Pushtronexsystemupdate

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. Today there are 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)
140 mg/mL single-dose prefilled syringe

We plan to discontinue the Repatha^® Pushtronex^® June 30th, 2024, followed by the pre-filled syringe in mid-2025. All patients should transition to another device presentation, preferably SureClick^®, by Q3 2024.

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.

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 your patients:

Patient Next Steps Next Steps TearPad
Repatha^® SureClick^® 1-Page Injection Overview
Repatha^® website: https://www.repatha.com/injection

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 patients with a latex allergy, our current recommendation is to continue utilizing the Pushtronex^® System as the needle shield inside the orange cap of the SureClick^® autoinjector contains dry natural rubber. For HOFH patients, our current recommendation is to continue utilizing the Pushtronex^® System to deliver the 420 mg dose. Additional details closer to the discontinuation date will be provided, offering clarification on a long-term solution for these patients. Please refer to the Repatha Prescribing information for further 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^®.

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.