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Connect With A Rep | 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

    Connect With a Repatha® Representative

    Whether you have product-related questions, need resources or support starting a patient on Repatha®, or Repatha® samples, our Repatha® Representatives are here to help you and your office staff.

    Please note: This form is intended for US healthcare professionals only. If you are a Repatha® patient, please visit repatha.com or call 1-844-REPATHA for support.

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    To report an adverse event, please call 1-800-77-AMGEN (1-800-772-6436).

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    By clicking "Submit," you agree to disclose your personal information to Amgen and to be contacted by Amgen and their agents in the future regarding products, services, and/or information related to Repatha®. For more information about Amgen's privacy practices, please visit www.amgen.com/privacy.

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    *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.

    †Data from the placebo arm of the FOURIER trial. CV event compromises, MI, stroke, or CV death.

    ‡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; AU, Agatston units; CABG, coronary artery bypass graft; CAC, coronary artery calcium; IS, ischemic stroke; MI, myocardial infarction; PAD, peripheral arterial disease; PCI, percutaneous coronary intervention; TIA, transient ischemic attack.

    References: 1. 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. doi:10.1161/cir.0000000000000757 2. Salah HM, Minhas AMK, Khan MS, et al. Causes of hospitalization in the USA between 2005 and 2018. Eur Heart J Open. 2021;1(1):oeab001. doi:10.l093/ehjopen/oeab001 3. Punekar RS, Fox KM, Richhariya A, et al. Burden of first and recurrent cardiovascular events among patients with hyperlipidemia. Clin Cardiol. 2015;38(8):483-491. doi:10.1002/clc.22428 4. McKinley EC, Bittner VA, Brown TM, et al. The projected impact of population-wide achievement of LDL cholesterol <70 mg/dL on the number of recurrent events among US adults with ASCVD. Cardiovasc Drugs Ther. 2023;37(1):107-116. doi:10.1007/s10557-021-07268-x 5. Levintow SN, Reading SR, Noshad S, et al. Lipid testing trends before and after hospitalization for myocardial infarction among adults in the United States, 2008-2019. Clin Epidemiol. 2022;14:737-748. doi:10.2147/clep.s361258 6. 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;14:2425-2435. doi:10.2147/tcrm.s180783 7. Sabatine MS, Leiter LA, Wiviott SD, et al. Cardiovascular safety and efficacy of the PCSK9 inhibitor evolocumab in patients with and without diabetes and the effect of evolocumab on glycaemia and risk of new-onset diabetes: a prespecified analysis of the FOURIER randomised controlled trial. Lancet Diabetes Endocrinol. 2017;5(12):941-950. doi:10.1016/S2213-8587(17)30313-3 8. 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(3):475-481. doi:10.1007/s10557-021-07167-1 9. 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(24):e285-e350. doi:10.1016/j.jacc.2018.11.003

    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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