CardioSource WorldNews - Page 40
For adults with clinical ASCVD on maximally tolerated statin therapy as an adjunct to diet1
THE FIRST AND ONLY PCSK9 INHIBITOR WITH A SINGLE MONTHLY INJECTION
Two dosing options designed with your patients in mind
ONCE A MONTH
EVERY 2 WEEKS
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
• 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;2016. 3. Data on file, Amgen; 2015.
© 2016 Amgen Inc. All rights reserved.
Not for reproduction or distribution.
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
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.