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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 with established cardiovascular disease.. READ MORE

    • Important Notice for Healthcare Providers: Discontinuation of Repatha® (evolocumab) Pushtronex® System (single-dose on-body infusor with prefilled cartridge) and for latex allergy patients, the addition of prefilled syringe not made with natural rubber latex available January 2025, followed by SureClick® Autoinjector not made with natural rubber latex available April 2025.

    Please direct your patients to Amgen® SupportPlus: A dedicated transition support line through 844-Repatha (1-844-737-2842), prompt 2 to assist with Q&A, process, and new Repatha® prescriptions. Hours: Monday-Friday 8:00 am - 8:00 pm ET.

    Amgen has made the decision to discontinue the Repatha® Pushtronex® System.

    This decision was made globally to uphold the high standards that Amgen has set to enable the most optimal experience for patients with cardiovascular disease and hyperlipidemia.

    As part of our long-term planning, we conducted an evaluation of the device presentations in the US. Historically, there have been 3 device presentations of Repatha®

    • 140 mg/mL single-dose prefilled SureClick® autoinjector
    • 420 mg/3.5 mL single-dose Pushtronex® system (on-body infusor with prefilled cartridge) (discontinued)
    • 140 mg/mL single-dose prefilled syringe

    A new device presentation for Repatha® has been added in the US:

    • 140 mg/mL prefilled single-dose syringe NDC: 72511-0501-01 not made with natural rubber latex. A new prescription is required.

    A limited supply of Pushtronex® system is available for patients with a latex allergy through certain wholesalers. If these patients are unable to fill their Pushtronex® system prescription, they are encouraged to use the new prefilled syringe not made with natural rubber latex until the SureClick® autoinjector not made with natural rubber latex is available (limited supply April 2025 full supply expected by summer 2025).

    Transitioning Patients to a New Device with a Prescription

    There are no concerns about the Repatha® drug product, efficacy, or patient safety. Alternative presentations are available, and Amgen has sufficient product to meet the demand of patients transitioning from the Pushtronex® system.

    The Repatha® SureClick® Autoinjector is still active and available and will be appropriate for most patients.* However, patients will require a new prescription to transition to a new device.

    Pushtronex® System- Discontinued

    Group 85907

    The Repatha® Pushtronex® system has been discontinued.

    420 mg/3.5 mL single dose on-body infusor with prefilled cartridge
    NDC: 72511-0770-01

    SureClick® Autoinjector- Active and Available

    Group 85918

    The Repatha® SureClick® Autoinjector will be appropriate for most patients.* A new prescription is required.

    140 mg/mL single-dose prefilled autoinjector
    NDC: 72511-0760-02

    Next Steps to Support Your Patients

    Amgen is committed to supporting existing Pushtronex® system patients’ transition and has several dedicated services in place, including:

    Amgen® SupportPlus Dedicated Line

    • Please direct your patients to Amgen® SupportPlus: A dedicated transition support line through 844-Repatha (1-844-737-2842), prompt 2 to assist with Q&A, process, and new Repatha® prescriptions.
    • Hours: Monday-Friday 8:00 am - 8:00 pm ET.

    Additional resources can be requested to help facilitate the transition for your patients:

    You and your team might want to know more about the process and the rationale behind this decision. Please review the FAQs document for more information.

    We appreciate your support and collaboration as we make this transition.

    Sincerely,

    Amgen Inc.

    *For homozygous familial hypercholesterolemia (HoFH) patients, our current recommendation is to continue utilizing the Pushtronex® System to deliver the 420 mg dose until supply is depleted. See FAQs and Repatha Prescribing information for further 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 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:

    • To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults with established cardiovascular disease
    • 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

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