Only Repatha® Offers the Choice Of a Single Monthly Injection Or One Injection Every 2 Weeks, No Titration Required1

THE FIRST AND ONLY PCSK9 INHIBITOR WITH:

Repatha® single monthly injection Repatha® single monthly injection

Repatha® offers 30-day storage at room temperature for patients1,*

*Room temperature (68°F to 77°F) in the original carton.

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 minutes1-3

Securely adheres to the body so patients
can be hands free during administration
while they perform moderate activities1,2

After one push of a button, the
on-body device does the work1

Download and review the Instructions for Use here

Every 2 weeks

Single-use,
prefilled autoinjector

Repatha® SureClick®

Repatha® SureClick®

Hidden 27-gauge needle4

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

When monitoring LDL-C for patients receiving Repatha® once monthly, note that LDL-C can vary considerably during the dosing interval in some patients.

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 device6,*

    • 95% of patients in the Pushtronex® group (n = 82), and 94% of patients in the SureClick® Autoinjector group (n = 82)6

*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

Both Dosing Options Offer Similar LDL-C Reductions Over the Dosing Interval

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 statin1,6

  • Repatha® 420 mg once monthly + a statin reduced mean LDL-C up to 67% (range 55% to 67%; mean 63%) compared to placebo + a statin1,6

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 studies7

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 statin1,6

  • Repatha® 420 mg once monthly + a statin reduced mean LDL-C up to 67% (range 55% to 67%; mean 63%) compared to placebo + a statin1,6

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 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; 2016. 4. Data on file, Amgen; 2015. 5. Dent R, Joshi R, Djedjos SC, et al. SpringerPlus. 2016;5:300:1-8. 6. Data on file, Amgen; 2015. 7. 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 in Primary Hyperlipidemia, including HeFH: The most common adverse reactions (> 5% of Repatha®-treated patients and occurring more frequently than placebo) in clinical trials in primary hyperlipidemia (including HeFH) 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).

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%).

Adverse reactions in the Cardiovascular Outcomes trial: The safety profile of Repatha® in this trial was generally consistent with the safety profile described above in the 12- and 52-week controlled trials involving patients with primary hyperlipidemia (including HeFH). Serious adverse events occurred in 24.8% and 24.7% of Repatha®-treated and placebo-treated patients, respectively. Adverse events led to discontinuation of study treatment in 4.4% of patients assigned to Repatha® and 4.2% assigned to placebo. Common adverse reactions (>5% of patients treated with Repatha® and occurring more frequently than placebo) included 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.

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

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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Using the SureClick® Autoinjector

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