INDICATIONS

Repatha® is 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 at increased risk for these events... READ MORE

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*The data were taken from The Institute for Health Metrics and Evaluation’s Global Burden of Disease Study. The open source data were used to determine the incidence of new clinical ASCVD cases, defined as: ischemic heart disease, stroke, ischemic stroke, and peripheral artery disease.

Retrospective patient study from IQVIA using an anonymized patient claims data set encompassing nearly 5.4 million patients who experienced Ml and met criteria for VHR ASCVD. Data set from January 1, 2018, to December 31, 2022. 17.1% of patients were treated with low-to-moderate-intensity statin ± ezetimibe, 40.4% high-intensity statin ± ezetimibe, and 44.2% untreated with lipid-lowering therapy. LDL-C levels for this analysis were available for 441,736 VHR ASCVD patients following their most recent MI.

A retrospective cohort study of 16,344 patients 19 years of age or older with a history of major ASCVD events using data from the MarketScan database. 5,919 patients had symptomatic PAD as their history of a major ASCVD event. Patients were followed from January 1, 2016 through December 31, 2017 for recurrent ASCVD events. Major ASCVD events included recent ACS, history other than a recent ACS, history of ischemic stroke, and symptomatic PAD.

ACS = acute coronary syndrome; ADA = American Diabetes Association; ASCVD = atherosclerotic cardiovascular disease; BMI = body mass index; CAC = coronary artery calcium; CKD = chronic kidney disease; CV = cardiovascular; CVD = cardiovascular disease; IQVIA = IMS Quintiles Virtual Information Access; LDL-C = low-density lipoprotein cholesterol; MACE = major adverse cardiac events; MI = myocardial infarction; PAD = peripheral artery disease; VHR = very high risk.

References: 1. Baigent C, Blackwell L, Emberson J, et al. Cholesterol Treatment Trialists’ (CTT) Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010;376:1670-1681. 2. Data on file, Amgen; 2024. 3. Virani SS, Alonso A, Benjamin EJ, et al. Heart disease and stroke statistics—2020 update: a report from the American Heart Association. Circulation. 2020;141(9):e139-e596. 4. Data on file, Amgen; 2023. 5. Lloyd-Jones DM, Morris PB, Ballantyne CM, et al. 2022 ACC Expert Consensus Decision Pathway on the Role of Nonstatin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2022;80:1366-1418. 6. Bhatt DL, Eagle KA, Ohman EM, et al. Comparative determinants of 4-year cardiovascular event rates in stable outpatients at risk of or with atherothrombosis. JAMA. 2010;304:1350-1357. 7. American Diabetes Association. Standards of medical care in diabetes—2024. Diabetes Care. www.professional.diabetes.org/standards-of-care. Accessed October 28, 2025. 8. American Diabetes Association. Standards of medical care in diabetes—2025. Diabetes Care. ada.silverchair-cdn.com/ada/content_public/journal/care/issue/48/supplement_1/7/standards-of-care-2025.pdf. Accessed October 19, 2025. 9. Repatha® (evolocumab) Prescribing Information, Amgen. 10. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019;73:e285-e350. 11. Muntner P, Orroth KK, Mues KE, et al. Evaluating a simple approach to identify adults meeting the 2018 AHA/ACC cholesterol guideline definition of very high risk for atherosclerotic cardiovascular disease. Cardiovasc Drugs Ther. 2022;36:475-481.

Important Safety Information

Contraindication: Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in Repatha®. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha®.

Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, have been reported in patients treated with Repatha®. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with Repatha®, treat according to the standard of care, and monitor until signs and symptoms resolve.

Adverse Reactions in Primary Hypercholesterolemia: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.

From a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha®-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. Hypersensitivity reactions occurred in 5.1% and 4.7% of Repatha®-treated and placebo-treated patients, respectively. The most common hypersensitivity reactions were rash (1.0% versus 0.5% for Repatha® and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).

Adverse Reactions in the FOURIER Cardiovascular Outcomes Trial: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: diabetes mellitus (8.8% Repatha®, 8.2% placebo), nasopharyngitis (7.8% Repatha®, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha®, 4.8% placebo).

Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients treated with Repatha® compared with 7.7% in patients that received placebo.

Immunogenicity: Repatha® is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity with Repatha®.

Indications

Repatha® is 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 at increased risk for these events.
  • As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia and in adults with heterozygous familial hypercholesterolemia (HeFH)

Please see full Prescribing Information.

Important Safety Information