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 adult patients with growth hormone deficiency (e.g. endocrinologists).

Posology

Starting dose

Table 1. Starting dose recommendation:

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 AGHD 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.

Missed dose

Patients who forget a dose are advised to inject 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.

Special populations

Elderly (≥60 years of age)

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

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 women 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.

Paediatric population

Safety and efficacy of somapacitan in children and adolescents below 18 years have not yet been established. No data are available.

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 or in the thigh. The injection site can be changed without dose adjustment. The injection site should be rotated every week.

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

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 to 4 mg in increments of 0.05 mg (0.0075 mL).

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

Treatment with growth hormone can lead to an acute overdose with low blood glucose levels initially, followed by high blood glucose levels. 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-injector 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-injector coloured yellow.

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 has been tested with 31 Gx6 mm and 32 Gx5 mm disposable needles. Sogroya can be administered with a needle up to a length of 8 mm and as thin as 32 G.

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