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® |
Median achieved LDL-C* |
Statin + placebo |
---|---|---|---|
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 |
*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.
EBBINGHAUS studied 1,974 patients from the Repatha® CV Outcomes Trial3
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.
CVD = cardiovascular disease; LDL-C = low-density lipoprotein cholesterol; MI = myocardial infarction.
LDL-C = low-density lipoprotein cholesterol; MI = myocardial infarction.
ACS = acute coronary syndrome; LDL-C = low-density lipoprotein cholesterol; MI = myocardial infarction; PCSK9 = proprotein convertase subtilisin/kexin type 9.
Reference: 1. Repatha® (evolocumab) prescribing information, Amgen.
Contraindication: Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in Repatha®. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha®.
Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, have been reported in patients treated with Repatha®. If signs or symptoms of serious hypersensitivity 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: The most common adverse reactions (>5% of patients treated with Repatha® and 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. Hypersensitivity reactions occurred in 5.1% and 4.7% of Repatha®-treated and placebo-treated patients, respectively. The most common hypersensitivity 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 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 treated with Repatha® compared with 7.7% in patients that received 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.
IMPORTANT SAFETY INFORMATION
Contraindication: Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in Repatha®. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha®.
Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, have been reported in patients treated with Repatha®. If signs or symptoms of serious hypersensitivity 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: The most common adverse reactions (>5% of patients treated with Repatha® and 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. Hypersensitivity reactions occurred in 5.1% and 4.7% of Repatha®-treated and placebo-treated patients, respectively. The most common hypersensitivity 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 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 treated with Repatha® compared with 7.7% in patients that received 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.