Product License No. 001033
For patients with Heterozygous Familial Hypercholesterolaemia (HeFH) or adult patients with clinical atherosclerotic cardiovascular disease (ASCVD), who are already on maximal tolerated statin, but whose LDL-C level still cannot reach therapeutic target, Repatha can be used as an adjunct to diet.
Clarification statement: Clinical ASCVD is defined as clinical atherosclerotic cardiovascular disease, including acute coronary artery syndrome, history of myocardial infarction, stable or unstable angina, history of revascularization of coronary artery or other arteries, stroke, transient ischemic attack, and peripheral arterial disease suspected to be caused by atherosclerosis, etc.
For adult patients with primary hyperlipidemia (heterozygous familial and non-familial) or mixed dyslipidemia who are statin-intolerant or for whom a statin is contraindicated, Repatha can be used alone or in combination with other lipid-lowering therapies as an adjunct to diet.
Limitations of Use: The effect of Repatha on cardiovascular morbidity and mortality has not yet been determined.
Repatha® Approved Package Insert