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REPATHA® SAFETY PROFILE

Across more than 26,000 patients, Repatha® demonstrated a consistent safety profile1

The Repatha® CV Outcomes Study demonstrated the long-term safety of Repatha® added to a statin over a median 2.2 years.2

Repatha® CV Outcomes Study: Adverse Events2-4


Statin + Repatha®
n=13,784
26 mg/dL

Median achieved LDL-C*

Statin + placebo
n=13,780
89 mg/dL

Number of patients

n=13,769

n=13,756

Adverse events (% of patients)



Diabetes

8.8

8.2

Adjudicated case of new-onset diabetes

8.1

7.7

Nasopharyngitis

7.8

7.4

Upper respiratory tract infection

5.1

4.8

Muscle-related event

5.0

4.8

Allergic reaction

3.1

2.9

Injection-site reaction

2.1

1.6

Cataract

1.7

1.8

Neurocognitive event

1.6

1.5

Rhabdomyolysis

0.1

0.1

Laboratory results (% of patients)

Aminotransferase level >3 times the upper limit of the normal range

1.8

1.8

Creatine kinase level >5 times the upper limit of the normal range

0.7

0.7

  • Hemorrhagic stroke: 0.21% statin + Repatha® (n=13,784), 0.18% statin + placebo (n=13,780)

*Median LDL-C achieved at 48 weeks.

The total numbers of patients were 8,337 in the Repatha® group and 8,339 in the placebo + statin group because patients with prevalent diabetes at the start of the trial were excluded.


Repatha® demonstrated long-term safety over a 5-year treatment period5


  • AE rates remained consistent over the treatment course5
  • Discontinuation rate due to AEs: 1.4%/year5
  • Reported AE rates from open-label extension of primary hyperlipidemia trials through 5 years were generally consistent with AE rates from FOURIER and other phase 3 trials3,5

Lowering LDL-C with Repatha® did not impair cognitive function3


EBBINGHAUS studied 1,974 patients from the Repatha® CV Outcomes Trial3


  • Patients were assessed using neuropsychological function tests over a median follow-up of 19 months3
  • Study concluded noninferiority in select cognitive function domains was observed between Repatha® and placebo when added to statin3

References: 1. Data on file, Amgen; 2017. 2. Sabatine MS, Giugliano RP, Keech AC, et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713-1722. 3. Repatha® (evolocumab) prescribing information, Amgen. 4. Data on file, Amgen; 2017. 5. Koren MJ, Sabatine MS, Giugliano RP, et al. Long-term efficacy and safety of evolocumab in patients with hypercholesterolemia. J Am Coll Cardiol. 2019;74:2132-2146.

Important Safety Information

Contraindication: Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to Repatha®. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha®.

Allergic Reactions: Hypersensitivity reactions (e.g. angioedema, 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 in Primary Hyperlipidemia (including HeFH): The most common adverse reactions (>5% of patients treated with Repatha® and occurring 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.

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%).

Adverse Reactions in the Cardiovascular Outcomes Trial: The most common adverse reactions (>5% of patients treated with Repatha® and occurring 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 assigned to Repatha® compared with 7.7% in those assigned to placebo.

Immunogenicity: Repatha® is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity with Repatha®.

Please see full Prescribing Information.