What is the use of Repatha (Evolocumab)?

From the Guidelines

Repatha (evolocumab) is recommended as an adjunct to maximally tolerated statin therapy for patients with established cardiovascular disease and an LDL-C level of ≥70 mg/dL, due to its significant reduction in major adverse cardiovascular events, as demonstrated in the FOURIER trial 1. The standard dose of Repatha is 140 mg injected subcutaneously every two weeks or 420 mg once monthly. This medication works by blocking PCSK9, a protein that prevents the liver from removing LDL cholesterol from the blood, resulting in significant LDL reductions of 50-60% on average, as seen in the FOURIER trial 1. Key benefits of Repatha include:

• Significant reduction in major adverse cardiovascular events, including heart attack, stroke, and coronary revascularization procedures 1
• Reduction in non-HDL-C, lipoprotein(a), and triglycerides, as well as an increase in HDL-C 1
• Similar rates of serious adverse events compared to placebo, with only injection site reactions occurring more frequently with Repatha treatment 1
• No differences in the rates of diabetes mellitus, muscle-related events, or elevations in liver function tests 1
• No signal of harm among patients with an LDL-C level of <10 mg/dL during the study 1 It's essential to note that Repatha is typically prescribed when statins alone are insufficient or not tolerated, and clinical trials have shown it reduces the risk of major adverse cardiovascular events in patients at high cardiovascular risk who need additional cholesterol lowering beyond what statins can provide 1.

From the FDA Drug Label

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) REPATHA is an injectable prescription medicine used: To reduce the risk of major adverse cardiovascular (CV) events, such as death from cardiovascular disease, heart attack, stroke, certain types of chest pain conditions (unstable angina) requiring hospitalization, or certain types of heart surgery, in adults with cardiovascular disease along with diet alone or together with other cholesterol-lowering medicines

• Main Indications:
  • Reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease
  • Reduce LDL-C in adults with primary hyperlipidemia, including 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 HoFH
• Administration: REPATHA is given under the skin (subcutaneously), every 2 weeks or 1 time each month 2 2

From the Research

Repatha (Evolocumab) Overview

• Repatha, also known as evolocumab, is a monoclonal antibody that targets proprotein convertase subtilisin/kexin type 9 (PCSK9) to reduce low-density lipoprotein cholesterol (LDL-C) levels 3, 4.
• It is administered subcutaneously at a dosage of 140 mg every 2 weeks or 420 mg once monthly 3, 4.

Efficacy of Repatha

• Repatha has been shown to be effective in reducing LDL-C levels in patients with primary hypercholesterolemia or mixed dyslipidemia, including those with heterozygous and homozygous familial hypercholesterolemia 3, 4, 5.
• It has also been demonstrated to reduce the incidence of major cardiovascular adverse events by 15% in patients with atherosclerotic cardiovascular disease and residual hypercholesterolaemia despite statin therapy 6.
• Repatha has been shown to reduce LDL-C levels by 50-70% when used in combination with statin therapy 5, 7.

Safety and Tolerance

• Repatha has been well tolerated in clinical trials, with a safety profile similar to that of placebo or active comparators 3, 4, 7.
• The most common adverse events associated with Repatha are injection site reactions, which are generally mild and transient 7.

Patient Selection and Follow-up

• Appropriate candidates for Repatha are individuals at high cardiovascular risk, including those with familial hypercholesterolemia and/or established cardiovascular disease, who are already on statin therapy 5.
• Repatha may also be considered for patients who are statin-intolerant, despite attempting several statins 5.
• Patient willingness to self-inject Repatha and issues concerning third-party coverage should be taken into consideration when prescribing this medication 5.