Side effects of lovasa

Lovaza

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 4/26/2019

Lovaza (omega-3-acid ethyl esters) is a combination of fatty acids used together with diet and exercise to help lower triglyceride levels in the blood. Lovaza is made of omega-3 polyunsaturated fatty acids, which are found in oil from fish, vegetables, and other plant sources. These fatty acids are not made by the body and must be consumed in the diet. Common side effects of Lovaza include:

  • back pain,
  • upset stomach,
  • burping,
  • skin rash, and
  • unusual or unpleasant taste in your mouth.

Tell your doctor if you experience rare but very serious side effects of Lovaza including:

  • easy bleeding/bruising,
  • black or tarry stool, or
  • vomit that looks like coffee grounds.

The daily dose of Lovaza is 4 grams per day, taken as a single 4-gram dose (4 capsules) or as two 2-gram doses (2 capsules given twice daily). Lovaza may interact with birth control pills or hormone replacement, blood thinners, beta-blockers, or diuretics (water pills). Tell your doctor all medications you use. Lovaza should be used only when prescribed during pregnancy. It is not known if this medication passes into breast milk. Consult your doctor before breastfeeding.

Our Lovaza (omega-3-acid ethyl esters) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Lovaza Side Effects

Generic Name: omega-3 polyunsaturated fatty acids

Medically reviewed by Drugs.com. Last updated on Dec 12, 2018.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

Note: This document contains side effect information about omega-3 polyunsaturated fatty acids. Some of the dosage forms listed on this page may not apply to the brand name Lovaza.

In Summary

More frequent side effects include: dysgeusia and eructation. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to omega-3 polyunsaturated fatty acids: oral capsule liquid filled

Along with its needed effects, omega-3 polyunsaturated fatty acids (the active ingredient contained in Lovaza) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking omega-3 polyunsaturated fatty acids:

Incidence not known

  • Bleeding gums
  • cough
  • coughing up blood
  • difficulty with breathing or swallowing
  • dizziness
  • fast or irregular heartbeat
  • headache
  • hives, itching, or skin rash
  • increased menstrual flow or vaginal bleeding
  • nosebleeds
  • paralysis
  • prolonged bleeding from cuts
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red or black, tarry stools
  • red or dark brown urine
  • sweating
  • tightness in the chest
  • unusual tiredness or weakness

Some side effects of omega-3 polyunsaturated fatty acids may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  • Acid or sour stomach
  • bad, unusual, or unpleasant (after) taste
  • belching
  • bloated or full feeling
  • change in taste
  • excess air or gas in the stomach
  • heartburn
  • indigestion
  • stomach discomfort, upset, or pain

Incidence not known

  • Diarrhea
  • difficulty having a bowel movement (stool)
  • loss of appetite
  • nausea or vomiting
  • passing of gas
  • stomach fullness

For Healthcare Professionals

Applies to omega-3 polyunsaturated fatty acids: oral capsule, oral delayed release capsule, oral kit, oral liquid, oral tablet chewable

Gastrointestinal

Common (1% to 10%): Eructation, dyspepsia, nausea, gastrointestinal disorders (including abdominal distension, abdominal pain, constipation, diarrhea, flatulence, gastroesophageal reflux disease, vomiting)

Uncommon (0.1% to 1%): Gastrointestinal hemorrhage, gastroenteritis

Rare (less than 0.1%): Gastrointestinal pain

Very rare (less than 0.01%): Lower gastrointestinal hemorrhage

General

The most common adverse events were eructation, dyspepsia, and taste perversion

Other

Common (1% to 10%): Infection, pain

Uncommon (0.1% to 1%): Death

Dermatologic

Common (1% to 10%): Rash

Uncommon (0.1% to 1%): Atopic dermatitis

Rare (less than 0.1%): Urticaria, acne, rash pruritic

Frequency not reported: Pruritus

Cardiovascular

Uncommon (0.1% to 1%): Hypotension

Musculoskeletal

Common (1% to 10%): Back pain

Metabolic

Uncommon (0.1% to 1%): Hyperglycemia, gout, high triglycerides

Very rare (less than 0.01%): Blood lactate dehydrogenase increased

Nervous system

Common (1% to 10%): Taste perversion

Uncommon (0.1% to 1%): Dizziness, dysgeusia, headache, hyperactivity

Respiratory

Uncommon (0.1% to 1%): Epistaxis

Very rare (less than 0.01%): Nasal dryness

Frequency not reported: Influenza

Hypersensitivity

Rare (less than 0.1%): Hypersensitivity

Postmarketing reports: Anaphylactic reaction

Hematologic

Very rare (less than 0.01%): White blood count increased,

Frequency not reported: Slight prolongation of bleeding time

Postmarketing reports: Hemorrhagic diathesis

Psychiatric

Uncommon (0.1% to 1%): Tics, tantrum, insomnia

Hepatic

Rare (less than 0.1%): Liver disorders (including increased ALT, increased AST, and transaminases increased)

