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`Exhibit E
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`HIGHLIGHTS OF PRESCRIBING INFORMATION
`
`VASCEPA™ (icosapent ethyl) Capsules, for oral use
`Initial U.S. Approval: 2012
`
`These highlights do not include all of the information needed to use
`VASCEPA™ safely and effectively. See full prescribing information for
`VASCEPA.
`--------------------------INDICATIONS AND USAGE------------------------------
`VASCEPA is an ethyl ester of eicosapentaenoic acid (EPA) indicated as an
`adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe
`(≥ 500 mg/dL) hypertriglyceridemia. (1)
`
`Limitations of Use:
`•The effect of VASCEPA on the risk for pancreatitis in patients with severe
`hypertriglyceridemia has not been determined. (1)
`
`•The effect of VASCEPA on cardiovascular mortality and morbidity in
`patients with severe hypertriglyceridemia has not been determined. (1)
`
`-----------------------DOSAGE AND ADMINISTRATION------------------------
`The daily dose of VASCEPA is 4 grams per day taken as 2 capsules twice
`daily with food. (2)
`Patients should be advised to swallow VASCEPA capsules whole. Do not
`break open, crush, dissolve, or chew VASCEPA. (2)
`
`---------------------DOSAGE FORMS AND STRENGTHS----------------------
`Capsules: 1 gram (3)
`---------------------------------CONTRAINDICATIONS-----------------------------
`VASCEPA is contraindicated in patients with known hypersensitivity (e.g.,
`anaphylactic reaction) to VASCEPA or any of its components. (4)
`
`
`------------------------WARNINGS and PRECAUTIONS-------------------------
`In patients with hepatic impairment, monitor ALT and AST levels
`periodically during therapy. (5.1)
`
`Use with caution in patients with known hypersensitivity to fish and/or
`shellfish. (5.2)
`
`-------------------------------ADVERSE REACTIONS------------------------------
`The most common reported adverse reaction (incidence >2% and greater than
`placebo) was arthralgia. (6)
`
`To report SUSPECTED ADVERSE REACTIONS, contact Amarin
`Pharma Inc. at 1-855-VASCEPA (1-855-827-2372) or contact the FDA at
`1-800-FDA-1088 or www.fda.gov/medwatch.
`
`------------------------------DRUG INTERACTIONS--------------------------------
`Omega-3 acids may prolong bleeding time. Patients receiving treatment with
`VASCEPA and other drugs affecting coagulation (e.g., anti-platelet agents)
`should be monitored periodically. (7)
`
`-------------------------USE IN SPECIFIC POPULATIONS----------------------
`Pregnancy: Use during pregnancy only if the potential benefit justifies the
`potential risk to the fetus. (8.1)
`
`Pediatric Use: The safety and effectiveness in pediatric patients have not been
`established. (8.4)
`
`See 17 for PATIENT COUNSELING INFORMATION and FDA-
`approved patient labeling.
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`Revised: 07/2012
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`____________________________________________________________________________________________________________________
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`FULL PRESCRIBING INFORMATION:
`
`CONTENTS*
`1
`INDICATIONS AND USAGE
`2 DOSAGE AND ADMINISTRATION
`3 DOSAGE FORMS AND STRENGTHS
`4 CONTRAINDICATIONS
`5 WARNINGS AND PRECAUTIONS
`5.1 Monitoring: Laboratory Tests
`5.2 Fish Allergy
`6 ADVERSE REACTIONS
`6.1 Clinical Trials Experience
`7 DRUG INTERACTIONS
`7.1 Anticoagulants
`8 USE IN SPECIFIC POPULATIONS
`8.1 Pregnancy
`8.3 Nursing Mothers
`8.4 Pediatric Use
`8.5 Geriatric Use
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`9 DRUG ABUSE AND DEPENDENCE
`11 DESCRIPTION
`12 CLINICAL PHARMACOLOGY
`12.3 Mechanism of Action
`12.4 Pharmacokinetics
`13 NONCLINICAL TOXICOLOGY
`13.1 Carcinogenesis, Mutagenesis, Impairment of
`Fertility
`14 CLINICAL STUDIES
`14.1 Severe Hypertriglyceridemia
`16 HOW SUPPLIED/STORAGE AND HANDLING
`17 PATIENT COUNSELING INFORMATION
`17.1 Information for Patients
`
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`*Sections or subsections omitted from the full prescribing information are not
`listed.
