INDICATIONS

Repatha® is indicated:

  • To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events... READ MORE

For US healthcare professionals

REPATHA® IS A FULLY HUMAN MONOCLONAL ANTIBODY THAT INHIBITS PCSK9 TO LOWER LDL-C1

PCSK9

PCSK9-Repatha® Complex

Selectively Targets PCSK9

  • Maximum suppression of free PCSK9 within 4 hours
  • The mean half-life is 11 to 17 days

PCSK9-Repatha® Complex

Add Repatha® to Reduce LDL-C

ADD REPATHA®

Normally, PCSK9 binds to the LDL receptor (LDLR) on the surface of hepatocytes, leading to the degradation of the LDLR and higher LDL-C levels.

Repatha® enhances removal of LDL-cholesterol by inhibiting PCSK9, increasing the number of LDL receptors on the surface of the liver, resulting in reduction of LDL-C from circulation.

Watch the Mechanism of Action (MOA) of Repatha®

Repatha® Mechanism of Action

Duration: 0:18 Minutes

Repatha® (evolocumab) lowers LDL-C levels by inhibiting PCSK9, increasing the number of LDLRs on the hepatocyte surface, thereby resulting in lower LDL-C concentrations.

LDL-C, low–density lipoprotein cholesterol; LDLR, low density lipoprotein receptor; PCSK9, proprotein convertase subtilisin/kexin type 9.

References: 1. Repatha® (evolocumab) prescribing information, Amgen.

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 Hypercholesterolemia: 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®.

Indications

Repatha® is indicated:

  • To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events.
  • As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia and in adults with heterozygous familial hypercholesterolemia (HeFH)

Please see full Prescribing Information.

Important Safety Information

Back To Top