What is PRALUENT®?
PRALUENT®: a powerful PCSK9i that ticks all the boxes1–4
PRALUENT is a PCSK9i that reduces the levels of LDL-C in the blood.2 It is a fully human IgG1 monoclonal antibody that works by inhibiting the binding of PCSK9 to LDL- receptors. As a result, PRALUENT increases the number of LDL-receptors available to clear LDL, thereby lowering LDL-C levels.2 Elevated LDL-C levels have been significantly associated with cardiovascular disease such as heart attacks and strokes.1
Praluent Indication
Primary hypercholesterolaemia and mixed dyslipidaemia1
PRALUENT® is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients 8 years of age and older with heterozygous familial hypercholesterolaemia (HeFH) as an adjunct to diet:
- in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,
- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
Established atherosclerotic cardiovascular disease1
PRALUENT® 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.
Dosing information
Adults2
Prior to initiating PRALUENT 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 PRALUENT 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.
HeFH in paediatric patients 8 years of age and older:2
| 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 evry 2 weeks |
| 50 kg or more | 300 mg once every 4 weeks | 150 mg once every 2 weeks |
Adapted from PRALUENT® Summary of Product Characteristics. 2023.2
* Lipid levels can be assessed 8 weeks after treatment intiation or titration and dose adjusted accordingly.2
If a dose is missed, the dose should be administered as soon as possible and thereafter, dosing should be resumed on the original schedule.
Mechanism of action
PRALUENT increases the number of LDL receptors, which thereby reduces LDL-cholesterol levels. Here’s how:2
- 1
PCSK9 is a regulator of LDL receptor expression on the surface of hepatocytes. Circulating PCSK9 binds to LDL-receptors with high affinity.
- 2
When circulating LDL binds to the LDL-receptor-PCSK9-complex, the complex undergoes endocytosis into clathrin-coated vesicles in the hepatocyte.
- 3
With PCSK9 bound to the LDL-receptor, the entire complex is targeted for lysosomal degradation, resulting in LDL-receptor degradation.
- 4
PCSK9 decreases the expression of surface LDL-receptors, making LDL-receptors available on the liver cell surface to bind circulating LDL-cholesterol, which causes circulating LDL-cholesterol levels to rise.
- 5
With a high affinity and specificity to PCSK9, PRALUENT, a fully human IgG1 monoclonal antibody, inhibits the binding of PCSK9 to LDL-receptors. As a result, PRALUENT increases the number of LDL-receptors available to clear LDL, lowering LDL-cholesterol levels.
More information
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Why choose PRALUENT?
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How to use PRALUENT?
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Indication, Dosing, and Footnotes
Primary hypercholesterolaemia and mixed dyslipidaemia2
PRALUENT® is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients 8 years of age and older with heterozygous familial hypercholesterolaemia (HeFH) as an adjunct to diet:2
- in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,
- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
Established atherosclerotic cardiovascular disease2
PRALUENT® 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.
Adults2
Prior to initiating PRALUENT® 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 PRALUENT® 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.
HeFH in paediatric patients 8 years of age and older:2
| 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 |
Adapted from PRALUENT® Summary of Product Characteristics. 2023.2
* Lipid levels can be assessed 8 weeks after treatment intiation or titration and dose adjusted accordingly.2
If a dose is missed, the dose should be administered as soon as possible and thereafter, dosing should be resumed on the original schedule.
*62.7% LDL-C reduction compared to placebo at 4 months in ODYSSEY OUTCOMES trial.1
†MACE: primary composite endpoint of CHD death, non-fatal myocardial infarction, fatal and non-fatal ischaemic stroke, or unstable angina requiring hospitalisation. HR 0.85 (95% CI 0.78, 0.93), P=0.0003.1,2
‡With only nominal statistical significance by hierarchical testing; HR 0.85 (95% Cl 0.73, 0.98), P=0.0261.1,2
CHD = coronary heart disease; CI = confidence interval; HR = hazard ratio; LDL = low-density lipoprotein; LDL-C = low-density lipoprotein cholesterol; MACE = major adverse cardiovascular event; PCSK9 = proprotein convertase subtilisin/kexin type 9; PCSK9i = proprotein convertase subtilisin/kexin type 9 inhibitor.
-
Schwartz GG, Steg PG, Szarek M, et al. Alirocumab and cardiovascular outcomes after acute coronary syndrome. N Engl J Med. 2018;379(22):2097–2107.
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PRALUENT (alirocumab) Summary of Product Characteristics. Paris, France: sanofi-aventis groupe; December 2023.
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Frias JP, Koren MJ, Loizeau V, et al. The SYDNEY device study: a multicenter, randomized open-label usability study of a 2-mL alirocumab autoinjector device. Clin Ther. 2020;42(1):94–107.