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`FULL PRESCRIBING INFORMATION
`
`1
`
`INDICATIONS AND USAGE
`VASCEPA™ (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride
`(TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
`Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet and
`exercise regimen before receiving VASCEPA and should continue this diet and exercise regimen
`with VASCEPA.
`Attempts should be made to control any medical problems such as diabetes mellitus,
`hypothyroidism, and alcohol intake that may contribute to lipid abnormalities. Medications
`known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be
`discontinued or changed, if possible, prior to consideration of TG-lowering drug therapy.
`
`Limitations of Use:
`The effect of VASCEPA on the risk for pancreatitis in patients with severe
`hypertriglyceridemia has not been determined.
`The effect of VASCEPA on cardiovascular mortality and morbidity in patients with
`severe hypertriglyceridemia has not been determined.
`
`2
`
`DOSAGE AND ADMINISTRATION
`Assess lipid levels before initiating therapy. Identify other causes (e.g., diabetes mellitus,
`hypothyroidism, or medications) of high triglyceride levels and manage as appropriate. [see
`Indications and Usage (1)].
`Patients should engage in appropriate nutritional intake and physical activity before
`receiving VASCEPA, which should continue during treatment with VASCEPA.
`The daily dose of VASCEPA is 4 grams per day taken as 2 capsules twice daily with
`
`food.
`
`Patients should be advised to swallow VASCEPA capsules whole. Do not break open,
`crush, dissolve, or chew VASCEPA.
`
`3
`
`DOSAGE FORMS AND STRENGTHS
`VASCEPA capsules are supplied as 1-gram amber-colored soft-gelatin capsules
`imprinted with VASCEPA.
`
`CONTRAINDICATIONS
`4
`VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic
`
`reaction) to VASCEPA or any of its components.
`
`WARNINGS AND PRECAUTIONS
`5
`5.1 Monitoring: Laboratory Tests
`In patients with hepatic impairment, alanine aminotransferase (ALT) and aspartate
`aminotransferase (AST) levels should be monitored periodically during therapy with VASCEPA.
`
`Fish Allergy
`5.2
`VASCEPA contains ethyl esters of the omega-3 fatty acid, eicosapentaenoic acid (EPA),
`
`obtained from the oil of fish. It is not known whether patients with allergies to fish and/or
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`shellfish are at increased risk of an allergic reaction to VASCEPA. VASCEPA should be used
`with caution in patients with known hypersensitivity to fish and/or shellfish.
`6
`ADVERSE REACTIONS
`6.1 Clinical Trials Experience
`Because clinical trials are conducted under widely varying conditions, adverse reaction
`rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical
`trials of another drug and may not reflect the rates observed in practice.
`Adverse reactions reported in at least 2% and at a greater rate than placebo for patients
`treated with VASCEPA based on pooled data across two clinical studies are listed in Table 1.
`
`Table 1. Adverse Reactions Occurring at Incidence >2% and Greater than Placebo in
`Double-Blind, Placebo-Controlled Trials*
`
`VASCEPA
`Placebo
`(N=622)
`(N=309)
`Adverse Reaction
`n
`%
`n
`%
`14
`2.3
`3
`1.0
`Arthralgia
`*Studies included patients with triglycerides values of 200 to 2000 mg/dL.
`
`An additional adverse reaction from clinical studies was oropharyngeal pain.