1. “Product Information. Omega-3 D-3 Wellness Pack (omega-3 polyunsaturated fatty acids).” TMIG Inc, Marietta, GA.

2. “Product Information. Omega-3-Acid Ethyl Esters (omega-3 polyunsaturated fatty acids).” Apotex Corporation, Weston, FL.

3. Cerner Multum, Inc. “Australian Product Information.” O 0

4. “Product Information. Lovaza (omega-3 polyunsaturated fatty acids).” GlaxoSmithKline, Research Triangle Park, NC.

5. “Product Information. Vayarin (omega-3 polyunsaturated fatty acids).” Vaya Pharma, Greenville, SC.

6. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer

More about Lovaza (omega-3 polyunsaturated fatty acids)

  • During Pregnancy
  • Dosage Information
  • Drug Images
  • Drug Interactions
  • Compare Alternatives
  • Pricing & Coupons
  • En Español
  • 9 Reviews
  • Generic Availability
  • Drug class: nutraceutical products

Consumer resources

  • Lovaza
  • Lovaza (Advanced Reading)

Other brands: Fish Oil, Nature’s Bounty Red Krill Oil, Prenatal DHA, MegaKrill, … +10 more

Professional resources

  • Lovaza (FDA)
  • … +1 more

Related treatment guides

  • Hypertriglyceridemia
  • Dietary Supplementation

Vascepa vs Lovaza: Main Differences and Similarities

Vascepa and Lovaza are two fish oil treatments that contain omega-3 fatty acids. They can be used to lower triglyceride levels in the blood. High triglyceride levels are linked to an increased risk of heart disease.

Although some fish oil supplements can be purchased over the counter, both Vascepa and Lovaza must be prescribed by a doctor. They are also recommended to be used with an effective diet and exercise plan to further reduce triglycerides.

Vascepa

Vascepa is a brand name medication that can decrease triglyceride levels in those with triglyceride levels over 500 milligrams per deciliter. It contains an ethyl ester of eicosapentaenoic acid (EPA).

Because it does not contain docosahexaenoic acid (DHA), it can lower triglycerides without increasing LDL-C levels. LDL-C is the main type of cholesterol that can clog blood vessels and cause heart attacks and strokes.

Vascepa can be taken as a 0.5 gram or 1 gram oral capsule. The recommended daily dose is 4 grams per day. This can be taken as four 0.5-gram capsules or two 1-gram capsules twice daily.

Vascepa should be taken with food. It is not recommended to crush or chew the capsules.

Lovaza is a prescription fish oil medication that is also used to treat high levels of triglycerides over 500 milligrams per deciliter. It contains ethyl esters of omega-3 fatty acids, primarily EPA and DHA.

Lovaza is available as a 1 gram oral capsule. The recommended daily dose is 4 grams per day. It can be taken as four 1-gram oral capsules at once or two 2-gram doses twice per day.

Unlike Vascepa, Lovaza can be taken with or without food. However, it should not be crushed or chewed.

Vascepa vs Lovaza Side by Side Comparison

Vascepa and Lovaza are two similar acting medications. Although they share similar features, they also have some important differences. Both medications can be reviewed in the comparison table below.

