Active Ingredient: Somapacitan
Somapacitan is indicated for the replacement of endogenous growth hormone (GH) in adults with growth hormone deficiency (AGHD).
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous
1 - 4 mg
From 1 To 4 mg once every 7 day(s)
Starting dose recommendation:
| AGHD population | Recommended starting dose |
|---|---|
| Naïve patients | |
| Adults (18-60 years) Women on oral oestrogen (irrespective of age) Elderly (≥60 years) | 1.5 mg/week 2 mg/week 1 mg/week |
| Patients switching from daily GH medicinal products | |
| Adults (18-60 years) Women on oral oestrogen (irrespective of age) Elderly (≥60 years) | 2 mg/week 4 mg/week 1.5 mg/week |
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.
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.
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.
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.
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.
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