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INDICATIONS AND IMPORTANT SAFETY INFORMATION
Prevention of Cardiovascular Events: In adults with established cardiovascular disease, Repatha
is indicated to reduce the risk
of myocardial infarction, stroke, and coronary revascularization.
Primary Hyperlipidemia (including Heterozygous Familial Hypercholesterolemia): Repatha
is indicated as an adjunct to diet,
alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary
hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C).
Homozygous Familial Hypercholesterolemia: Repatha
is indicated as an adjunct to diet and other LDL-lowering therapies
(e.g., statins, ezetimibe, LDL apheresis) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH) who
require additional lowering of LDL-C.
The safety and effectiveness of Repatha
have not been established in pediatric patients with HoFH who are younger than
13 years old or in pediatric patients with primary hyperlipidemia or HeFH.
is contraindicated in patients with a history of a serious hypersensitivity reaction to Repatha
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
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
and occurring more frequently than placebo) were: diabetes mellitus (8.8% Repatha
, 8.2% placebo), nasopharyngitis
, 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.
Adverse Reactions in Homozygous Familial Hypercholesterolemia (HoFH): The adverse reactions that occurred in at least two
patients treated with Repatha
and more frequently than placebo were: upper respiratory tract infection, influenza, gastroenteritis,
is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity
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