Active Ingredient: Semaglutide
Semaglutide is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with
Treatment with semaglutide should be discontinued and re-evaluated if adolescent patients have not reduced their BMI by at least 5% after 12 weeks on the 2.4 mg or maximum tolerated dose.
* Obesity (BMI ≥95th percentile) as defined on sex- and age-specific BMI growth charts (CDC.gov) (see Table 1).
Table 1. BMI cut-off points for obesity (≥95th percentile) by sex and age for paediatric patients aged 12 and older (CDC criteria):
| Age (years) | BMI (kg/m²) at 95th Percentile | |
|---|---|---|
| Males | Females | |
| 12 | 24.2 | 25.2 |
| 12.5 | 24.7 | 25.7 |
| 13 | 25.1 | 26.3 |
| 13.5 | 25.6 | 26.8 |
| 14 | 26.0 | 27.2 |
| 14.5 | 26.4 | 27.7 |
| 15 | 26.8 | 28.1 |
| 15.5 | 27.2 | 28.5 |
| 16 | 27.5 | 28.9 |
| 16.5 | 27.9 | 29.3 |
| 17 | 28.2 | 29.6 |
| 17.5 | 28.6 | 30.0 |
For this indication, competent medicine agencies globally authorize below treatments:
For:
In case that patient weight is ≥ 60 kg, oral, 0.25 milligrams semaglutide, once weekly, over the duration of 4 weeks. Afterwards, in case that patient weight is ≥ 60 kg, oral, 0.5 milligrams semaglutide, once weekly, over the duration of 4 weeks. Afterwards, in case that patient weight is ≥ 60 kg, oral, 1 milligrams semaglutide, once weekly, over the duration of 4 weeks. Afterwards, in case that patient weight is ≥ 60 kg, oral, 2.4 milligrams semaglutide, once weekly.
For adolescents ages 12 years and above, the same dose escalation schedule as for adults should be applied (see table). The dose should be increased until 2.4 mg (maintenance dose) or maximum tolerated dose has been reached. Weekly doses higher than 2.4 mg are not recommended.
Dose escalation schedule:
| Dose escalation | Weekly dose |
|---|---|
| Week 1–4 | 0.25 mg |
| Week 5–8 | 0.5 mg |
| Week 9–12 | 1 mg |
| Week 13–16 | 1.7 mg |
| Maintenance dose | 2.4 mg |
If a dose is missed, it should be administered as soon as possible and within 5 days after the missed dose. If more than 5 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. If more doses are missed, reducing the starting dose for re-initiation should be considered.
Semaglutide is administered once weekly at any time of the day, with or without meals.
It is to be injected subcutaneously in the abdomen, in the thigh or in the upper arm. The injection site can be changed. It should not be administered intravenously or intramuscularly.
The day of weekly administration can be changed if necessary, as long as the time between two doses is at least 3 days (>72 hours). After selecting a new dosing day, once-weekly dosing should be continued.
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