Active Ingredient: Alirocumab
Alirocumab is indicated in paediatric patients 8 years of age and older with heterozygous familial hypercholesterolaemia (HeFH) as an adjunct to diet:
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A, in case that patient age in years is ≥ 8 and patient weight is < 50 kg
Subcutaneous, 150 milligrams alirocumab, once every 4 weeks.
Regimen B, in case that patient age in years is ≥ 8 and patient weight is < 50 kg
Subcutaneous, 75 milligrams alirocumab, once every 2 weeks.
Regimen C, in case that patient age in years is ≥ 8 and patient weight is ≥ 50 kg
Subcutaneous, 300 milligrams alirocumab, once every 4 weeks.
Regimen D, in case that patient age in years is ≥ 8 and patient weight is ≥ 50 kg
Subcutaneous, 150 milligrams alirocumab, once every 2 weeks.
| Body weight of patients | Recommended dose | Recommended dose if additional LDL-C reduction is needed* |
|---|---|---|
| Less than 50 kg | 150 mg once every 4 weeks | 75 mg once every 2 weeks |
| 50 kg or more | 300 mg once every 4 weeks | 150 mg once every 2 weeks |
* Lipid levels can be assessed 8 weeks after treatment initiation or titration and dose adjusted accordingly.
If a dose is missed, the dose should be administered as soon as possible and thereafter, dosing should be resumed on the original schedule.
Alirocumab is injected as a subcutaneous injection into the thigh, abdomen or upper arm.
It is recommended to rotate the injection site with each injection.
Alirocumab should not be injected into areas of active skin disease or injury such as sunburns, skin rashes, inflammation, or skin infections.
Alirocumab must not be co-administered with other injectable medicinal products at the same injection site.
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