For adults with clinical ASCVD or HeFH on maximally tolerated statin therapy

The first and only pcsk9 inhibitor with:

Repatha® single monthly injection Repatha® single monthly injection

Two dosing options designed with your patients in mind

once a month

Single-use on-body infusor
with prefilled cartridge

Repatha® Pushtronex® system

Repatha® Pushtronex® system

Hidden 29-gauge needle2

Steady delivery of the 420 mg/3.5 mL
dose subcutaneously up to 9 minutes3

Securely adheres to the body so patients
can be hands free during administration
while they perform moderate activities3

After one push of a button, the
on-body device does the work

Download and review the Instructions for Use here

every 2 weeks

Single-use,
prefilled autoinjector

Repatha® SureClick®

Repatha® SureClick®

Hidden 27-gauge needle3

Delivers the 140 mg/mL dose
subcutaneously up to 15 seconds1

Consider for patients who are
comfortable self-injecting with
a hand-held device

Download and review the Instructions for Use here

With either delivery option, feel confident your patients can administer Repatha®

  • Built-in audible and visual cues to signal when the full dose has been delivered2

  • 95% of patients successfully administered at home with either device4,*

    • 95% of patients in the Pushtronex™ group (n = 82), and 94% of patients in the SureClick® autoinjector group (n = 82)

*Patients who reported two full-dose administrations of Repatha® at weeks 4 and 8. Patients received HCP training on how to self-administer.

Patients used three autoinjectors.

Prior to use, wait at least 30 minutes for the SureClick® autoinjector and 45 minutes for the Pushtronex® system to naturally reach room temperature in the carton.1

Do not try to warm the prefilled cartridge by using a heat source, such as hot water or a microwave. If the prefilled cartridge has been warmed with a heat source, use a new on-body infusor and prefilled cartridge and call 1-844-REPATHA (844-737-2842) or visit www.REPATHA.com

Similar LDL-C reductions with both dosing schedules

RESULTS FROM PHASE 3 STUDY

In patients with clinical ASCVD,

  • Repatha® 140 mg every 2 weeks + a statin reduced mean LDL-C up to 77% (range 63% to 77%; mean 71% compared to placebo + a statin1,2

  • Repatha® 420 mg once monthly + a statin reduced mean LDL-C up to 67% (range 55% to 67%; mean 63% compared to placebo + a statin1,2

Results from a 12-week study. Maximum-dose statins used in Study 1 were atorvastatin 80 mg, rosuvastatin 40 mg, and simvastatin 40 mg.1

RESULTS FROM PHASE 2 DOSE-RANGING STUDIES5

Results from phase 2 dose-ranging studies

Results from a pharmacokinetic and pharmacodynamic (PK/PD) substudy of two dose-ranging phase 2 studies.
Patients (n = 132) underwent week 9 and 11 assessments in addition to the every 2 week lipid measurements at weeks 8 and 10.

References:

  1. Repatha® (evolocumab) Prescribing Information, Amgen.

  2. Data on file, Amgen; 2016.

  3. Data on file, Amgen; 2015.

  4. Dent R, Joshi R, Djedjos CS, et al. SpringerPlus. 2016;5:300:1-8.

  5. Koren MJ, Doshi S, Castro R, et al. Poster presented at: American Heart Association Scientific Sessions. November 7-11, 2015; Orlando, FL. Poster M2060.

IMPORTANT SAFETY INFORMATION

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Contraindication: Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to Repatha®.

Allergic reactions: Hypersensitivity reactions (e.g. 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: The most common adverse reactions (> 5% of Repatha®-treated patients and more common than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.

In a 52-week trial, adverse reactions led to discontinuation of treatment in 2.2% of Repatha®-treated patients and 1% of placebo-treated patients. The most common adverse reaction that led to Repatha® treatment discontinuation and occurred at a rate greater than placebo was myalgia (0.3% versus 0% for Repatha® and placebo, respectively).

Adverse 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. The proportions of patients who discontinued treatment due to local injection site reactions in Repatha®-treated patients and placebo-treated patients were 0.1% and 0%, respectively.

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%).

Neurocognitive events were reported in less than or equal to 0.2% in Repatha®-treated and placebo-treated patients.

In a pool of placebo- and active-controlled trials, as well as open-label extension studies that followed them, a total of 1,988 patients treated with Repatha® had at least one LDL‑C value < 25 mg/dL. Changes to background lipid-altering therapy were not made in response to low LDL-C values, and Repatha® dosing was not modified or interrupted on this basis. Although adverse consequences of very low LDL-C were not identified in these trials, the long-term effects of very low levels of LDL-C induced by Repatha® are unknown.

Musculoskeletal adverse reactions were reported in 14.3% of Repatha®-treated patients and 12.8% of placebo-treated patients. The most common adverse reactions that occurred at a rate greater than placebo were back pain (3.2% versus 2.9% for Repatha® and placebo, respectively), arthralgia (2.3% versus 2.2%), and myalgia (2.0% versus 1.8%).

Immunogenicity: Repatha® is a human monoclonal antibody. As with all therapeutic proteins, there is a potential for immunogenicity with Repatha®.

INDICATION
Repatha® is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (CVD), who require additional lowering of low density lipoprotein cholesterol (LDL-C).

The effect of Repatha® on cardiovascular morbidity and mortality has not been determined.

Please see full Prescribing Information.

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What is PCSK9?

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Why Repatha® inhibits PCSK9

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How Repatha® lowers LDL-C levels

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Using the Pushtronex® system

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Use the SureClick® autoinjector

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