PRALUENT indication

Primary hypercholesterolaemia and mixed dyslipidaemia²

PRALUENT^® is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia,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 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.

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 PRALUENT 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.

Adapted from PRALUENT^®Summary of Product Characteristics.
*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