Vascepa Lovaza
Prescribed For
  • High triglycerides (severe hypertriglyceridemia ≥500 mg/dL)
  • High triglycerides (severe hypertriglyceridemia ≥500 mg/dL)
Drug Classification
  • Omega-3 Fatty Acid
  • Omega-3 Fatty Acid
Manufacturer
  • Amarin
  • GlaxoSmithKline
Common Side Effects
  • Joint pain
  • Indigestion
  • Altered sense of taste
  • Burping
Is there a generic?
  • No generic available
  • Generic Lovaza
Is it covered by insurance?
  • Varies according to your provider
  • Varies according to your provider
Dosage Forms
  • Oral capsule
  • Oral capsule
Average Cash Price
  • $311 (per 120 capsules)
  • $229 (per 120 capsules)
SingleCare Discount Price
  • Vascepa Price
  • Lovaza Price
Drug Interactions
  • Anticoagulants (warfarin, apixaban, dabigatran, etc.)
  • Antiplatelet agents (aspirin, clopidogrel, etc.)
  • Anticoagulants (warfarin, apixaban, dabigatran, etc.)
  • Antiplatelet agents (aspirin, clopidogrel, etc.)
Can I use while planning pregnancy, pregnant, or breastfeeding?
  • Vascepa is in Pregnancy Category C. Fetal harm cannot be ruled out. Consult a physician regarding taking Vascepa while pregnant or breastfeeding.
  • Lovaza is in Pregnancy Category C. Fetal harm cannot be ruled out. Consult a physician regarding taking Lovaza while pregnant or breastfeeding.

Summary

Vascepa and Lovaza are two options that can treat high triglyceride levels. Their main differences are in their chemical makeup and side effects.

Vascepa may be preferred for some individuals because it contains pure eicosapentaenoic acid (EPA). It does not contain DHA, an omega-3 fat that can affect LDL cholesterol levels. Therefore, if high LDL cholesterol is a concern, Vascepa may be a better option.

Vascepa may cause side effects such as joint pain. It may also be more expensive than Lovaza. These potential downsides can alter the decision to use Vascepa.

Lovaza contains the omega-3 fats, EPA and DHA. While it is an effective treatment option to decrease high triglyceride levels, it may increase LDL cholesterol in the blood. This may be a concern for those with a high risk of heart disease.

The main side effects of Lovaza include burping and indigestion. Some people also experience an aftertaste with Lovaza.

Both Vascepa and Lovaza should be used with caution when anticoagulants are also being taken. These drugs can cause an increased risk of bleeding if they are used together.

Both medications should only be used under the supervision of a doctor. It is important to discuss your overall condition to determine the best option for you.

Generic Name: omega-3-acid ethyl esters
Dosage Form: capsule, liquid filled

Medically reviewed by Drugs.com. Last updated on Apr 1, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

Indications and Usage for Lovaza

Lovaza (omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg per dL) hypertriglyceridemia (HTG).

Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving Lovaza and should continue this diet during treatment with Lovaza.

Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with Lovaza. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy.

Limitations of Use:

The effect of Lovaza on the risk for pancreatitis has not been determined.

The effect of Lovaza on cardiovascular mortality and morbidity has not been determined.

Lovaza Dosage and Administration

• Assess triglyceride levels carefully before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, medications) of high triglyceride levels and manage as appropriate . • Patients should be placed on an appropriate lipid-lowering diet before receiving Lovaza, and should continue this diet during treatment with Lovaza. In clinical studies, Lovaza was administered with meals.

The daily dose of Lovaza is 4 grams per day. The daily dose may be taken as a single 4-gram dose (4 capsules) or as two 2-gram doses (2 capsules given twice daily).

Patients should be advised to swallow Lovaza capsules whole. Do not break open, crush, dissolve, or chew Lovaza.

Dosage Forms and Strengths

Lovaza (omega-3-acid ethyl esters) capsules are supplied as 1-gram transparent, soft-gelatin capsules filled with light-yellow oil and bearing the designation “GS FH2”.

Contraindications

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

Warnings and Precautions

Monitoring: Laboratory Tests

In patients with hepatic impairment, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be monitored periodically during therapy with Lovaza. In some patients, increases in ALT levels without a concurrent increase in AST levels were observed.

In some patients, Lovaza increases low-density lipoprotein cholesterol (LDL-C) levels. LDL-C levels should be monitored periodically during therapy with Lovaza.

Laboratory studies should be performed periodically to measure the patient’s TG levels during therapy with Lovaza.

Fish Allergy

Lovaza contains ethyl esters of omega-3 fatty acids (EPA and DHA) obtained from the oil of several fish sources. It is not known whether patients with allergies to fish and/or shellfish, are at increased risk of an allergic reaction to Lovaza. Lovaza should be used with caution in patients with known hypersensitivity to fish and/or shellfish.

