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Dosing and Administration | 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

    REPATHA® CAN BE DOSED FROM THE COMFORT OF HOME OR ON THE GO*

    One Injection. No Titration. Every 2 Weeks.1

    Repatha® SureClick®

    Repatha® SureClick® Pre-Filled Autoinjector

    Single-Dose Prefilled Autoinjector

    • 140 mg/mL subcutaneous injection
    • Hidden 27-gauge needle
    • Steady delivery of the 140 mg/mL dose subcutaneously up to 15 seconds
    INSTRUCTIONS FOR USE
    Quick Reference Guide for Injection
    94%
    of patients

    successfully administer at home with the Repatha® SureClick® device.2,†

    Supplemental injection support is available for patients who need assistance.2,‡

    Up to

    15
    second injection

    Repatha® can be injected in up to 15 seconds with the Repatha® SureClick® device. That’s just 6.5 minutes per year.§

    Injection Instructions

    Every-2-Week Repatha® SureClick® Autoinjector 140 mg/mL

    Duration: 7:27 Minutes

    After receiving proper training and referring to the Instructions for Use, your Repatha® patients can reference this video for additional injection support.

    Once-a-Month Repatha® Pushtronex® System 420 mg/3.5 mL

    Duration: 11:20 Minutes

    Single-dose on-body infusor with prefilled cartridge system provides patients another option to administer Repatha®.

    Repatha® Prefilled Syringe

    A single-dose prefilled syringe is also available.

    SEE WHAT COVERAGE FOR REPATHA® LOOKS LIKE
    LEARN ABOUT THE MECHANISM OF ACTION

    *Repatha® should be stored in the refrigerator (35⁰F to 46⁰F) until the patient is ready to use it. The patient should wait at least 30 minutes for the autoinjector to reach room temperature before injecting. Repatha® can also be stored at room temperature (68⁰F to 77⁰F) in the original box for up to 30 days.1

    †Patients who reported 2 full-dose administrations of Repatha® at weeks 2 and 4 in THOMAS-1 and weeks 4 and 8 in THOMAS-2. Patients received training from healthcare professionals on how to self-administer.

    ‡Amgen® nurse partners can provide patients live (over the phone) supplemental injection support at 1-844-REPATHA.

    §Not inclusive of preparation and time for autoinjector to reach room temperature before injecting.

    References: 1. Repatha® (evolocumab) prescribing information, Amgen. 2. Dent R, et al. SpringerPlus. 2016;5:300.

    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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