INDICATIONS

Repatha® is indicated:

  • To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring ... 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

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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 FOURIER 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

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