What is Repatha (evolocumab) and what are its indications?

From the Guidelines

Repatha (evolocumab) is a PCSK9 inhibitor medication used to lower LDL cholesterol levels in the blood, and it is indicated for adults with established cardiovascular disease to reduce the risk of heart attack, stroke, and coronary revascularization procedures, as well as for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL cholesterol. The medication works by blocking the PCSK9 protein, which normally binds to LDL receptors and leads to their degradation; by inhibiting this process, more LDL receptors remain available on liver cells to remove LDL cholesterol from the bloodstream 1. The typical dose is 140 mg injected subcutaneously every two weeks or 420 mg once monthly, and it is generally used when maximum tolerated statin therapy and/or ezetimibe have not adequately controlled LDL cholesterol levels 1. Common side effects include injection site reactions, nasopharyngitis, and upper respiratory tract infections, and the medication is administered via a prefilled autoinjector or syringe and should be stored refrigerated but can be kept at room temperature for up to 30 days 1. Key benefits of Repatha include its ability to significantly reduce LDL cholesterol levels, with studies showing an average reduction of 36-59% when added to maximally tolerated statin therapy 1, and its approval as adjunctive therapy for patients with ASCVD or familial hypercholesterolemia who are receiving maximally tolerated statin therapy but require additional lowering of LDL cholesterol 1.

Some of the key points to consider when prescribing Repatha include:

• The medication is indicated for adults with established cardiovascular disease, HeFH, or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL cholesterol 1
• The typical dose is 140 mg injected subcutaneously every two weeks or 420 mg once monthly 1
• Common side effects include injection site reactions, nasopharyngitis, and upper respiratory tract infections 1
• The medication is administered via a prefilled autoinjector or syringe and should be stored refrigerated but can be kept at room temperature for up to 30 days 1
• Repatha has been shown to significantly reduce LDL cholesterol levels and reduce the risk of cardiovascular events, including heart attack, stroke, and coronary revascularization procedures 1

From the FDA Drug Label

REPATHA is a PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults with established cardiovascular disease as an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C as an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 10 years and older with HeFH, to reduce LDL-C as an adjunct to other LDL-C-lowering therapies in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH), to reduce LDL-C

Repatha (evolocumab) is a PCSK9 inhibitor used to:

• Reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease
• Reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH)
• Reduce LDL-C in pediatric patients aged 10 years and older with HeFH
• Reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH) 2

From the Research

What is Repatha (Evolocumab)

• Repatha (evolocumab) is a monoclonal antibody that targets proprotein convertase subtilisin/kexin type 9 (PCSK9) 3, 4
• It is administered subcutaneously at a dosage of 140 mg every 2 weeks or 420 mg once monthly 3

Indications for Repatha (Evolocumab)

• Primary hypercholesterolemia or mixed dyslipidemia 3, 4
• Heterozygous familial hypercholesterolemia 3, 5
• Homozygous familial hypercholesterolemia 3, 6
• Secondary prevention of atherosclerotic cardiovascular disease in patients with residual hypercholesterolaemia despite statin therapy 7

Patient Populations

• Adults with primary hypercholesterolemia or mixed dyslipidemia 3, 4
• Pediatric patients (10-17 years of age) with heterozygous familial hypercholesterolemia 5
• Patients with homozygous familial hypercholesterolemia, including those <18 years of age 6
• Patients with atherosclerotic cardiovascular disease and residual hypercholesterolaemia despite statin therapy 7

Dosage and Administration

• Subcutaneous injection of 140 mg every 2 weeks or 420 mg once monthly 3
• Patients with homozygous familial hypercholesterolemia may be up-titrated to 420 mg every 2 weeks 6