Single-Dose Prefilled Autoinjector
successfully administer at home with the Repatha® SureClick® device.2,†
Supplemental injection support is available for patients who need assistance.2,‡
Repatha® can be injected in up to 15 seconds with the Repatha® SureClick® device. That’s just 6.5 minutes per year.§
After receiving proper training and referring to the Instructions for Use, your Repatha® patients can reference this video for additional injection support.
Single-dose on-body infusor with prefilled cartridge system provides patients another option to administer Repatha®.
*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.
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®.
Repatha® is indicated: