INDICATIONS AND IMPORTANT SAFETY INFORMATION
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.
Study Design: VESALIUS-CV was a phase 3 randomized, double-blind, placebo-controlled, global clinical trial evaluating the impact of evolocumab on major cardiovascular events in patients without a prior MI or stroke at high CV risk. Enrolled patients had ≥ 1 of the following disease categories: CAD, atherosclerotic CeVD, PAD, high-risk DM (defined as diabetes that is long-standing (≥10 years), complicated by microvascular disease, or daily insulin use) and fit one or more additional high-risk criteria (including but not limited to age ≥65 and current tobacco use). Patients were on stable, standard lipid lowering therapy at baseline with LDL-C ≥90 mg/dL, non-HDL-C ≥120 mg/dL, or ApoB ≥80 mg/dL. Median duration of follow-up was 4.6 years and median LDL-C at baseline was 122 mg/dL. Dual primary endpoints included 3-point MACE (time to first occurrence of composite of MI, ischemic stroke, or CHD death) and 4-point MACE (time to first occurrence of composite of MI, ischemic stroke, CHD death, or any ischemia-driven revascularization).1,3
ApoB = apolipoprotein B; CAD = coronary artery disease; CeVD = cerebrovascular disease; CHD = coronary heart disease; CV = cardiovascular; DM = diabetes mellitus; HDL-C = high-density lipoprotein cholesterol; LDL-C = low-density lipoprotein cholesterol; MACE = major adverse cardiac events; MI = myocardial infarction; PAD = peripheral artery disease.
References: 1. Amgen. Press release. Amgen's Repatha® cuts risk of first major adverse cardiovascular events by 25% in landmark phase 3 VESALIUS-CV trial. November 8, 2025. www.amgen.com/newsroom/press-releases/2025/11/amgens-repatha-cuts-risk-of-first-major-adverse-cardiovascular-events-by-25-in-landmark-phase-3-vesaliuscv-trial. Accessed November 10, 2025. 2. Bohula EA, Marston NA, Bhatia AK, et al. Evolocumab in patients without a previous myocardial infarction or stroke. N Engl J Med. Published online November 8, 2025. doi:10.1056/NEJMoa2514428.
3. Bohula EA, Marston NA, Ruzza A, et al. Rationale and design of the effect of evolocumab in patients at high cardiovascular risk without prior myocardial infarction or stroke (VESALIUS-CV) trial. Am Heart J. 2024;269:179-190.
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