1 140 mg/ml dose every 2 weeks

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

THE FIRST AND ONLY PCSK9 INHIBITOR WITH:


SINGLE MONTHLY INJECTION

and every 2 week injection

NO TITRATION

needed with either dosing schedule1

30-DAY STORAGE

at room temperature for patients1


Repatha® offers similar LDL-C reductions with both dosing schedules

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

1 140 mg/ml dose every 2 weeks

Devices designed with your patients in mind

ONCE MONTHLY

Single-use on-body infusor with
prefilled cartridge

device

Repatha® PushtronexTM System

Hidden 29-gauge needle3

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

EVERY 2 WEEKS

Single-use,
prefilled autoinjector

dosing single click

Repatha® SureClick®

Hidden 27-gauge needle

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

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

Maximize efficacy from the start

In patients with clinical ASCVD,

  • Repatha® offers similar LDL-C reductions with both delivery schedules
    • Repatha® 140 mg Q2W + a statin reduced mean LDL-C up to 77% (range 63% to 77%; mean 71%) compared to placebo + a statin1,2
    • Repatha® 420 mg QM + 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 in patients with clinical ASCVD. Maximum-dose statins used in Study 1 were atorvastatin 80 mg, rosuvastatin 40 mg, and simvastatin 40 mg.1,*

Q2W = every 2 weeks; QM = once monthly.

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 delivered1
  • 95% of patients successfully inject at home with either device3,*
    • 95% of patients in the PushtronexTM group (n = 82), and 94% of patients in the SureClick® autoinjector group (n = 82)
  • Call 1-844-REPATHA (844-737-2842) or visit RepathaInjection.com

*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.

References:

  1. Repatha® (evolocumab) Prescribing Information, Amgen.
  2. Data on file, Amgen[1]; 2015.
  3. Dent R, Joshi R, Djedjos CS, et al. SpringerPlus. 2016;5:300:1-8.
IMPORTANT SAFETY INFORMATION
+
See MoreClose

IMPORTANT SAFETY INFORMATION

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.

Close