`
`DRUG INTERACTIONS
`7
`
`7.1 Anticoagulants
`
`Some published studies with omega-3 fatty acids have demonstrated prolongation of
`bleeding time. The prolongation of bleeding time reported in those studies has not exceeded
`normal limits and did not produce clinically significant bleeding episodes. Patients receiving
`treatment with VASCEPA and other drugs affecting coagulation (e.g., anti-platelet agents)
`should be monitored periodically.
`
`USE IN SPECIFIC POPULATIONS
`8
`8.1 Pregnancy
`Pregnancy Category C: There are no adequate and well-controlled studies in pregnant
`women. It is unknown whether VASCEPA can cause fetal harm when administered to a pregnant
`woman or can affect reproductive capacity. VASCEPA should be used during pregnancy only if
`the potential benefit to the patient justifies the potential risk to the fetus.
`In pregnant rats given oral gavage doses of 0.3, 1 and 2 g/kg/day icosapent ethyl from
`gestation through organogenesis all drug treated groups had visceral or skeletal abnormalities
`including: 13th reduced ribs, additional liver lobes, testes medially displaced and/or not
`descended at human systemic exposures following a maximum oral dose of 4 g/day based on
`body surface comparisons. Variations including incomplete or abnormal ossification of various
`skeletal bones were observed in the 2 g/kg/day group at 5 times human systemic exposure
`following an oral dose of 4 g/day based on body surface area comparison.
`In a multigenerational developmental study in pregnant rats given oral gavage doses of
`0.3, 1, 3 g/kg/day ethyl-EPA from gestation day 7-17, an increased incidence of absent optic
`nerves and unilateral testes atrophy were observed at ≥0.3 g/kg/day at human systemic exposure
`following an oral dose of 4 g/day based on body surface area comparisons across species.
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`Additional variations consisting of early incisor eruption and increased percent cervical ribs were
`observed at the same exposures. Pups from high dose treated dams exhibited decreased
`copulation rates, delayed estrus, decreased implantations and decreased surviving fetuses (F2)
`suggesting multigenerational effects of ethyl-EPA at 7 times human systemic exposure following
`4 g/day dose based on body surface area comparisons across species.
`In pregnant rabbits given oral gavage doses of 0.1, 0.3, and 1 g/kg/day from gestation
`through organogenesis there were increased dead fetuses at 1 g/kg/day secondary to maternal
`toxicity (significantly decreased food consumption and body weight loss).
`In pregnant rats given ethyl-EPA from gestation day 17 through lactation day 20 at 0.3, 1,
`3 g/kg/day complete litter loss was observed in 2/23 litters at the low dose and 1/23 mid-dose
`dams by post-natal day 4 at human exposures based on a maximum dose of 4 g/day comparing
`body surface areas across species.
`
`8.3 Nursing Mothers
`Studies with omega-3-acid ethyl esters have demonstrated excretion in human milk. The
`effect of this excretion is unknown; caution should be exercised when VASCEPA is
`administered to a nursing mother. In lactating rats, given oral gavage 14C-ethyl EPA, drug levels
`were 6 to 14 times higher in milk than in plasma.
`
`8.4 Pediatric Use
`Safety and effectiveness in pediatric patients have not been established.
`
`8.5 Geriatric Use
`Of the total number of subjects in clinical studies of VASCEPA, 33% were 65 years of
`age and over. No overall differences in safety or effectiveness were observed between these
`subjects and younger subjects, and other reported clinical experience has not identified
`differences in responses between the elderly and younger patients, but greater sensitivity of some
`older individuals cannot be ruled out.
`
`9 DRUG ABUSE AND DEPENDENCE
`VASCEPA does not have any known drug abuse or withdrawal effects.
`
`11 DESCRIPTION
`VASCEPA, a lipid-regulating agent, is supplied as a 1-gram amber-colored, liquid-filled
`soft gelatin capsule for oral administration.
