Active Ingredient: Alirocumab
Alirocumab is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
The effect of alirocumab on cardiovascular morbidity and mortality has not yet been determined.
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous
75 - 150 mg
From 75 To 150 mg once every 14 day(s)
Prior to initiating alirocumab secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g. nephrotic syndrome, hypothyroidism) should be excluded.
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 patient should administer the injection as soon as possible and thereafter resume treatment on the original schedule.
Alirocumab is injected as a subcutaneous injection into the thigh, abdomen or upper arm.
To administer the 300 mg dose, either one 300 mg injection or two 150 mg injections should be given consecutively at two different injection sites.
It is recommended to rotate the injection site with each injection.
Subcutaneous
150 - 300 mg
From 150 To 300 mg once every 28 day(s)
Prior to initiating alirocumab secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g. nephrotic syndrome, hypothyroidism) should be excluded.
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 patient should administer the injection as soon as possible and thereafter resume treatment on the original schedule.
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