PRALUENT (Sanofi-Aventis Australia Pty Ltd)

Primary hypercholesterolaemia

PRALUENT is indicated as an adjunct to diet and exercise to reduce LDL-C in adults with primary (heterozygous familial or non-familial) hypercholesterolaemia in patients with moderate to very high cardiovascular risk:

• In combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with maximum tolerated dose of a statin,
• alone or in combination with other lipid lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated who are unable to reach LDL-C goals.

Prevention of cardiovascular events

PRALUENT is indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke, unstable angina requiring hospitalisation) in adults with established cardiovascular disease, in combination with optimally dosed statins and/or other lipid-lowering therapies (see section 5.1 Pharmacodynamic properties, CLINICAL TRIALS).