`Each VASCEPA capsule contains 1 gram of icosapent ethyl. Icosapent ethyl is an ethyl
`ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent
`ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is
`ethyl all-cis-5,8,11,14,17-icosapentaenoate with the following chemical structure:
`
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`VASCEPA 1 gram capsules also contain the following inactive ingredients: tocopherol,
`gelatin, glycerin, maltitol, sorbitol, and purified water.
`12 CLINICAL PHARMACOLOGY
`12.1 Mechanism of Action
`Studies suggest that EPA reduces hepatic very low-density lipoprotein triglycerides
`(VLDL-TG) synthesis and/or secretion and enhances TG clearance from circulating VLDL
`particles. Potential mechanisms of action include increased β-oxidation; inhibition of
`acyl-CoA:1,2-diacylglycerol acyltransferase (DGAT); decreased lipogenesis in the liver; and
`increased plasma lipoprotein lipase activity.
`
`12.3 Pharmacokinetics
`Absorption: After oral administration, VASCEPA is de-esterified during the absorption
`process and the active metabolite EPA is absorbed in the small intestine and enters the systemic
`circulation mainly via the thoracic duct lymphatic system. Peak plasma concentrations of EPA
`were reached approximately 5 hours following oral doses of VASCEPA.
`VASCEPA was administered with or following a meal in all clinical studies; no food
`effect studies were performed. Take VASCEPA with or following a meal.
`Distribution: The mean volume of distribution at steady-state of EPA is approximately
`88 liters. The majority of EPA circulating in plasma is incorporated in phospholipids,
`triglycerides and cholesteryl esters, and <1% is present as the unesterified fatty acid. Greater than
`99% of unesterified EPA is bound to plasma proteins.
`Metabolism and Excretion: EPA is mainly metabolized by the liver via beta-oxidation
`similar to dietary fatty acids. Beta oxidation splits the long carbon chain of EPA into acetyl
`Coenzyme A, which is converted into energy via the Krebs cycle. Cytochrome P450-mediated
`metabolism is a minor pathway of elimination of EPA. The total plasma clearance of EPA at
`steady state is 684 mL/hr. The plasma elimination half-life (t1/2) of EPA is approximately 89
`hours. VASCEPA does not undergo renal excretion.
`Drug-Drug Interactions
`VASCEPA was studied at the 4 g/day dose level with the following medications which
`are typical substrates of cytochrome P450 enzymes, and no drug-drug interactions were
`observed:
`Omeprazole: In a drug-drug interaction study with 28 healthy adult subjects, VASCEPA
`4 g/day at steady-state did not significantly change the steady-state AUCτ or Cmax of omeprazole
`when co-administered at 40 mg/day to steady-state.
`Rosiglitazone: In a drug-drug interaction study with 28 healthy adult subjects,
`VASCEPA 4 g/day at steady-state did not significantly change the single dose AUC or Cmax of
`rosiglitazone at 4 mg.
`Warfarin: In a drug-drug interaction study with 25 healthy adult subjects, VASCEPA
`4 g/day at steady-state did not significantly change the single dose AUC or Cmax of R- and S-
`warfarin or the anti-coagulation pharmacodynamics of warfarin when co-administered as
`racemic warfarin at 25 mg.
`Atorvastatin: In a drug-drug interaction study of 26 healthy adult subjects, VASCEPA 4
`g/day at steady-state did not significantly change the steady-state AUCτ or Cmax of atorvastatin,
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`2-hydroxyatorvastatin, or 4-hydroxyatorvastatin when co-administered with atorvastatin
`80 mg/day to steady-state.
`Specific Populations
`Gender: When administered VASCEPA in clinical trials, plasma total EPA
`concentrations did not differ significantly between men and women.
`Pediatric: The pharmacokinetics of VASCEPA has not been studied in pediatric patients.
`Hepatic or Renal Impairment: VASCEPA has not been studied in patients with renal or
`hepatic impairment.