Recurrent Atrial Fibrillation (AF) or Flutter

In a double-blind, placebo-controlled trial of 663 subjects with symptomatic paroxysmal AF (n = 542) or persistent AF (n = 121), recurrent AF or flutter was observed in subjects randomized to Lovaza who received 8 grams per day for 7 days and 4 grams per day thereafter for 23 weeks at a higher rate relative to placebo. Subjects in this trial had median baseline triglycerides of 127 mg per dL, had no substantial structural heart disease, were taking no anti-arrhythmic therapy (rate control permitted), and were in normal sinus rhythm at baseline.

At 24 weeks, in the paroxysmal AF stratum, there were 129 (47%) first recurrent symptomatic AF or flutter events on placebo and 141 (53%) on Lovaza (primary endpoint, HR 1.19; 95% CI: 0.93, 1.35). In the persistent AF stratum, there were 19 (35%) events on placebo and 34 (52%) events on Lovaza (HR 1.63; 95% CI: 0.91, 2.18). For both strata combined, the HR was 1.25; 95% CI: 1.00, 1.40. Although the clinical significance of these results is uncertain, there is a possible association between Lovaza and more frequent recurrences of symptomatic atrial fibrillation or flutter in patients with paroxysmal or persistent atrial fibrillation, particularly within the first 2 to 3 months of initiating therapy.

Lovaza is not indicated for the treatment of AF or flutter.

Adverse Reactions

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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse reactions reported in at least 3% of subjects treated with Lovaza and at a greater rate than placebo based on pooled data across 23 clinical trials are listed in Table 1.

Table 1. Adverse Reactions Occurring at Incidence ≥3% and Greater than Placebo in Clinical Trials of Lovaza

a Trials included subjects with HTG and severe HTG.

Adverse Reactiona

Lovaza

(n = 655)

Placebo

(n = 370)

n

%

n

%

Eructation

Dyspepsia

Taste perversion

<1

Additional adverse reactions from clinical trials are listed below:

Digestive System

Constipation, gastrointestinal disorder, and vomiting.

Metabolic and Nutritional Disorders

Increased ALT and increased AST.

Skin

Pruritus and rash.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the events described below have been identified during post-approval use of Lovaza. Because these events are reported voluntarily from a population of unknown size, it is not possible to reliably estimate their frequency or to always establish a causal relationship to drug exposure.

The following events have been reported: anaphylactic reaction, hemorrhagic diathesis, urticaria.

Drug Interactions

Anticoagulants or Other Drugs Affecting Coagulation

Some trials with omega-3-acids demonstrated prolongation of bleeding time. The prolongation of bleeding time reported in these trials has not exceeded normal limits and did not produce clinically significant bleeding episodes. Clinical trials have not been done to thoroughly examine the effect of Lovaza and concomitant anticoagulants. Patients receiving treatment with Lovaza and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. It is unknown whether Lovaza can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Lovaza should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus.

Animal Data

Omega-3-acid ethyl esters have been shown to have an embryocidal effect in pregnant rats when given in doses resulting in exposures 7 times the recommended human dose of 4 grams per day based on a body surface area comparison.

In female rats given oral gavage doses of 100, 600, and 2,000 mg per kg per day beginning 2 weeks prior to mating and continuing through gestation and lactation, no adverse effects were observed in the high-dose group (5 times human systemic exposure following an oral dose of 4 grams per day based on body surface area comparison).

In pregnant rats given oral gavage doses of 1,000, 3,000, and 6,000 mg per kg per day from gestation Day 6 through 15, no adverse effects were observed (14 times human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison).

In pregnant rats given oral gavage doses of 100, 600, and 2,000 mg per kg per day from gestation Day 14 through lactation Day 21, no adverse effects were seen at 2,000 mg per kg per day (5 times the human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison). However, decreased live births (20% reduction) and decreased survival to postnatal Day 4 (40% reduction) were observed in a dose-ranging study using higher doses of 3,000 mg per kg per day (7 times the human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison).

In pregnant rabbits given oral gavage doses of 375, 750, and 1,500 mg per kg per day from gestation Day 7 through 19, no findings were observed in the fetuses in groups given 375 mg per kg per day (2 times human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison). However, at higher doses, evidence of maternal toxicity was observed (4 times human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison).

Nursing Mothers

Studies with omega-3-acid ethyl esters have demonstrated excretion in human milk. The effect of this excretion on the infant of a nursing mother is unknown; caution should be exercised when Lovaza is administered to a nursing mother. An animal study in lactating rats given oral gavage 14C-ethyl EPA demonstrated that drug levels were 6 to 14 times higher in milk than in plasma.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

A limited number of subjects older than 65 years were enrolled in the clinical trials of Lovaza. Safety and efficacy findings in subjects older than 60 years did not appear to differ from those of subjects younger than 60 years.

