What is the indication for Repatha (Evolocumab) injections?

From the Guidelines

Repatha (evolocumab) injections are indicated for lowering LDL cholesterol in patients with established atherosclerotic cardiovascular disease or familial hypercholesterolemia who need additional LDL reduction beyond what statins can provide. The medication is typically administered as a subcutaneous injection of 140 mg every 2 weeks or 420 mg once monthly, as demonstrated in the FOURIER trial, which showed a 59% reduction in LDL cholesterol from a median of 92 to 30 mg/dL in the treatment arm 1. This reduction in LDL cholesterol has been associated with a significant decrease in major cardiovascular events, including cardiovascular death, myocardial infarction, and stroke, as seen in the FOURIER trial and the ODYSSEY OUTCOMES trial 1.

Key Points

• Repatha works by inhibiting PCSK9, a protein that regulates LDL receptor recycling, thereby increasing the number of LDL receptors on liver cells and enhancing clearance of LDL cholesterol from the bloodstream.
• The FOURIER trial demonstrated that evolocumab reduced the composite outcome of cardiovascular death, MI, stroke, hospitalization for angina, or revascularization by 15% compared to placebo 1.
• The ODYSSEY OUTCOMES trial showed that alirocumab, another PCSK9 inhibitor, reduced the composite primary endpoint of death from CHD, nonfatal MI, fatal or nonfatal ischemic stroke, or unstable angina requiring hospital admission by 15% compared to placebo 1.
• Patients should be counseled that Repatha requires refrigeration before use but should be allowed to warm to room temperature for 30 minutes before injection.
• Common injection sites include the abdomen, thigh, or upper arm.
• Side effects are generally mild and may include injection site reactions, nasopharyngitis, and upper respiratory tract infections.
• Patients should continue their other lipid-lowering therapies as prescribed while using Repatha.

Administration and Monitoring

• Repatha is administered via subcutaneous injection, and patients should be instructed on proper injection technique.
• Patients should be monitored for signs of infection, such as redness, swelling, or tenderness at the injection site.
• Lipid profiles should be monitored regularly to assess the effectiveness of Repatha therapy.

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 (1) 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 (1) 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 (1) 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 (1)

The indications for Repatha injections are:

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

From the Research

Indications for Repatha Injections

The indications for Repatha injections, which contain the active ingredient evolocumab, are as follows:

• Treatment of hypercholesterolemia in patients with heterozygous (HeFH) and homozygous (HoFH) familial hypercholesterolemia 3, 4, 5, 6, 7
• Reduction of low-density lipoprotein cholesterol (LDL-C) levels in patients with primary hypercholesterolemia or mixed dyslipidemia, particularly in those unable to reach LDL-C goals despite treatment with statins with or without other lipid-lowering therapies, and in patients who do not tolerate or are not able to receive statins 4
• Treatment of patients with HoFH and severe HeFH who are on stable lipid-lowering therapy 6

Patient Populations

Repatha injections are indicated for use in the following patient populations:

• Adults and children aged 12 years and older with HoFH 5, 6
• Adults with HeFH 3, 4, 7
• Patients with primary hypercholesterolemia or mixed dyslipidemia who are unable to reach LDL-C goals despite treatment with statins with or without other lipid-lowering therapies 4

Dosage and Administration

Repatha injections are administered subcutaneously at a dose of 140 mg every 2 weeks or 420 mg once per month 3, 4, 5, 6, 7