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If you are a patient who wants to learn more about VASCEPA, click vascepa.com

Important Safety Information

Full Prescribing Information

For US Healthcare Professionals Only

About Amarin

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CV
Outcomes
The VASCEPA PatientCV Outcomes DataTotal Events AnalysisCoronary
Revascularization AnalysisSafety & Side Effects
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VASCEPA?
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FOR ADULTS ON MAXIMALLY TOLERATED STATINS WITH TG ≥150 MG/DL AND ESTABLISHED CVD
OR DIABETES AND ≥2 CVD RISK FACTORS


UNPRECEDENTED CV RISK REDUCTION ON TOP OF A STATIN1

 * Remaining Risk
 * Patient with Established CVD
 * Patient with T2D and ≥2 Risk Factors
 * Patient with Established CVD and T2D

Myth: Reduction in LDL-C eliminates Persistent CV Risk (P-CVR).

Fact: Dr. Payal Kohli, an expert in preventive cardiology, says P-CVR remains
despite LDL-C control.2-4


WATCH DR. KOHLI REVIEW THE LDL-C FACTS AND MYTHS BELOW

Learn more about the Important Safety InformationWatch now
See the groundbreaking results from the VASCEPA CV Outcomes Trial
(REDUCE-IT®)View now

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Approximately every 37-40 seconds, someone will experience an MI or Stroke, or
die from CVD in the United States. And the prevalence of heart disease in both
men and women is only expected to grow.5,6 But, who is at risk?

According to a 2008 trial, patients with TG levels ≥150 mg/dL have a 41% higher
risk of suffering from coronary events* than those with TG <150, despite
achieving LDL-C <70 mg/dL.7 This indicates that elevated TG, similar to high
LDL-C, is a critical risk factor for P-CVR. However, TG-lowering agents have
failed to show CV risk reduction, proving that more strategies to reduce P-CVR
are needed.8-12


MEET THE PATIENT TYPES WHO MAY BENEFIT FROM VASCEPA

Not an actual VASCEPA patient.

David, 65

 * Established CVD (CAD & history of MI)
 * On statin therapy
 * TG: 185 mg/dL

Additional info on David

Reason for visit: Routine office visit

Clinical CVD diagnosis:

 * MI & stents placed at 57 yrs. old
 * CAD & hypertension
 * History of high cholesterol

Family history:

 * CVD, father died from MI at 68 yrs. old

Diagnostics:

 * LDL-C: 68 mg/dL
 * TG: 185 mg/dL
 * HDL-C: 42 mg/dL
 * BP: 138/82 mm Hg
 * BMI: 34

Medications:

Atorvastatin 80 mg, irbesartan, clopidogrel, ASA, and metoprolol


VASCEPA CAN HELP PATIENTS LIKE DAVID

See how

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Not an actual VASCEPA patient.

Donna, 55

 * T2D, hypertension, and high cholesterol
 * On statin therapy
 * TG: 150 mg/dL

Additional info on Donna

Reason for visit: Younger friend had a CV event; wants to check on her health

Clinical CVD diagnosis:

 * T2D at 42 yrs. old
 * Hypertension
 * High cholesterol

Family history:

 * Mother had CVD; father had hypertension

Diagnostics:

 * LDL-C: 84 mg/dL
 * TG: 150 mg/dL
 * HDL-C: 58 mg/dL
 * BP: 142/82 mm Hg
 * BMI: 31
 * HbA1c: 7.9

Medications:

Rosuvastatin 10 mg, metformin, lisinopril, amlodipine, and pantoprazole


VASCEPA CAN HELP PATIENTS LIKE DONNA

See how

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Not an actual VASCEPA patient.

James, 46

 * Established CVD and T2D
 * On statin therapy
 * TG: 320 mg/dL

Additional info on James

Reason for visit: Approaching the age that his father had an MI

Clinical CVD diagnosis:

 * T2D at age 32 yrs. old
 * High cholesterol
 * PAD
 * Smoker

Family history:

 * Extensive family history of CV disease

Diagnostics:

 * LDL-C: 95 mg/dL
 * TG: 320 mg/dL
 * HDL-C: 40 mg/dL
 * BP: 135/84 mm Hg
 * BMI: 30
 * HbA1c: 8.3

Medications:

Rosuvastatin 10 mg, clopidogrel, ASA, metoprolol, insulin, and sitagliptin and
metformin HCl


VASCEPA CAN HELP PATIENTS LIKE JAMES

See how


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Policy page.





IMPORTANT SAFETY INFORMATION

• VASCEPA is contraindicated in patients with known hypersensitivity (e.g.,
anaphylactic reaction) to VASCEPA or any of its components

• VASCEPA was associated with an increased risk (3% vs 2%) of atrial
fibrillation or atrial flutter requiring hospitalization in a double-blind,
placebo-controlled trial. The incidence of atrial fibrillation was greater in
patients with a previous history of atrial fibrillation or atrial flutter

• It is not known whether patients with allergies to fish and/or shellfish are
at an increased risk of an allergic reaction to VASCEPA. Patients with such
allergies should discontinue VASCEPA if any reactions occur


INDICATIONS AND LIMITATIONS OF USE

• VASCEPA® (icosapent ethyl) is indicated as an adjunct to maximally tolerated
statin therapy to reduce the risk of myocardial infarction, stroke, coronary
revascularization and unstable angina requiring hospitalization in adult
patients with elevated triglyceride (TG) levels (≥150 mg/dL) and established
cardiovascular disease or diabetes mellitus and 2 or more additional risk
factors for cardiovascular disease

• VASCEPA is indicated as an adjunct to diet to reduce TG levels in adult
patients with severe (≥500 mg/dL) hypertriglyceridemia

The effect of VASCEPA on the risk for pancreatitis in patients with severe
hypertriglyceridemia has not been determined.

• VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a
double-blind, placebo-controlled trial. The incidence of bleeding was greater in
patients receiving concomitant antithrombotic medications, such as aspirin,
clopidogrel or warfarin

• Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3%
and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral
edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%) and atrial
fibrillation (5% vs 4%)

• Common adverse reactions in the hypertriglyceridemia trials (incidence ≥1%
more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs
0.3%)

• Adverse Events, Product Complaints, or Special Situations may be reported by
contacting AmarinConnect at 1-855-VASCEPA, emailing
AmarinConnect@Amarincorp.com, or calling the FDA at 1-800-FDA-1088

• Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet
agents should be monitored for bleeding

Please see full Prescribing Information for more information on VASCEPA.

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CAD=coronary artery disease; eCVD=established cardiovascular disease;
MI=myocardial infarction; PAD=peripheral arterial disease; T2D=type 2 diabetes.
*Death, MI, or recurrent acute coronary syndrome.

References: 1. VASCEPA [package insert]. Bridgewater, NJ: Amarin Pharma, Inc.;
2019. 2. Sabatine MS, Giugliano RP, Keech AC, et al. Evolocumab and clinical
outcomes in patients with cardiovascular disease. N Engl J Med.
2017;376(18):1713-1722. 3. Bhatt DL, Steg PG, Miller M, et al; for the REDUCE-IT
Investigators. Cardiovascular risk reduction with icosapent ethyl for
hypertriglyceridemia. N Engl J Med. 2019;380(1):11-22. 4. Cannon CP, Blazing MA,
Giugliano RP, et al. Ezetimibe added to statin therapy after acute coronary
syndromes. N Engl J Med. 2015;372(25):2387-2397. 5. Virani SS, Alonso A,
Benjamin EJ, et al. Heart Disease and Stroke Statistics—2020 Update: A Report
From the American Heart Association. Circulation. 2020;141(9):e139-e596. 6.
American Heart Association. Cardiovascular disease: a costly burden for America.
Projections through 2035.
https://healthmetrics.heart.org/wp-content/uploads/2017/10/Cardiovascular-Disease-A-Costly-Burden.pdf.
Accessed October 22, 2020. 7. Miller M, Cannon CP, Murphy SA, Qin J, Ray KK,
Braunwald E; for the PROVE IT-TIMI 22 Investigators. Impact of triglyceride
levels beyond low-density lipoprotein cholesterol after acute coronary syndrome
in the PROVE IT-TIMI 22 trial. J Am Coll Cardiol. 2008;51(7):724-730. 8. ORIGIN
Trial Investigators; Bosch J, Gerstein HC, Dagenais GR, et al. n–3 fatty acids
and cardiovascular outcomes in patients with dysglycemia. N Engl J Med.
2012;367(4):309-318. 9. Risk and Prevention Study Collaborative Group. n–3 fatty
acids in patients with multiple cardiovascular risk factors. N Engl J Med.
2013;368(19):1800-1808. 10. Rauch B, Schiele R, Schneider S, et al; for the
OMEGA Study Group. OMEGA, a randomized, placebo-controlled trial to test the
effect of highly purified omega-3 fatty acids on top of modern
guideline-adjusted therapy after myocardial infarction. Circulation.
2010;122(21):2152-2159. 11. ASCEND Study Collaborative Group; Bowman L, Mafham
M, Wallendszus K, et al. Effects of n−3 Fatty Acid Supplements in Diabetes
Mellitus. N Engl J Med. 2018;379(16):1540-1550. 12. Manson JE, Cook NR, Lee IM,
et al. Marine n−3 Fatty Acids and Prevention of Cardiovascular Disease and
Cancer. N Engl J Med. 2019;380(1):23-32.

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About Amarin

The wholesale price of VASCEPA is $344.22 for 120 1g capsules and $402.73 for
240 0.5g capsules. Commercially insured patients can save with the VASCEPA
Savings Card. VASCEPA Savings Card may not be used to obtain prescription drugs
paid in part by some Federal or State Programs, or where prohibited by law;
click here for more information. Generic icosapent ethyl capsules available from
Hikma Pharmaceuticals do not have an approved indication for cardiovascular risk
reduction. Amarin retains exclusivity for cardiovascular risk reduction and the
Hikma generic should not be dispensed for this indication.


VASCEPA, Amarin, REDUCE-IT, and Vascepa/Amarin logos are registered trademarks
of the Amarin group of companies.

All other trademarks are the property of their respective companies.

© 2021 Amarin Pharma, Inc. Bridgewater, NJ 08807  All rights
reserved.  US-VAS-03038v5  06/21



This website, Vascepa.com, Vascepasavings.com, Truetoyourheart.com, and the
corporation's website, amarincorp.com, are the only company-sanctioned websites
pertaining to the Amarin group of companies or its product, Vascepa® (icosapent
ethyl) capsules. The Amarin group of companies is not responsible for false or
misleading materials contained on other non–Amarin-controlled websites or other
social media sites.