Drug Abuse and Dependence

Lovaza does not have any known drug abuse or withdrawal effects.

Lovaza Description

Lovaza, a lipid-regulating agent, is supplied as a liquid-filled gel capsule for oral administration. Each 1-gram capsule of Lovaza contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA — approximately 465 mg) and docosahexaenoic acid (DHA — approximately 375 mg).

The empirical formula of EPA ethyl ester is C22H34O2, and the molecular weight of EPA ethyl ester is 330.51. The structural formula of EPA ethyl ester is:

The empirical formula of DHA ethyl ester is C24H36O2, and the molecular weight of DHA ethyl ester is 356.55. The structural formula of DHA ethyl ester is:

Lovaza capsules also contain the following inactive ingredients: 4 mg α-tocopherol (in a carrier of soybean oil), and gelatin, glycerol, and purified water (components of the capsule shell).

Lovaza – Clinical Pharmacology

Mechanism of Action

The mechanism of action of Lovaza is not completely understood. Potential mechanisms of action include inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase, increased mitochondrial and peroxisomal β-oxidation in the liver, decreased lipogenesis in the liver, and increased plasma lipoprotein lipase activity. Lovaza may reduce the synthesis of triglycerides in the liver because EPA and DHA are poor substrates for the enzymes responsible for TG synthesis, and EPA and DHA inhibit esterification of other fatty acids.

Pharmacokinetics

Absorption

In healthy volunteers and in subjects with hypertriglyceridemia, EPA and DHA were absorbed when administered as ethyl esters orally. Omega-3-acids administered as ethyl esters (Lovaza) induced significant dose-dependent increases in serum phospholipid EPA content, though increases in DHA content were less marked and not dose-dependent when administered as ethyl esters.

Specific Populations

Age: Uptake of EPA and DHA into serum phospholipids in subjects treated with Lovaza was independent of age (younger than 49 years versus 49 years and older).

Male and Female Patients: Females tended to have more uptake of EPA into serum phospholipids than males. The clinical significance of this is unknown.

Pediatric Patients: Pharmacokinetics of Lovaza have not been studied.

Patients with Renal or Hepatic Impairment: Lovaza has not been studied in patients with renal or hepatic impairment.

Drug Interaction Studies

Simvastatin: In a 14-day trial of 24 healthy adult subjects, daily coadministration of simvastatin 80 mg with Lovaza 4 grams did not affect the extent (AUC) or rate (Cmax) of exposure to simvastatin or the major active metabolite, beta-hydroxy simvastatin, at steady state.

Atorvastatin: In a 14-day trial of 50 healthy adult subjects, daily coadministration of atorvastatin 80 mg with Lovaza 4 grams did not affect AUC or Cmax of exposure to atorvastatin, 2-hydroxyatorvastatin, or 4-hydroxyatorvastatin at steady state.

Rosuvastatin: In a 14-day trial of 48 healthy adult subjects, daily coadministration of rosuvastatin 40 mg with Lovaza 4 grams did not affect AUC or Cmax of exposure to rosuvastatin at steady state.

In vitro studies using human liver microsomes indicated that clinically significant cytochrome P450-mediated inhibition by EPA/DHA combinations are not expected in humans.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a rat carcinogenicity study with oral gavage doses of 100, 600, and 2,000 mg per kg per day, males were treated with omega-3-acid ethyl esters for 101 weeks and females for 89 weeks without an increased incidence of tumors (up to 5 times human systemic exposures following an oral dose of 4 grams per day based on a body surface area comparison). Standard lifetime carcinogenicity bioassays were not conducted in mice.

Omega-3-acid ethyl esters were not mutagenic or clastogenic with or without metabolic activation in the bacterial mutagenesis (Ames) test with Salmonella typhimurium and Escherichia coli or in the chromosomal aberration assay in Chinese hamster V79 lung cells or human lymphocytes. Omega-3-acid ethyl esters were negative in the in vivo mouse micronucleus assay.

In a rat fertility study with oral gavage doses of 100, 600, and 2,000 mg per kg per day, males were treated for 10 weeks prior to mating and females were treated for 2 weeks prior to and throughout mating, gestation, and lactation. No adverse effect on fertility was observed at 2,000 mg per kg per day (5 times human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison).