`
`13 NONCLINICAL TOXICOLOGY
`13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
`In a 2-year rat carcinogenicity study with oral gavage doses of 0.09, 0.27, and 0.91
`g/kg/day icosapent ethyl, respectively, males did not exhibit drug-related neoplasms.
`Hemangiomas and hemangiosarcomas of the mesenteric lymph node, the site of drug absorption,
`were observed in females at clinically relevant exposures based on body surface area
`comparisons across species relative to the maximum clinical dose of 4 g/day. Overall incidence
`of hemangiomas and hemangiosarcomas in all vascular tissues did not increase with treatment.
`In a 6-month carcinogenicity study in Tg.rasH2 transgenic mice with oral gavage doses
`of 0.5, 1, 2, and 4.6 g/kg/day icosapent ethyl, drug-related incidences of benign squamous cell
`papilloma in the skin and subcutis of the tail was observed in high dose male mice. The
`papillomas were considered to develop secondary to chronic irritation of the proximal tail
`associated with fecal excretion of oil and therefore not clinically relevant. Drug-related
`neoplasms were not observed in female mice.
`Icosapent ethyl was not mutagenic with or without metabolic activation in the bacterial
`mutagenesis (Ames) assay or in the in vivo mouse micronucleus assay. A chromosomal
`aberration assay in Chinese Hamster Ovary (CHO) cells was positive for clastogenicity with and
`without metabolic activation.
`In an oral gavage rat fertility study, ethyl-EPA, administered at doses of 0.3, 1, and
`3 g/kg/day to male rats for 9 weeks before mating and to female rats for 14 days before mating
`through day 7 of gestation, increased anogenital distance in female pups and increased cervical
`ribs were observed at 3 g/kg/day (7 times human systemic exposure with 4 g/day clinical dose
`based on a body surface area comparison).
`
`14 CLINICAL STUDIES
`14.1 Severe Hypertriglyceridemia
`The effects of VASCEPA 4 grams per day were assessed in a randomized, placebo-
`controlled, double-blind, parallel-group study of adult patients (76 on VASCEPA, 75 on
`placebo) with severe hypertriglyceridemia. Patients whose baseline TG levels were between 500
`and 2,000 mg/dL were enrolled in this study for 12 weeks. The median baseline TG and LDL-C
`levels in these patients were 684 mg/dL and 86 mg/dL, respectively. Median baseline HDL-C
`level was 27 mg/dL. The randomized population in this study was mostly Caucasian (88%) and
`male (76%). The mean age was 53 years and the mean body mass index was 31 kg/m2. Twenty-
`five percent of patients were on concomitant statin therapy, 28% were diabetics, and 39% of the
`patients had TG levels >750 mg/dL.
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`The changes in the major lipoprotein lipid parameters for the groups receiving
`VASCEPA or placebo are shown in Table 2.
`
`Table 2. Median Baseline and Percent Change from Baseline in Lipid Parameters in
`Patients with Severe Hypertriglyceridemia (≥500 mg/dL)
`Vascepa 4 g/day
`Placebo
`N=76
`N=75
`Parameter
`Baseline % Change
`Baseline % Change
`680
`-27
`703
`+10
`TG (mg/dL)
`91
`-5
`86
`-3
`LDL-C (mg/dL)
`225
`-8
`229
`+8
`Non-HDL-C (mg/dL)
`254
`-7
`256
`+8
`TC (mg/dL)
`27
`-4
`27
`0
`HDL-C (mg/dL)
`123
`-20
`124
`+14
`VLDL-C (mg/dL)
`121
`-4
`118
`+4
`Apo B (mg/dL)
`% Change= Median Percent Change from Baseline
`Difference= Median of [VASCEPA % Change – Placebo % Change] (Hodges-Lehmann Estimate)
`p-values from Wilcoxon rank-sum test
`*p-value < 0.001 (primary efficacy endpoint)
`**p-value < 0.05 (key secondary efficacy endpoints determined to be statistically significant according to the pre-specified
`multiple comparison procedure)
`
`Difference (95%
`Confidence
`Interval)
` -33* (-47, -22)
`-2 (-13, +8)
`-18 (-25, -11)
`-16 (-22, -11)
`-4 (-9, +2)
` -29** (-43, -14)
`-9**(-14, -3)
`
`VASCEPA 4 grams per day reduced median TG, VLDL-C, and Apo B levels from
`baseline relative to placebo. The reduction in TG observed with VASCEPA was not associated
`with elevations in LDL-C levels relative to placebo.
