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Physician NPI #: ________________________________
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.
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.
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,
and nasopharyngitis.
Immunogenicity: Repatha
®
is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity
with Repatha
®
.
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