Clinical Studies

Severe Hypertriglyceridemia

The effects of Lovaza 4 grams per day were assessed in 2 randomized, placebo-controlled, double-blind, parallel-group trials of 84 adult subjects (42 on Lovaza, 42 on placebo) with very high triglyceride levels. Subjects whose baseline triglyceride levels were between 500 and 2,000 mg per dL were enrolled in these 2 trials of 6 and 16 weeks’ duration. The median triglyceride and LDL-C levels in these subjects were 792 mg per dL and 100 mg per dL, respectively. Median high-density lipoprotein cholesterol (HDL-C) level was 23.0 mg per dL.

The changes in the major lipoprotein lipid parameters for the groups receiving Lovaza or placebo are shown in Table 2.

Lovaza 4 grams per day reduced median TG, VLDL-C, and non-HDL-C levels and increased median HDL-C from baseline relative to placebo. Treatment with Lovaza to reduce very high TG levels may result in elevations in LDL-C and non-HDL-C in some individuals. Patients should be monitored to ensure that the LDL-C level does not increase excessively.

The effect of Lovaza on the risk of pancreatitis has not been determined.

The effect of Lovaza on cardiovascular mortality and morbidity has not been determined.

How Supplied/Storage and Handling

Lovaza (omega-3-acid ethyl esters) capsules are supplied as 1-gram, transparent, soft-gelatin capsules filled with light-yellow oil and bearing the designation “GS FH2”.

Bottles of 120: NDC 0173-0884-08.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Do not freeze. Keep out of reach of children.

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Information for Patients

• Lovaza should be used with caution in patients with known sensitivity or allergy to fish and/or shellfish . • Advise patients that use of lipid-regulating agents does not reduce the importance of adhering to diet . • Advise patients not to alter Lovaza capsules in any way and to ingest intact capsules only . • Instruct patients to take Lovaza as prescribed. If a dose is missed, advise patients to take it as soon as they remember. However, if they miss one day of Lovaza, they should not double the dose when they take it.

Manufactured for:

GlaxoSmithKline

Research Triangle Park, NC 27709

Trademarks are owned by or licensed to the GSK group of companies.

©2019 GSK group of companies or its licensor.

LVZ:14PI

PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ _

PATIENT INFORMATION

Lovaza (LO-VA-ZA)

(omega-3-acid ethyl esters capsules)

What is Lovaza?

Lovaza is a prescription medicine used along with a low-fat and low-cholesterol diet to lower very high triglyceride (fat) levels in adults.

It is not known if Lovaza changes your risk of having inflammation of your pancreas (pancreatitis).

It is not known if Lovaza prevents you from having a heart attack or stroke.

It is not known if Lovaza is safe and effective in children.

Who should not take Lovaza?

Do not take Lovaza if you are allergic to omega-3-acid ethyl esters or any of the ingredients in Lovaza. See the end of this leaflet for a complete list of ingredients in Lovaza.

Before taking Lovaza, tell your healthcare provider about all of your medical conditions, including if you:

• have diabetes. • have a low thyroid problem (hypothyroidism). • have a liver problem. • have a pancreas problem. • have a certain heart rhythm problem called atrial fibrillation or flutter. • are allergic to fish or shellfish. It is not known if people who are allergic to fish or shellfish are also allergic to Lovaza. • are pregnant or plan to become pregnant. It is not known if Lovaza will harm your unborn baby. • are breastfeeding or plan to breastfeed. Lovaza can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Lovaza.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Lovaza can interact with certain other medicines that you are taking. Using Lovaza with medicines that affect blood clotting (anticoagulants or blood thinners) may cause serious side effects.

How should I take Lovaza?

• Take Lovaza exactly as your healthcare provider tells you to take it. • You should not take more than 4 capsules of Lovaza each day. Either take all 4 capsules at one time or 2 capsules two times a day. • Do not change your dose or stop Lovaza without talking to your healthcare provider. • Take Lovaza with food. • Take Lovaza capsules whole. Do not break, open, crush, dissolve, or chew Lovaza capsules before swallowing. If you cannot swallow Lovaza capsules whole, tell your healthcare provider. You may need a different medicine. • If you miss a dose of Lovaza, take the missed dose as soon as you remember. If you miss one day of Lovaza, do not double your dose the next time you take it. • Your healthcare provider may start you on a cholesterol-lowering diet before giving you Lovaza. Stay on this diet while taking Lovaza. • Your healthcare provider should do blood tests to check your triglyceride, bad cholesterol (LDL-C), and liver function (ALT and AST) levels while you take Lovaza.

