SOGROYA Solution for injection Ref.[27982] Active ingredients: Somapacitan

Somapacitan should be initiated and monitored by physicians who are appropriately qualified and experienced in the diagnosis and management of patients with growth hormone deficiency (e.g. endocrinologists).

Posology

Table 1. Dose recommendation:

Paediatric GHD

Dose titration

Somapacitan dose may be individualised and adjusted based on growth velocity, adverse reactions, body weight and serum insulin-like growth factor I (IGF-I) concentrations.

Average IGF-I standard deviation score (SDS) levels (drawn 4 days after dosing) can guide dose titration. Dose adjustments should be targeted to achieve average IGF-I SDS levels in the normal range, i.e. between -2 and +2 (preferably close to 0 SDS).

If the IGF-I (SDS) is >2, it should be reassessed after a subsequent somapacitan administration. If the value remains >2, reducing the dose by 0.04 mg/kg/week is recommended. More than one dose reduction may be required in some patients.

In patients who have had the dose reduced but are not growing well, the dose may be gradually increased as tolerated up to a maximum dose of 0.16 mg/kg/week. Dose increments should not exceed 0.02 mg/kg per week.

Treatment evaluation

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-I, hormones, glucose, and lipid levels) and pubertal status. More frequent evaluations should be considered during puberty.

Treatment should be discontinued in patients having achieved final height or near final height, i.e. an annualised height velocity <2 cm/year and a bone age >14 years in girls or >16 years in boys which corresponds to the closure of the epiphyseal growth plates, see section 4.3. Once the epiphyses are fused, patients should be clinically re-evaluated for the need for growth hormone treatment.

When GHD persists after growth completion, growth hormone treatment should be continued to achieve full somatic adult development including lean body mass and bone mineral accrual (for guidance on dosing see recommended dose for adults (Table 1)).

Adult GHD

Dose titration

The somapacitan dose must be individually adjusted for each patient. It is recommended to increase the dose gradually with 2-4 weeks intervals in steps from 0.5 mg to 1.5 mg based on the patients' clinical response and experience of adverse reactions up to a dose of 8 mg somapacitan per week. Serum insulin like growth factor-I (IGF-I) levels (drawn 3-4 days after dosing) can be used as guidance for the dose titration. The IGF-I standard deviation score (SDS) target should aim for the upper normal range not exceeding 2 SDS. IGF-I SDS levels in the target range are usually achieved within 8 weeks of dose titration. Longer dose titration may be necessary in some adult GHD patients (see below and section 5.1).

Treatment evaluation

Using IGF-I SDS as a biomarker for dose titration, the aim is to reach IGF-I SDS levels within the age-adjusted upper reference range (IGF-I SDS upper reference range: 0 and +2) within 12 months of titration. If this target range cannot be achieved within this period, or the patient does not obtain the desired clinical response, other treatment options should be considered.

During somapacitan maintenance treatment, evaluation of efficacy and safety should be considered at approximately 6- to 12-month intervals and may be assessed by evaluating biochemistry (IGF-I-, glucose-, and lipid levels), body composition, and body mass index.

Paediatric and adult GHD

Switching from other growth hormone products

Patients switching from a weekly growth hormone to somapacitan are recommended to continue administration at their once weekly dosing day.

Patients switching from daily human growth hormone to once-weekly somapacitan should choose the preferred day for the weekly dose and inject the final dose of daily treatment the day before (or at least 8 hours before) injecting the first dose of once-weekly somapacitan. Patients should follow the instructions for the dose presented in Table 1.

Oral oestrogen therapy

Females on oral oestrogen-containing therapy may have reduced IGF-I levels and may require dose adjustment of growth hormone to achieve the treatment goal (see section 4.4). In paediatric GHD doses above 0.16 mg/kg/week have not been studied and are not recommended.

Missed dose

Patients who miss a dose are advised to inject once-weekly somapacitan upon discovery as soon as possible, within 3 days after the missed dose, and then resume their usual once-weekly dosing schedule. If more than 3 days have passed, the dose should be skipped and the next dose should be administered on the regularly scheduled day. If two or more doses have been missed, the dose should be resumed on the regularly scheduled day.

Changing the dosing day

The day of weekly injection can be changed as long as the time between two doses is at least 4 days. After selecting a new dosing day, the once weekly dosing should be continued.

Flexibility in dosing time

On occasions when injection at the scheduled dosing day is not possible, once-weekly somapacitan can be administered up to 2 days before or 3 days after the scheduled weekly dosing day as long as the time between two doses is at least 4 days (96 hours). Once-weekly dosing for the next dose could be resumed at the regularly scheduled dosing day.

Special populations

Elderly (60 years or older)

Generally, lower doses of somapacitan may be necessary in older patients. For further information, see section 5.2.

Paediatric population

Limited data on the clinical effects of somapacitan are available in paediatric GHD patients under 3 years of age. Currently available data are described in sections 5.1 and 5.2, but no recommendation on a posology can be made.

