Active Ingredient: Alirocumab
Alirocumab is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A
Subcutaneous, 75 milligrams alirocumab, once every 2 weeks.
Regimen B
Subcutaneous, 150 milligrams alirocumab, once every 2 weeks.
Regimen C
Subcutaneous, 300 milligrams alirocumab, once every 4 weeks.
The usual starting dose for alirocumab is 75 mg administered subcutaneously once every 2 weeks. Patients requiring larger LDL-C reduction (>60%) may be started on 150 mg once every 2 weeks, or 300 mg once every 4 weeks (monthly), administered subcutaneously.
The dose of alirocumab can be individualised based on patient characteristics such as baseline LDL-C level, goal of therapy, and response. Lipid levels can be assessed 4 to 8 weeks after treatment initiation or titration, and dose adjusted accordingly (up-titration or down-titration). If additional LDL-C reduction is needed in patients treated with 75 mg once every 2 weeks or 300 mg once every 4 weeks (monthly), the dosage may be adjusted to the maximum dosage of 150 mg once every 2 weeks.
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.
Adult patients may either self-inject alirocumab, or a caregiver may administer alirocumab, after guidance has been provided by a healthcare professional on proper subcutaneous injection technique.
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