What are the possible side effects of Lovaza?

Lovaza may cause serious side effects, including:

• changes in certain blood tests. Lovaza may cause an increase in the results of blood tests used to check your liver function and your bad cholesterol levels. • increased risk of a heart rhythm problem in people who have a heart rhythm problem. Lovaza may cause an increase in the frequency of a heart rhythm problem (atrial fibrillation or flutter), especially in the first few months of taking Lovaza, if you already have a heart rhythm problem.

The most common side effects of Lovaza include:

• burping • upset stomach • a change in your sense of taste

These are not all the possible side effects of Lovaza.

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 Lovaza?

• Store Lovaza at room temperature between 68°F to 77°F (20°C to 25°C). • Do not freeze Lovaza. • Safely throw away medicine that is out of date or no longer needed.

Keep Lovaza and all medicines out of the reach of children.

General information about the safe and effective use of Lovaza.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Lovaza for a condition for which it was not prescribed. Do not give Lovaza to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about Lovaza that is written for health professionals.

What are the ingredients in Lovaza?

Active Ingredient: omega-3-acid ethyl esters, mostly EPA and DHA

Inactive Ingredients: alpha-tocopherol (in soybean oil), gelatin, glycerol, purified water.

Manufactured for:

GlaxoSmithKline

Research Triangle Park, NC 27709
Trademarks are owned by or licensed to the GSK group of companies.

©2019 GSK group of companies or its licensor.

LVZ:12PIL

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 4/2019

PRINCIPAL DISPLAY PANEL

NDC 0173-0783-02

Lovaza®

(omega-3-acid ethyl esters)

Capsules

Rx only

Swallow capsules whole.

120 Capsules

Each capsule contains 1 gram omega-3-acid ethyl ester liquid concentrate consisting of at least 900 mg omega-3-acid ethyl esters.

Each capsule provides: Eicosapentaenoic acid (EPA) ethyl ester: 465 mg

Docosahexaenoic acid (DHA) ethyl ester: 375 mg

Usual Dosage: See accompanying prescribing information.

Store at 25oC (77oF); excursions permitted to 15o-30oC (59o-86oF) . Do not freeze.

Do not accept if seal on bottle opening is missing or broken.

Manufactured for:

GlaxoSmithKline

RTP, NC 27709

Made in Norway

Rev. 9/14

A127667

PRINCIPAL DISPLAY PANEL

NDC 0173-0884-08

Lovaza®

(omega-3-acid ethyl esters)

Capsules

Rx only

Swallow capsules whole.

120 Capsules

Each capsule contains 1 gram omega-3-acid ethyl ester liquid concentrate consisting of at least 900 mg omega-3-acid ethyl esters.

Each capsule provides: Eicosapentaenoic acid (EPA) ethyl ester: 465 mg

Docosahexaenoic acid (DHA) ethyl ester: 375 mg

Usual Dosage: See accompanying prescribing information.

Store at 25oC (77oF); excursions permitted to 15o-30oC (59o-86oF) . Do not freeze.

Do not accept if membrane seal under cap is missing or broken.

Manufactured for:

GlaxoSmithKline

RTP, NC 27709

Made in Norway

Rev. 1/17

Lovaza
omega-3-acid ethyl esters capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0173-0783
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEGA-3-ACID ETHYL ESTERS (OMEGA-3 FATTY ACIDS) OMEGA-3-ACID ETHYL ESTERS 900 mg
Inactive Ingredients
Ingredient Name Strength
.ALPHA.-TOCOPHEROL
GELATIN, UNSPECIFIED
GLYCERIN
WATER
Product Characteristics
Color YELLOW (light yellow) Score no score
Shape CAPSULE Size 24mm
Flavor Imprint Code Lovaza
Contains
Packaging
# Item Code Package Description
1 NDC:0173-0783-02 120 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021654 10/21/2008 10/31/2019
Lovaza
omega-3-acid ethyl esters capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0173-0884
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEGA-3-ACID ETHYL ESTERS (OMEGA-3 FATTY ACIDS) OMEGA-3-ACID ETHYL ESTERS 900 mg
Inactive Ingredients
Ingredient Name Strength
.ALPHA.-TOCOPHEROL
GELATIN, UNSPECIFIED
GLYCERIN
WATER
Product Characteristics
Color YELLOW (light yellow) Score no score
Shape CAPSULE Size 24mm
Flavor Imprint Code GS;FH2
Contains
Packaging
# Item Code Package Description
1 NDC:0173-0884-08 120 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021654 05/19/2016

