum of 28 days. Store and transport refrigerated (2°C-8°C). Do not freeze. Store in the original pen in order to protect from light.

Unopened cartridge:

Store and transport refrigerated (2°C-8°C). Do not freeze. Store in the original package in order to protect from light.

For storage conditions of the in-use medicinal product, see section 6.3.

1.5 ml of solution in a cartridge (colourless type I glass) with plunger on one side (siliconised bromobutyl), a disc (bromobutyl) and a cap (aluminium) on the other side.

Pack sizes of 1, 5 and 10.

Not all pack sizes may be marketed.

Omnitrope 5 mg/1.5 ml solution for injection is a sterile, ready-to-use solution for subcutaneous injection filled in a glass cartridge.

This presentation is intended for multiple use. It should only be administered with the Omnitrope Pen 5, an injection device specifically developed for use with Omnitrope 5 mg/1.5 ml solution for injection. It has to be administered using sterile, disposable pen needles. Patients and caregivers have to receive appropriate training and instruction on the proper use of the Omnitrope cartridges and the pen from the physician or other suitable qualified health professionals.

Omnitrope 10 mg/1.5 ml solution for injection is a sterile, ready-to-use solution for subcutaneous injection filled in a glass cartridge.

This presentation is intended for multiple use. It should only be administered with the Omnitrope Pen 10, an injection device specifically developed for use with Omnitrope 10 mg/1.5 ml solution for injection. It has to be administered using sterile, disposable pen needles. Patients and caregivers have to receive appropriate training and instruction on the proper use of the Omnitrope cartridges and the pen from the physician or other suitable qualified health professionals.

The following is a general description of the administration process. The manufacturer's instructions with each pen must be followed for loading the cartridge, attaching the injection needle and for the administration.

1. Hands should be washed.

2. If the solution is cloudy or contains particulate matter, it should not be used. The content must be clear and colourless.

3. Disinfect the rubber membrane of the cartridge with a cleansing swab

4. Insert the cartridge into the Omnitrope Pen following the instructions for use provided with the pen.

5. Clean the site of injection with an alcohol swab.

6. Administer the appropriate dose by subcutaneous injection using a sterile pen needle. Remove the pen needle and dispose of it in accordance with local requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.