CardioSource WorldNews - Page 40

For adults with clinical ASCVD on maximally tolerated statin therapy as an adjunct to diet1 REPATHA ® THE FIRST AND ONLY PCSK9 INHIBITOR WITH A SINGLE MONTHLY INJECTION Two dosing options designed with your patients in mind ONCE A MONTH or EVERY 2 WEEKS NEW Repatha® Pushtronex ™ system Repatha® SureClick ® single-use, on-body infusor with prefilled cartridge single-use, prefilled autoinjector Hidden 29-gauge needle2 Hidden 27-gauge needle3 Steady delivery of the 420 mg/3.5 mL dose subcutaneously over 9 minutes2 Delivers the 140 mg/mL dose subcutaneously up to 15 seconds1 Securely adheres to the body so patients can be hands free during administration while they perform moderate activities2 Consider for patients who are comfortable self-injecting with a hand-held device After one push of a button, the on-body device does the work Indication • Repatha® is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (CVD), who require additional lowering of low density lipoprotein cholesterol (LDL-C). • The effect of Repatha on cardiovascular morbidity and mortality has not been determined. ® Important Safety Information • Contraindication: Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to Repatha®. • Allergic reactions: Hypersensitivity reactions (e.g. rash, urticaria) have been reported in patients treated with Repatha®, including some that led to discontinuation of therapy. If signs or symptoms of serious allergic reactions occur, discontinue treatment with Repatha®, treat according to the standard of care, and monitor until signs and symptoms resolve. • Adverse reactions: The most common adverse reactions (> 5% of Repatha®-treated patients and more common than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions. In a 52-week trial, adverse reactions led to discontinuation of treatment in 2.2% of Repatha®treated patients and 1% of placebo-treated patients. The most common adverse reaction that led to Repatha® treatment discontinuation and occurred at a rate greater than placebo was myalgia (0.3% versus 0% for Repatha® and placebo, respectively).  • Adverse 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. References: 1. Repatha® (evolocumab) Prescribing Information, Amgen. 2. Data on file, Amgen[6];2016. 3. Data on file, Amgen[7]; 2015. © 2016 Amgen Inc. All rights reserved. Not for reproduction or distribution. USA-145-033459 07-16 The proportions of patients who discontinued treatment due to local injection site reactions in Repatha®-treated and placebo-treated patients were 0.1% and 0%, respectively. Allergic reactions occurred in 5.1% and 4.7% of Repatha®-treated and placebo-treated patients, respectively. The most common allergic 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%). Neurocognitive events were reported in less than or equal to 0.2% in Repatha®-treated and placebo-treated patients. In a pool of placebo- and active-controlled trials, as well as open-label extension studies that followed them, a total of 1,988 patients treated with Repatha® had at least one LDL-C value < 25 mg/dL. Changes to background lipid-altering therapy were not made in response to low LDL-C values, and Repatha® dosing was not modified or interrupted on this basis. Although adverse consequences of very low LDL-C were not identified in these trials, the long-term effects of very low levels of LDL-C induced by Repatha® are unknown. Musculoskeletal adverse reactions were reported in 14.3% of Repatha®-treated patients and 12.8% of placebo-treated patients. The most common adverse reactions that occurred at a rate greater than placebo were back pain (3.2% versus 2.9% for Repatha® and placebo, respectively), arthralgia (2.3% versus 2.2%), and myalgia (2.0% versus 1.8%). • Immunogenicity: Repatha® is a human monoclonal antibody. As with all therapeutic proteins, there is a potential for immunogenicity with Repatha®. Please see Brief Summary of Prescribing Information on adjacent page.