What is the indication for Repatha (Evolocumab)?

Medical Advisory BoardAll articles are reviewed for accuracy by our Medical Advisory Board
DS

Dainyal Siddiqui, MD

Internal Medicine

MJ

Manuel Jimenez, MD

Cardiology

FP

Franz Pierre-Louis, MD

Infectious Disease

Article Review Status
Submitted
Under Review
Approved

Last updated: April 18, 2025 • View editorial policy

From the Guidelines

Repatha (evolocumab) is recommended as an adjunct to maximally tolerated statin therapy for patients with established cardiovascular disease and LDL-C levels ≥70 mg/dL, due to its significant reduction in major adverse cardiovascular events and LDL-C levels, as demonstrated in the FOURIER trial 1. The standard dosage of Repatha is 140 mg injected subcutaneously every two weeks or 420 mg once monthly. Key benefits of Repatha include:

  • Significant reduction in LDL-C levels, with a median reduction of 59% at 48 weeks 1
  • Reduction in major adverse cardiovascular events, with a hazard ratio of 0.80 (95% CI: 0.73-0.88) and an absolute risk reduction of 1.5% 1
  • Improvement in other lipid parameters, including non-HDL-C, lipoprotein(a), and triglycerides 1 Common side effects of Repatha include:
  • Injection site reactions, which occurred in 2.1% of patients in the FOURIER trial 1
  • Upper respiratory infections and flu-like symptoms It is essential to continue any prescribed statin therapy alongside Repatha and maintain heart-healthy lifestyle changes. Regular blood tests will be needed to monitor cholesterol levels and adjust treatment as necessary. The FOURIER trial demonstrated that Repatha is effective in reducing major adverse cardiovascular events in patients with established cardiovascular disease, including those with peripheral artery disease and high C-reactive protein levels 1. Overall, Repatha is a valuable addition to the treatment of patients with high cholesterol and established cardiovascular disease, and its use should be considered in patients who require additional LDL-C lowering beyond maximally tolerated statin therapy.

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 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 Indications: Repatha (evolocumab) is indicated for:

  • Reducing the risk of major adverse cardiovascular events in adults with established cardiovascular disease 2
  • Reducing LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH) 2
  • Reducing LDL-C in pediatric patients aged 10 years and older with HeFH 2
  • Reducing LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH) 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.
  • It is administered subcutaneously at a dosage of 140 mg every 2 weeks or 420 mg once monthly 3.

Efficacy in Reducing LDL-C Levels

  • Evolocumab has been shown to be effective in reducing LDL-C levels in patients with primary hypercholesterolemia or mixed dyslipidemia, with treatment differences ranging from -54.8 to -76.3% compared to placebo 3.
  • It has also been effective in reducing LDL-C levels in patients with heterozygous familial hypercholesterolemia, with a treatment difference of approximately 30% compared to placebo 3.
  • In combination with statin therapy, evolocumab has been shown to reduce LDL-C levels by 61% compared to standard therapy alone 4.

Comparison with Other Lipid-Lowering Therapies

  • Evolocumab has been compared to ezetimibe, with evolocumab reducing LDL-C levels by 53-56% from baseline, while ezetimibe reduces LDL-C levels by approximately 18% when used alone 5.
  • The combination of evolocumab, ezetimibe, and statin therapy has been shown to have an improved lipid-lowering effect compared to monotherapy or dual therapy 5.

Safety and Tolerability

  • Evolocumab has been generally well-tolerated, with adverse events occurring at a similar frequency to placebo or standard therapy alone 6, 4.
  • The most common adverse events reported in evolocumab-treated patients include back pain, arthralgia, headache, muscle spasms, and pain in extremity 6.
  • Neurocognitive events have been reported more frequently in the evolocumab group, but the risk of adverse events, including neurocognitive events, did not vary significantly according to the achieved level of LDL cholesterol 4.

Cardiovascular Event Reduction

  • Evolocumab has been shown to reduce the incidence of cardiovascular events, including death, myocardial infarction, unstable angina, coronary revascularization, stroke, transient ischemic attack, and heart failure, with a hazard ratio of 0.47 compared to standard therapy alone 4.
  • The reduction in cardiovascular events has been observed in patients with high and very high risk for secondary atherosclerotic cardiovascular disease (ASCVD) 7.

References

3
Research

Evolocumab: A Review in Hyperlipidemia.

American journal of cardiovascular drugs : drugs, devices, and other interventions, 2016

Related Questions

Is there an association between Repatha (Evolocumab) and new onset tremors?
Which statin, pravastatin or rosuvastatin (Repatha is a monoclonal antibody, not a statin, but assuming the patient is on Repatha and an oral statin is considered), is associated with fewer muscle aches in a patient taking evolocumab (Repatha)?
Should a patient with multivessel atherosclerosis on a statin (HMG-CoA reductase inhibitor) also take Repatha (evolocumab)?
Can Repatha (evolocumab) be taken with a statin (HMG-CoA reductase inhibitor)?
Can Repatha (evolocumab) be taken with other medications?
What alternative antibiotic can be used for a 27-year-old female with a dental abscess (tooth abscess) who is allergic to Augmentin (amoxicillin-clavulanate) and did not respond to Amox (amoxicillin)?
What could cause neuromuscular junction disease, white matter brain lesions, and hyperthyroidism in a young African American woman with negative cerebrospinal fluid (CSF) analysis?
What is the efficacy of cyclobenzaprine (a muscle relaxant) for the treatment of trismus (lockjaw)?
Are there alternative methods to increase serotonin levels without using Selective Serotonin Reuptake Inhibitors (SSRIs) or tricyclic antidepressant medication?
What is the diagnosis and treatment for foot cellulitis (infection of the skin and subcutaneous tissues)?
What is the cause of a 29-year-old patient's left-sided arm pain, described as a sharp, numbing sensation, originating at the biceps (biceps brachii) and radiating to the forearm, occurring intermittently?

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

Ask a new Question. Chat with the Guidelines