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High LDL-C Injection Treatment | 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
  • Your patients with established CVD are at risk for a CV event

    Don’t wait for tomorrow. Act now. Add Repatha® to dramatically lower LDL-C and reduce the risk of MI, stroke, or coronary revascularization.1

    Dr. Janki
    Shah

    >1.7

    million patients

    have received Repatha® worldwide4,‡

    The first year after a patient’s heart attack is critical…because they are at extremely high risk for a recurrent heart attack or stroke. Time is of the essence.– Dr. Shah

    *In a descriptive, retrospective analysis of 186,670 patients with ASCVD with index LDL-C >70 mg/dL (mean index LDL-C of 108 mg/dL). Baseline statin intensity: Among the 75,523 patients with ASCVD treated at baseline, 12.18% were on low statin intensity, 58.4% were on moderate statin intensity, 20.6% were on high statin intensity, and 8.8% were treated with other lipid-lowering agents. Patients were identified between January 1, 2012 and August 31, 2014, using the IQVIA US ambulatory electronic medical record database. Treatment exposure to statin and/or ezetimibe was based on observation of a valid prescription recorded in the EMR database, which does not guarantee that the patient filled the prescription or used the medication.

    Eligibility criteria and program maximums apply. See the full terms and conditions.

    Cumulative post-market exposure estimates from July 2015 through June 2022, on patients that have received at least one dose administration of the product. The number of patients receiving at least one administration is estimated using worldwide unit sales data, prescription claims data, and applying utilization assumptions to calculate the unique number of patients. Sources include Amgen Finance Electronica Data Warehouse, IQVIA prescription claims, and MarketScan claims data. The estimates assume patient self-administration based on filled prescriptions.

    References: 1. Repatha® (evolocumab) prescribing information, Amgen. 2. Chen C-C, Rane PB, Hines DM, Patel J, Harrison DJ, Wade RL. Low-density lipoprotein cholesterol outcomes post-non-PCSK9i lipid-lowering therapies in atherosclerotic cardiovascular disease and probable heterozygous familial hypercholesterolemia patients. Ther Clin Risk Manag. 2018;14:2425-2434. doi:10.2147/tcrm.s180783 3. Data on file, Amgen; [1]; 2022. 4. Data on file, Amgen; [2]; 2023.

    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.