Active Ingredient: Liraglutide
Liraglutide can be used as an adjunct to a healthy nutrition and increased physical activity for weight management in adolescent patients from the age of 12 years and above with:
Treatment with liraglutide should be discontinued and re-evaluated if patients have not lost at least 4% of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or maximum tolerated dose.
* IOTF BMI cut-off points for obesity by sex between 12-18 years (see table 1), in accordance with study design of the Trial 4180.
Table 1. IOTF BMI cut-off points for obesity by sex between 12–18 years:
| Age (years) | BMI corresponding to 30 kg/m² for adults by international cut-off points. | |
|---|---|---|
| Males | Females | |
| 12 | 26.02 | 26.67 |
| 12.5 | 26.43 | 27.24 |
| 13 | 26.84 | 27.76 |
| 13.5 | 27.25 | 28.20 |
| 14 | 27.63 | 28.57 |
| 14.5 | 27.98 | 28.87 |
| 15 | 28.30 | 29.11 |
| 15.5 | 28.60 | 29.29 |
| 16 | 28.88 | 29.43 |
| 16.5 | 29.14 | 29.56 |
| 17 | 29.41 | 29.69 |
| 17.5 | 29.70 | 29.84 |
| 18 | 30.00 | 30.00 |
Liraglutide is indicated as an adjunct to healthy nutrition and increased physical activity for weight management in children from the age of 6 to <12 years with
Treatment with liraglutide should be discontinued and re-evaluated if patients have not lost at least 4% of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or maximum tolerated dose.
* CDC BMI cut-off points for obesity (≥95th percentile) by sex between 6 to <12 years (see table 2), in accordance with study design of the Trial 4392.
Table 2. Cut-off points for BMI (Weight in kg/Height in m²) for obesity (≥95th percentile) by sex for children from 6 and <12 years of age:
| Age (Years) | Obesity BMI ≥95th percentile | |
|---|---|---|
| Males | Females | |
| 6 | 18.41 | 18.84 |
| 6.5 | 18.76 | 19.23 |
| 7 | 19.15 | 19.68 |
| 7.5 | 19.59 | 20.17 |
| 8 | 20.07 | 20.70 |
| 8.5 | 20.57 | 21.25 |
| 9 | 21.09 | 21.82 |
| 9.5 | 21.62 | 22.40 |
| 10 | 22.15 | 22.98 |
| 10.5 | 22.69 | 23.57 |
| 11 | 23.21 | 24.14 |
| 11.5 | 23.73 | 24.71 |
For this indication, competent medicine agencies globally authorize below treatments:
For:
In case that patient weight is > 60 kg
Subcutaneous, 0.6 milligrams liraglutide, once daily, over the duration of 1 week. Afterwards, subcutaneous, 1.2 milligrams liraglutide, once daily, over the duration of 1 week. Afterwards, subcutaneous, 1.8 milligrams liraglutide, once daily, over the duration of 1 week. Afterwards, subcutaneous, 2.4 milligrams liraglutide, once daily, over the duration of 1 week. Afterwards, subcutaneous, 3 milligrams liraglutide, once daily.
For adolescents from the age of 12 to below 18 years old a similar dose escalation schedule as for adults should be applied (see table). The dose should be increased until 3.0 mg (maintenance dose) or maximum tolerated dose has been reached. Daily doses higher than 3.0 mg are not recommended.
Dose escalation schedule:
| Dose | Weeks | |
|---|---|---|
| Dose escalation 4 weeks | 0.6 mg | 1 |
| 1.2 mg | 1 | |
| 1.8 mg | 1 | |
| 2.4 mg | 1 | |
| Maintenance dose | 3.0 mg | |
If a dose is missed within 12 hours from when it is usually taken, the patient should take the dose as soon as possible. If there is less than 12 hours to the next dose, the patient should not take the missed dose and resume the once-daily regimen with the next scheduled dose. An extra dose or increase in dose should not be taken to make up for the missed dose.
Liraglutide is administered once daily at any time, independent of meals. It should be injected in the abdomen, thigh or upper arm. The injection site and timing can be changed without dose adjustment. However, it is preferable that liraglutide is injected around the same time of the day, when the most convenient time of the day has been chosen. Injection sites should always be rotated to reduce the risk of injection site amyloid deposits.
For:
In case that patient weight is ≥ 45 kg
Subcutaneous, 0.6 milligrams liraglutide, once daily, over the duration of 1 week. Afterwards, subcutaneous, 1.2 milligrams liraglutide, once daily, over the duration of 1 week. Afterwards, subcutaneous, 1.8 milligrams liraglutide, once daily, over the duration of 1 week. Afterwards, subcutaneous, 2.4 milligrams liraglutide, once daily, over the duration of 1 week. Afterwards, subcutaneous, 3 milligrams liraglutide, once daily.
For children from the age of 6 to below 12 years old a similar dose escalation schedule as for adults should be applied (see table). The dose should be increased until 3.0 mg (maintenance dose) or maximum tolerated dose has been reached. Daily doses higher than 3.0 mg are not recommended. Liraglutide in children should be initiated by a physician experienced in the management of obesity in children.
Dose escalation schedule:
| Dose | Weeks | |
|---|---|---|
| Dose escalation 4 weeks | 0.6 mg | 1 |
| 1.2 mg | 1 | |
| 1.8 mg | 1 | |
| 2.4 mg | 1 | |
| Maintenance dose | 3.0 mg | |
If a dose is missed within 12 hours from when it is usually taken, the patient should take the dose as soon as possible. If there is less than 12 hours to the next dose, the patient should not take the missed dose and resume the once-daily regimen with the next scheduled dose. An extra dose or increase in dose should not be taken to make up for the missed dose.
Liraglutide is administered once daily at any time, independent of meals. It should be injected in the abdomen, thigh or upper arm. The injection site and timing can be changed without dose adjustment. However, it is preferable that liraglutide is injected around the same time of the day, when the most convenient time of the day has been chosen. Injection sites should always be rotated to reduce the risk of injection site amyloid deposits.
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