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NOW APPROVED
REPATHA
™
A NEW PCSK9 INHIBITOR FOR INTENSIVE, PREDICTABLE LDL-C REDUCTION
in adults with clinical ASCVD or HeFH on maximally tolerated statin therapy as an adjunct to diet
Indication
• Repatha™ is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor antibody indicated
as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with
heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular
disease, who require additional lowering of LDL cholesterol (LDL-C).
• Limitations of Use: 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, included:
Local injection site reactions that occurred in 3.2% and 3.0% of Repatha™-treated and placebotreated 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 patients and placebo-treated patients were 0.1% and 0%, respectively.
References: 1. Repatha™ (evolocumab) Prescribing Information v2, Amgen. 2. Data on file, Amgen;[1]; 2015.
3. Data on file, Amgen;[2]; 2015.
© 2015 Amgen Inc. All rights reserved.
Not for reproduction. USA-145-109360
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 longterm 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 full Prescribing Information on adjacent page.
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