WHO IS REPATHA®FOR?

Repatha® is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (CVD), who require additional lowering of low density lipoprotein cholesterol.1

Although not intended to be a diagnostic tool, these three questions can help you identify Repatha®-appropriate patients.

Does your patient have a history of clinical ASCVD?2,*

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Patients with clinical ASCVD may have had one or more of the following, as defined by the 2013 ACC/AHA Guidelines:

Stroke
Transient ischemic attack
Myocardial infarction
Stable angina
Unstable angina
Coronary or other arterial revascularization
Acute coronary syndromes
Peripheral artery disease

As an adjunct to diet, is your
patient on max tolerated statin therapy?

Maximally tolerated statin therapy includes patients who:

  • Are on the maximum dose of a statin
  • Are on less than the maximum dose of a statin due to tolerability
  • Cannot tolerate any statin type or dose

Repatha® is also appropriate for patients with heterozygous familial hypercholesterolemia (HeFH)3 who are on a maximally tolerated statin as an adjunct to diet and require additional LDL-C lowering.

HeFH is an inherited condition that causes high levels of LDL-C and can be diagnosed using the Simon Broome diagnostic criteria.

The effect of Repatha® on cardiovascular morbidity and mortality has not been determined.1

*Per the 2013 ACC/AHA Guidelines, clinical ASCVD includes history of myocardial infarction (MI), stable or unstable angina (UA), peripheral artery disease (PAD), stroke or transient ischemic attack (TIA), coronary or other arterial revascularization, and acute coronary syndromes.2

In adults, the Simon Broome criteria include an LDL-C of > 190 mg/dL (without therapy) plus clinical criteria (including patient or family history of tendon xanthomas, plus either family history of early CAD or family history of total cholesterol > 290 mg/dL).4



ASCVD = atherosclerotic cardiovascular disease.

Example Repatha® Patient Profiles

Which of your patients could benefit from additional LDL-C lowering with Repatha®?

PATIENT 1

Gender: MaleFemaleMaleAge: 555963

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CLINICAL ASVCD HISTORY
Hospitalized with MI 4 months ago 1 year ago, patient complained of pain in legs and was diagnosed with PAD Patient suffered ischemic stroke 6 months ago
SECONDARY FACTORS
Smoker Diagnosed with diabetes 8 years ago Diagnosed with hypertension 5 years ago
CURRENT LIPID-
LOWERING
THERAPY
Atorvastatin 10 mg Unable to tolerate higher dose of statins due to side effects Ezetimibe 10 mg
Unable to tolerate any dose of statins due to side effects
Atorvastatin 80 mg
On maximum-dose statin
LDL-C LEVEL
126 mg/dL 138 mg/dL 108 mg/dL

References:

  1. Repatha® (evolocumab) Prescribing Information, Amgen.
  2. Stone NJ, Robinson JG, Lichtenstein AH, et al. Circulation. 2014;129:S1-S45.
  3. Raal FJ, Stein SA, Dufour R, et al. Lancet. 2015;385:331-340.
  4. Scientific Steering Committee on behalf of the Simon Broome Register Group. Br Med J. 1991;303:893-896.
IMPORTANT SAFETY INFORMATION
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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.

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