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Safety Profile | Repatha® (evolocumab)
INDICATIONS

Repatha® is indicated:

  • In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization... READ MORE

    • For US healthcare professionals

    Add Repatha®: A Proven Safety Profile1

    Long-Term Safety Data Consistent With the Established Safety Profile in Fourier1,2,†

    8.4 Years Icon8.4-years-icon

    FOURIER-OLE is the longest trial of PCSK9i mAb to date, with some Repatha® patients followed continuously for up to 8.4 years across FOURIER and FOURIER-OLE3

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    No new safety signals were detected, and the incidence of serious AEs did not increase over time. The incidence of serious AEs was similar in patients achieving very low LDL-C levels (<20 mg/dL) and those with higher LDL-C1,3

    0.1% Icon0.1% Icon

    Discontinuation rate due to AEs attributed to Repatha® during FOURIER-OLE was 0.1%1

    FOURIER open-label extension study (FOURIER-OLE): Open-label extension of FOURIER trial. Analyses were pooled across the two OLE studies. 6,635 patients received Repatha® 140 mg every 2 weeks or 420 mg once a month (3,355 randomized to Repatha®, 3,280 to placebo in the parent trial). Median time on therapy was 7.1 years for those originally randomized to Repatha® (evolocumab) and 5 years for those originally randomized to placebo in the parent trial. The primary endpoint was the subject incidence of treatment-emergent events.

    Repatha® Has a Demonstrated Safety Profile in Over 27,000 Patients in a Median of 2.2 Years2,4

      Repatha® + statin N=13,784 Median achieved LDL-C‡ 26 mg/dL1 Statin + placebo N=13,780 Median achieved LDL-C‡ 89 mg/dL1
    Number of patients n=13,769 n=13,756
    Adverse events (% of patients)
    Diabetes 8.8 8.2
    Adjudicated case of new-onset diabetes 8.1 7.7
    Nasopharyngitis 7.8 7.4
    Upper respiratory tract infection 5.1 4.8
    Muscle-related event 5.0 4.8
    Allergic reaction 3.1 2.9
    Injection-site reaction 2.1 1.6
    Cataract 1.7 1.8
    Neurocognitive event 1.6 1.5
    Rhabdomyolysis 0.1 0.1

    Hemorrhagic stroke: 0.21% statin + Repatha® (n=13,784), 0.18% statin + placebo (n=13,780)§

    Brain Cognitive Function IconBrain Cognitive Function Icon

    Lowering LDL-C With Repatha® Did Not Impair Cognitive Function4

    EBBINGHAUS studied 1,974 patients from the Repatha® CV Outcomes Trial4

    • Patients were assessed using neuropsychological function tests over a median follow-up of 19 months4
    • Study concluded noninferiority in select cognitive function domains was observed between Repatha® (evolocumab) and placebo when added to statin4

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    *Threshold for very high-risk patients.

    †The 2022 ACC Consensus Decision Pathway (referred herein as ACC Consensus Pathway) was designed to address current gaps in care for LDL-C lowering to reducing ASCVD risk. This effort relies extensively on the evidence established by the 2013 ACC/AHA and 2018 AHA/ACC/Multisociety cholesterol guidelines, and provides further recommendations regarding the use of newer nonstatin therapies. It should be noted that this process did not involve formal systematic reviews, grading of evidence, or synthesis of evidence. The goal was to provide practical guidance for situations not covered by the previously published guidelines until the next round of formal review of scientific evidence.

    ‡Median LDL-C achieved at 48 weeks.

    §The total number of patients were 8,337 in the Repatha® + statin group and 8,339 in the placebo + statin group because patients with prevalent diabetes at the start of the trial were excluded.2

    References: 1. O’Donoghue ML, Giugliano RP, Wiviott SD, et al. Long-term evolocumab in patients with established atherosclerotic cardiovascular disease. Circulation. 2022;146:1109-1119. doi:10.1161/CIRCULATIONAHA.122.061620 2. Sabatine MS, Giugliano RP, Keech AC, et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376(18):1713-1722. 3. Gaba P, O’Donoghue ML, Park J-G, et al. Association between achieved low-density lipoprotein cholesterol levels and long-term cardiovascular and safety outcomes: an analysis of FOURIER-OLE [published online ahead of print February 13, 2023]. Circulation. doi:10.1161/CIRCULATIONAHA.122.063399 4. Repatha® (evolocumab) prescribing information, Amgen.

    Important Safety Information

    Contraindications: 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 Hyperlipidemia: 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 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:

    • In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization.
    • 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.

    Please see full Prescribing Information.

    Important Safety Information

    Contraindications: 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®.

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