`The effect of VASCEPA on the risk of pancreatitis in patients with severe
`hypertriglyceridemia has not been determined.
`The effect of VASCEPA on cardiovascular mortality and morbidity in patients with
`severe hypertriglyceridemia levels has not been determined.
`16
`HOW SUPPLIED/STORAGE AND HANDLING
`VASCEPA (icosapent ethyl) capsules are supplied as 1-gram amber-colored soft-gelatin
`capsules imprinted with VASCEPA.
`Bottles of 120: NDC 52937-001-20.
`Store at 20° to 25° C (68° to 77°F); excursions permitted to 15° to 30° C (59° to 86°F)
`[see USP Controlled Room Temperature]. Keep out of reach of children.
`
`17
`17.1
`
`PATIENT COUNSELING INFORMATION
`Information for Patients
`VASCEPA should be used with caution in patients with known sensitivity or
`allergy to fish and/or shellfish [see Warnings and Precautions (5.2)].
`Patients should be advised that use of lipid-regulating agents does not reduce the
`importance of appropriate nutritional intake and physical activity [see Dosage and
`Administration (2)].
`
`Patients should be advised not to alter VASCEPA capsules in any way and to
`ingest intact capsules only [see Dosage and Administration (2)].
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`Instruct patients to take VASCEPA as prescribed. If a dose is missed, patients
`
`should take it as soon as they remember. However if they miss one day of VASCEPA,
`they should not double the dose when they take it.
`
`Distributed by:
`Amarin Pharma Inc.
`Bedminster, NJ, USA
`Manufactured by:
`Banner Pharmacaps
`Tilburg, The Netherlands
`
`Manufactured for:
`Amarin Pharmaceuticals Ireland Limited
`Dublin, Ireland
`+1-855-VASCEPA (+1-855-827-2372)
`www.VASCEPA.com
`
`VASCEPA is a trademark of Amarin Pharmaceuticals Ireland Limited
`©2012 Amarin Pharmaceuticals Ireland Limited
`P00120A
`7/12
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`PATIENT INFORMATION
`VASCEPA™ (pronounced vas-EE-puh)
`(icosapent ethyl)
`Capsules
`
`Read this Patient Information before you start taking VASCEPA and each time you get a refill.
`There may be new information. This information does not take the place of talking with your
`doctor about your medical condition or your treatment.
`What is VASCEPA?
`VASCEPA is a prescription medicine used along with a low-fat and low-cholesterol diet to lower
`high levels of triglycerides (fats) in adults.
`It is not known if VASCEPA changes your risk of having inflammation of your pancreas
`(pancreatitis).
`It is not known if VASCEPA prevents you from having a heart attack or stroke.
`It is not known if VASCEPA is safe and effective in children.
`Who should not take VASCEPA?
`Do not take VASCEPA if you are allergic to icosapent ethyl or any of the ingredients in
`VASCEPA. See the end of this leaflet for a complete list of ingredients in VASCEPA.
`What should I tell my doctor before taking VASCEPA?
`Before you take VASCEPA, tell your doctor if you:
` have diabetes.
` have a low thyroid problem (hypothyroidism).
` have a liver problem.
` have a pancreas problem.
` are allergic to fish or shellfish. It is not known if people who are allergic to fish or shellfish
`are also allergic to VASCEPA.
` are pregnant, or planning to become pregnant. It is not known if VASCEPA will harm your
`unborn baby.