Gender

Men show an increasing IGF-I sensitivity over time. This means that there is a risk that men are overtreated. Women, especially those on oral oestrogen, may require higher doses and a longer titration period than men, see sections 5.1 and 5.2. In females using oral oestrogen, it should be considered to change the route of oestrogen administration (e.g. transdermal, vaginal) see section 4.4.

Renal impairment

No adjustment of the starting dose is required for patients with renal impairment. Patients with renal impairment may need lower doses of somapacitan, but since the dose of somapacitan is individually adjusted according to the need of each patient, no further dose adjustment is required, see section 5.2.

Hepatic impairment

No adjustment of the starting dose is required for patients with hepatic impairment. Patients with moderate hepatic impairment may need higher doses of somapacitan, but since the dose of somapacitan is individually adjusted according to the need of each patient, no further dose adjustment is required. No information regarding the use of somapacitan in patients with severe hepatic impairment is available. Caution should be exercised if treating these patients with somapacitan, see section 5.2.

Method of administration

Somapacitan is to be administered once-weekly at any time of the day.

Somapacitan is to be injected subcutaneously in the abdomen, thighs, buttocks or upper arms without dose adjustment.

The injection site should be rotated every week to prevent local lipoatrophy.

Sogroya 5 mg/1.5 mL solution for injection in pre-filled pen: The Sogroya 5 mg/1.5 mL (3.3 mg/mL) pen delivers doses from 0.025 mg (0.0075 mL) to 2 mg (0.6 mL) in increments of 0.025 mg.

Sogroya 10 mg/1.5 mL solution for injection in pre-filled pen: The Sogroya 10 mg/1.5 mL (6.7 mg/mL) pen delivers doses from 0.05 mg (0.0075 mL) to 4 mg (0.6 mL) in increments of 0.05 mg.

Sogroya 15 mg/1.5 mL solution for injection in pre-filled pen: The Sogroya 15 mg/1.5 mL (10 mg/mL) pen delivers doses from 0.10 mg (0.01 mL) to 8 mg (0.8 mL) in increments of 0.10 mg.

For instructions of the medicinal product before administration, see section 6.6.

There is limited clinical experience with overdose of somapacitan.

Based on experience with daily growth hormone treatment, short term overdose with low blood glucose levels initially, followed by high blood glucose levels can occur. These decreased glucose levels have been detected biochemically, but without clinical signs of hypoglycaemia.

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

2 years.

After first opening:

6 weeks. Store in a refrigerator (2°C-8°C).

Do not freeze. Keep away from the freezing element.

Keep Sogroya in the outer carton with the pen cap on to protect from light.

Before and after first opening:

If refrigeration is not possible (e.g. during travelling), Sogroya may be kept temporarily at temperatures up to 30°C for up to a total of 72 hours (3 days). Return Sogroya to the refrigerator again after storage at this temperature. If stored out of refrigeration and then returned to refrigeration, the total combined time out of refrigeration should not exceed 3 days, monitor this carefully. The Sogroya pen should be discarded, if it has been kept up to 30°C for more than 72 hours (3 days) or for any period of time kept above 30°C.

Store in a refrigerator (2°C-8°C). Do not freeze. Keep away from the freezing element.

Keep Sogroya in the outer carton with the pen cap on to protect from light.

For storage conditions after first opening of the medicinal product, see section 6.3.

The pre-filled pen consists of 1.5 mL solution in a glass cartridge (Type I colourless glass) with a plunger made of chlorobutyl rubber and a stopper made of bromobutyl/isoprene rubber sealed with an aluminium cap. The cartridge is contained in a multidose disposable pen made of polypropylene, polyacetal, polycarbonate and acrylonitrile butadiene styrene and in addition two metal springs. The cartridge is permanently sealed in a pen-injector.

Sogroya 5 mg/1.5 mL solution for injection in pre-filled pen: A colour-coded pre-filled pen with the dose button on the pen coloured teal.

Sogroya 10 mg/1.5 mL solution for injection in pre-filled pen: A colour-coded pre-filled pen with the dose button on the pen coloured yellow.

Sogroya 15 mg/1.5 mL solution for injection in pre-filled pen: A colour-coded pre-filled pen with the dose button on the pen coloured rubine red.

Pack sizes of 1 pre-filled pen and multipack of 5 (5 packs of 1) pre-filled pens. Not all pack sizes may be marketed.

The pen is for use by one person only.

Sogroya should not be used if the solution does not appear clear to slightly opalescent, colourless to slightly yellow and free from visible particles.

Sogroya must not be used if it has been frozen.

The cartridge must not be taken out of the pre-filled pen and refilled.

A 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, patients must follow the instructions described in the instructions for use accompanying the package leaflet.

Needles are not included. Sogroya pre-filled pen is designed to be used with disposable needles of a length between 4 mm and 8 mm and a gauge between 30G and 32G.

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