Sogroya

g. endocrinologists). 5 mg/week 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. 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.

04 mg/kg/week is recommended. More than one dose reduction may be required in some patients. 16 mg/kg/week. 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. 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

8. Use with oral oestrogen Oral oestrogen influences the IGF-I response to growth hormone including somapacitan. g. transdermal-, vaginal hormone products) or use another form of contraception. 2). If a female patient taking somapacitan begins oral oestrogen therapy, the dose of somapacitan may need to be increased to maintain the serum IGF-I levels within the normal age-appropriate range.

5. Skin and subcutaneous tissue disorders When somapacitan is administered at the same site over a longer period of time, local changes in the subcutaneous tissue such as lipohypertrophy, lipoatrophy, and acquired lipodystrophy might occur.

8. Antibodies Antibodies to somapacitan were not observed in adult GHD patients. Few paediatric GHD patients tested positive for somapacitan binding antibodies. None of these antibodies were neutralising and no impact on the clinical effects was observed.

Testing for presence of anti-somapacitan antibodies should be carried out in patients who fail to respond to therapy. Acute critical illness The effect of growth hormone on recovery was studied in two placebo controlled trials involving 522 critical ill adult patients suffering from complications following open heart surgery, abdominal surgery, multiple accidental trauma or acute respiratory failure.

3 or 8 mg growth hormone daily compared to patients receiving placebo, 42% vs 19%. Based on this information, these types of patients should not be treated with somapacitan. As there is no information available on the safety of growth hormone substitution therapy in acutely critical ill patients, the benefits of continued treatment in this situation should be weighed against the potential risks involved.

Growth hormone deficiency in adults is a lifelong disease and needs to be treated accordingly, however, experience in patients older than 60 years and in patients with more than five years of treatment in adult growth hormone deficiency is still limited.

4. Renal impairment No adjustment of the starting dose is required for patients with renal impairment. 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. 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. 025 mg. 05 mg. 10 mg. 6. 1. Somapacitan must not be used when there is any evidence of activity of a tumour. Intracranial tumours must be inactive and antitumour therapy must be completed prior to starting somapacitan therapy.

4. 2. 4). 4 Special warnings and precautions for use Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Adrenocortical insufficiency Introduction of growth hormone treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations.

In patients treated with growth hormone, previously undiagnosed central (secondary) hypoadrenalism may be unmasked and glucocorticoid replacement may be required. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of growth hormone treatment.

It is necessary to monitor patients with known hypoadrenalism for reduced serum cortisol levels and/or for the need of increased doses of glucocorticoid, see section

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)).

4 Adult GHD Dose titration The somapacitan dose must be individually adjusted for each patient. 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. 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.