For adults with clinical ASCVD on maximally tolerated statin therapy as an adjunct to diet 1
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 single-use , on-body infusor with prefi lled cartridge
Hidden 29-gauge needle 2
Repatha ® SureClick ® single-use , prefi lled autoinjector
Hidden 27-gauge needle 3
Steady delivery of the 420 mg / 3.5 mL dose subcutaneously over 9 minutes 2
Delivers the 140 mg / mL dose subcutaneously up to 15 seconds 1
Securely adheres to the body so patients can be hands free during administration while they perform moderate activities 2
After one push of a button , the on-body device does the work
Consider for patients who are comfortable self-injecting with a hand-held device
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 , infl uenza , 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 .
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 modifi ed or interrupted on this basis . Although adverse consequences of very low LDL-C were not identifi ed 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 .
References : 1 . Repatha ® ( evolocumab ) Prescribing Information , Amgen . 2 . Data on fi le , Amgen [ 6 ]; 2016 . 3 . Data on fi le , Amgen [ 7 ]; 2015 .
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