Active Ingredient: Evolocumab
Evolocumab is indicated in adults and paediatric patients aged 10 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that patient age in years is ≥ 10, subcutaneous, 420 milligrams evolocumab, once monthly.
Regimen B: In case that patient age in years is ≥ 10 and there is poor response to treatment, subcutaneous, 420 milligrams evolocumab, once monthly, over the duration of 12 weeks. Afterwards, in case that patient age in years is ≥ 10 and there is poor response to treatment, subcutaneous, 420 milligrams evolocumab, once every 2 weeks.
The initial recommended dose is 420 mg once monthly. After 12 weeks of treatment, dose frequency can be up-titrated to 420 mg once every 2 weeks if a clinically meaningful response is not achieved. Patients on apheresis may initiate treatment with 420 mg every two weeks to correspond with their apheresis schedule.
Evolocumab is for subcutaneous injection into the abdomen, thigh or upper arm region. Injection sites should be rotated and injections should not be given into areas where the skin is tender, bruised, red, or hard.
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