` are breastfeeding or plan to breastfeed. VASCEPA can pass into your milk, and may harm
`your baby. Talk to your doctor about the best way to feed your baby if you take VASCEPA.
`
`Tell your doctor about all the medicines you take, including prescription and non-prescription
`medicines, vitamins, and dietary or herbal supplements.
`VASCEPA can interact with certain other medicines that you are taking.
`Especially tell your doctor if you take medicines that affect your blood clotting (anticoagulants
`or blood thinners).
`Know the medicines you take. Keep a list of them to show your doctor and pharmacist when
`you get a new medicine.
`How should I take VASCEPA?
` Take VASCEPA exactly as your doctor tells you to take it.
` Do not change your dose or stop taking VASCEPA without talking to your doctor.
` You should not take more than 4 capsules of VASCEPA each day. Do not take more
`capsules than what is prescribed by your doctor.
` Take VASCEPA capsules whole. Do not break, crush, dissolve, or chew VASCEPA
`capsules before swallowing.
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`If you miss a dose of VASCEPA, take it as soon as you remember. However, if you miss one
`day of VASCEPA, do not double your dose when you take it.
` Your doctor may start you on a diet that is low in saturated fat, cholesterol, carbohydrates,
`and low in added sugars before giving you VASCEPA. Stay on this diet while taking
`VASCEPA.
` Your doctor may do blood tests to check your triglyceride and other lipid levels while you
`take VASCEPA.
`What are the possible side effects of VASCEPA?
`
`If you have liver problems and are taking VASCEPA, your doctor should do blood tests during
`treatment.
`
`The most common side effect of VASCEPA is joint pain. As with all drugs, you may
`experience a serious side effect when taking VASCEPA. Talk to your doctor if you have a
`side effect that bothers you or does not go away.
`This is not the only side effect of VASCEPA. For more information, ask your doctor or
`pharmacist.
`Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-
`800-FDA-1088.
`How should I store VASCEPA?
` Store VASCEPA at room temperature between 68° to 77° F (20° to 25° C).
` Safely throw away medicine that is out of date or no longer needed.
`Keep VASCEPA and all medicine out of the reach of children.
`General information about the safe and effective use of VASCEPA.
`Medicines are sometimes prescribed for purposes other than those listed in Patient Information
`Leaflets. Do not use VASCEPA for a condition for which it was not prescribed. Do not give
`VASCEPA to other people, even if they have the same symptoms you have. It may harm them.
`
`This Patient Information summarizes the most important information about VASCEPA. If you
`would like more information, talk with your doctor or pharmacist. You can ask your doctor or
`pharmacist for information about VASCEPA that is written for health professionals.
`For more information, go to www.vascepa.com or call 1-855-VASCEPA (1-855-827-2372).
`
`What are the ingredients in VASCEPA?
`Active Ingredient: icosapent ethyl
`Inactive Ingredients: tocopherol, gelatin, glycerin, maltitol, sorbitol, and purified water
`This patient information has been approved by the U.S. Food and Drug Administration.
`VASCEPA is a trademark of Amarin Pharmaceuticals Ireland Ltd.
`©2012 Amarin Pharmaceuticals Ireland Ltd.
`PP00120A
`07/2012
`
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`
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`Distributed by:
`Amarin Pharma Inc.
`
`
`Reference ID: 3165067
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`Page 11 of 12
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`Case 1:20-cv-01630-RGA Document 1-5 Filed 11/30/20 Page 13 of 13 PageID #: 87
`
`Bedminster, NJ, USA
`Manufactured by:
`Banner Pharmacaps
`Tilburg, The Netherlands
`
`Manufactured for:
`Amarin Pharmaceuticals Ireland Limited
`Dublin, Ireland
`+1-855-VASCEPA (+1-855-827-2372)
`www.vascepa.com
`
`
`
`Reference ID: 3165067
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`Page 12 of 12
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