Delivers the 140 mg/dL dose subcutaneously in up to 15 seconds
Once a month Repatha®Pushtronex® System
Single-dose on-body infusor with prefilled cartridge
420 mg/3.5 mL subcutaneous injection
Hidden 29-gauge needle
Steady delivery of the 420 mg/3.5 mL dose subcutaneously in up to 5 minutes
of patients successfully administer at home with either device2,*,†
*Patients who reported two full-dose administrations of Repatha® at weeks 4 and 8. Patients received training from healthcare professionals on how to self-administer.2
†Patients used the Pushtronex® system or three autoinjectors for the once-monthly regimen.2
References: 1. Repatha® (evolocumab) prescribing information, Amgen. 2. Dent R, Joshi R, Djedjos CS, et al. Evolocumab lowers LDL-C safely and effectively when self-administered in the at-home setting. SpringerPlus. 2016;5:300.
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
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®.
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of patients successfully administer at home with either device2,*,†