Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Ngenla is indicated for the treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone.
Treatment should be initiated and monitored by physicians who are qualified and experienced in the diagnosis and management of paediatric patients with growth hormone deficiency (GHD).
The recommended dose is 0.66 mg/kg body weight administered once weekly by subcutaneous injection.
Each pre-filled pen is capable of setting and delivering the dose prescribed by the physician. Dose may be rounded up or down based on the physician’s expert knowledge of the individual patient needs. When doses higher than 30 mg are needed (i.e. bodyweight >45 kg), two injections have to be administered.
For patients switching from daily growth hormone medicinal products, the weekly therapy with somatrogon may be initiated at a dose of 0.66 mg/kg/week on the day following their last daily injection.
Somatrogon dose may be adjusted as necessary, based on growth velocity, adverse reactions, body weight and serum insulin-like growth factor 1 (IGF-1) concentrations.
When monitoring for IGF-1, samples should always be drawn 4 days after the prior dose. Dose adjustments should be targeted to achieve average IGF-1 standard deviation score (SDS) levels in the normal range, i.e. between -2 and +2 (preferably close to 0 SDS).
In patients whose serum IGF-1 concentrations exceed the mean reference value for their age and sex by more than 2 SDS, the dose of somatrogon should be reduced by 15%. More than one dose reduction may be required in some patients.
Evaluation of efficacy and safety should be considered at approximately 6 to 12 month intervals and may be assessed by evaluating auxological parameters, biochemistry (IGF-1, hormones, glucose levels) and pubertal status. Routine monitoring of serum IGF-1 SDS levels throughout the course of treatment is recommended. More frequent evaluations should be considered during puberty.
Treatment should be discontinued when there is evidence of closure of the epiphyseal growth plates (see section 4.3). Treatment should also be discontinued in patients having achieved final height or near final height, i.e. an annualised height velocity <2 cm/year or a bone age >14 years in girls or >16 years in boys.
Patients should maintain their regular dosing day. If a dose is missed, somatrogon should be administered as soon as possible within 3 days after the missed dose, and then the usual once weekly dosing schedule should be resumed. If more than 3 days have passed, the missed dose should be skipped and the next dose should be administered on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.
The day of weekly administration can be changed if necessary as long as the time between two doses is at least 3 days. After selecting a new dosing day, the once weekly dosing should be continued.
The safety and efficacy of somatrogon in patients over the age of 65 years have not been established.
No data are available.
Somatrogon has not been studied in patients with renal impairment. No dose recommendation can be made.
Somatrogon has not been studied in patients with hepatic impairment. No dose recommendation can be made.
The safety and efficacy of somatrogon in neonates, infants and children less than 3 years of age have not yet been established. No data are available.
Somatrogon is administered by subcutaneous injection.
Somatrogon is to be injected in the abdomen, thighs, buttocks or upper arms. The site of injection should be rotated at each administration. Injections to the upper arms and buttocks should be given by the caregiver.
The patient and caregiver should receive training to ensure understanding of the administration procedure to support self-administration.
If more than one injection is required to deliver a complete dose, each injection should be administered at a different injection site.
Somatrogon is to be administered once weekly, on the same day each week, at any time of the day.
The pre-filled pen delivers doses from 0.2 mg to 12 mg of somatrogon in increments of 0.2 mg (0.01 mL).
The pre-filled pen delivers doses from 0.5 mg to 30 mg of somatrogon in increments of 0.5 mg (0.01 mL).
For instructions on the medicinal product before administration, see section 6.6 and at the end of the package leaflet.
Single doses of somatrogon higher than 0.66 mg/kg/week have not been studied.
Based on experience with daily growth hormone medicinal products, short-term overdose could lead initially to hypoglycaemia and subsequently to hyperglycaemia. Long-term overdose could result in signs and symptoms of gigantism and/or acromegaly consistent with the effects of growth hormone excess.
Treatment of overdose with somatrogon should consist of general supportive measures.
Before first use: 3 years at 2°C to 8°C. Prior to the first use store Ngenla in a refrigerator. The unopened pre-filled pen may temporarily be held for up to 4 hours at temperatures up to 32°C.
After first use: 28 days.
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Keep Ngenla with the pen cap attached in order to protect from light.
Ngenla may be held at room temperature (up to 32°C) for up to 4 hours with each injection for a maximum of 5 times. Return Ngenla to the refrigerator again after each use. Do not expose Ngenla to temperatures above 32°C or leave at room temperature for more than 4 hours with each use. The Ngenla pen should be discarded if it has been used 5 times, if it has been exposed to temperatures higher than 32°C or if it has been removed from the refrigerator for more than 4 hours with each use.
Chemical and physical in-use stability has been demonstrated for 28 days from the date of first use of the pre-filled pen, when the pre-filled pen has been stored at 2°C to 8°C in between each use.
Store in a refrigerator (2°C to 8°C). Do not freeze. Keep Ngenla in the outer carton in order to protect from light.
For storage conditions after first use of the medicinal product, see section 6.3.
This multi-dose disposable pre-filled pen, which consists of a cartridge (Type I clear glass) permanently sealed in a plastic pen, contains 1.2 mL of somatrogon. The cartridge is closed at the bottom with a rubber stopper (Type I rubber closures) shaped as a plunger and at the top with a rubber stopper (Type I rubber closures) shaped as a disc and sealed with an aluminium cap. The pen cap, dose button and label on the pen are coloured lilac.
Pack size of 1 pre-filled pen.
This multi-dose disposable pre-filled pen, which consists of a cartridge (Type I clear glass) permanently sealed in a plastic pen, contains 1.2 mL of somatrogon. The cartridge is closed at the bottom with a rubber stopper (Type I rubber closures) shaped as a plunger and at the top with a rubber stopper (Type I rubber closures) shaped as a disc and sealed with an aluminium cap. The pen cap, dose button and label on the pen are coloured blue.
Pack size of 1 pre-filled pen.
The solution should appear clear and colourless to slightly light yellow solution and be free of particles. Do not inject the medicinal product if it is cloudy, dark yellow, or contains particulate matter. Do not shake, shaking can damage the medicinal product.
Each Ngenla pre-filled pen is for use by a single patient. A Ngenla pre-filled pen must never be shared between patients, even if the needle is changed.
The pre-filled pen should only be used up to 28 days after first use and before the expiry date.
Do not freeze the medicinal product. Do not expose to heat (above 32°C). Do not use Ngenla if it has been frozen or exposed to heat, discard.
The pen may be used straight from the refrigerator. For a more comfortable injection, the pre-filled pen containing the sterile solution of somatrogon may be allowed to reach room temperature up to 32°C for up to 30 minutes. The solution in the pen should be inspected for flakes, particles and colouration. The pen should not be shaken. If flakes, particles or discolouration are observed, the pen should not be used.
The designated injection site should be prepared as instructed in the Instructions for Use. It is recommended to rotate the injection site at each administration. When in use, always replace the pen cap on the pre-filled pen after each injection. Return Ngenla to the refrigerator again after each use. A new needle must always be attached before use. Needles must not be re-used. The injection needle should be removed after each injection and the pen should be stored without a needle attached. This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.
In the event of blocked needles (i.e. liquid does not appear at the needle tip), patients must follow the instructions described in the Instructions for Use accompanying the package leaflet.
Sterile needles are required for administration but are not included. Ngenla can be administered with a needle from 4 mm to 8 mm and 31 or 32G.
Instructions for the preparation and administration of the product are given in the package leaflet and Instructions For Use.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements. If the pre-filled pen is empty, has been exposed to temperatures higher than 32°C, has been removed from the refrigerator for more than 4 hours with each use, has been used 5 times, or it has been more than 28 days after first use, it should be disposed of even if it contains unused medicinal product. A small amount of the sterile somatrogon solution may remain in the pen after all doses have been correctly given. Patients should be instructed not to use the remaining solution, but to properly discard the pen.
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