Established atherosclerotic cardiovascular disease

Active Ingredient: Alirocumab

Indication for Alirocumab

Population group: only adults (18 years old or older)
Therapeutic intent: Adjunct intent

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:

  • in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,
  • alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

For this indication, competent medicine agencies globally authorize below treatments:

75-150 mg once every 2 weeks

Route of admnistration

Subcutaneous

Defined daily dose

75 - 150 mg

Dosage regimen

From 75 To 150 mg once every 14 day(s)

Detailed description

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.

Dosage considerations

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.

150-300 mg once every 4 weeks

Route of admnistration

Subcutaneous

Defined daily dose

150 - 300 mg

Dosage regimen

From 150 To 300 mg once every 28 day(s)

Detailed description

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.

Dosage considerations

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.

Active ingredient

Alirocumab

Alirocumab is a fully human IgG1 monoclonal antibody that binds with high affinity and specificity to proprotein convertase subtilisin kexin type 9 (PCSK9). PCSK9 binds to the low-density lipoprotein receptors (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver. LDLR is the primary receptor that clears circulating LDL, therefore the decrease in LDLR levels by PCSK9 results in higher blood levels of LDL-C. By inhibiting the binding of PCSK9 to LDLR, alirocumab increases the number of LDLRs available to clear LDL, thereby lowering LDL-C levels.

Read more about Alirocumab

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