Labeler – GlaxoSmithKline LLC (167380711)

GlaxoSmithKline LLC

Medical Disclaimer

  • Side Effects
  • During Pregnancy
  • Dosage Information
  • Drug Images
  • Drug Interactions
  • Compare Alternatives
  • Pricing & Coupons
  • En Español
  • 9 Reviews
  • Generic Availability
  • Drug class: nutraceutical products
  • Lovaza
  • Lovaza (Advanced Reading)
  • Omega-3-acid Ethyl Esters (AHFS Monograph)
  • Omega-3-Acid Ethyl Esters (FDA)

Other brands: Omacor, Epanova, Divista, Omtryg, … +4 more

  • Hypertriglyceridemia
  • Dietary Supplementation

Seattle Personal Injury Attorney | Martin Law PLLC

In men it is more likely than women in the ears

The affected area may appear to touch the rough, much less – similar to a wart or around; spots, mostly small, can spread quite widely 5-10% of cases, become skin cancer, squamous cells (see fig Below) The ability of the elderly to fight bacterial and viral infections is reduced In addition to the age-related decline in the arrangement of the internal organs of the body, the ability to stay with a certain tension decreases, even the immune system loses some of its strength and speed of response to infection by production slowly antibody Lymphocytes – cells that decline shouldnt strange attack, but respond to invade are less active Do not try to predict how people will take their message Many in the beginning of the unrest and compassionate, and later support the same relationship as before, sometimes interested in their welfare and possible advances in treatment You can expect thoughtless and encouragement, such as “I am convinced that in the end will be in all the right stories’ and unpleasant friends who have had cancer, too Even if you are not interested, kindly heard everything L L About 6 to 8 glasses of pure water a day leads to a complete mechanism of the digestive tract in an effective operation, disappears hunger and desire to do something craze A small growth of sports or summer heat this normu

Nikturiya Sbor antiseptic Peppermint contain equal parts bar, sage, thyme and stalks Usually, I insisted on it, prepared from the bathroom, and often fall back on the first cleaning, to disinfect the room, and at the same time in the wash If the couple has had regular visits, and becomes dry and softness fat, on the other hand, dry skin how much vitamin in similar to 1000 mg what used is there a generic discount over the counter cost lovaza buy online no prescription retail price of best for package insert walmart pharmacy drug medication order costco name. I must say that bathroom “training” has a positive effect on the skin of any type, and make it possible to come closer to the ideal And KP Buteyko: “In all cases, the answer is do not give a little more statistics, but individual cases of recovery, including leukemia, cancer of the blood

The use of modern sponges sponges

If you suspect that the same thing for hip fracture, and a broken pelvis tires Tires should be for a longer period It is applied on the outside of the leg, and the second – from the thigh to foot, and then they fixed with a bandage or other materials available The victim should be careful of causing the pelvis, pass wide panel or other object with an apartment and bring them to the car, “ambulance”, is advised Blyuda fresh nettles plant for use with HIV patients BARRE wild metabolic disorders as well as chronic ustalosti Etot thirst tea provides the body with useful substances It takes 3 parts dried herbs, mint and oregano St John, it rose 1 elderberry dried black berries and wild part 50 grams accounts for 1 liter kipyatka Priemov reported using a vacuum are not limited to: opahivanie stroking postegivanie, pohlestyvanie, compression, expansion, and heavy Best of all, when they are used together for ocheredi

V bathroom, and when increased blood flow, the skin becomes softer, all kinds of inflammation, and increases its acidity Steam helps to fight acne, which is very difficult to get rid of In addition, it is the skin removed the shower so the bacteria, dust and dead skin cells and skin separation, which often cause blockage of pores and vospaleniy Pomimo different things, women carefully to ensure that the fire did not It spreads to the oven wall or on the ground (made from wood shower) I must say that a built entirely of wood in the old baths, and the tree of the material available in our country In most cases, that will be used for this purpose or birch lipu V medication, only one species – burdock (burdock big L ) “Few people know that the best source of calcium is not lime and chalk (though it is also used), and the shell of chicken eggs washed with soap and water and fat in hot water pot with AZ in a mortar and sprinkle on food or just chewing and swallowing “(10) It is known that the compositions of hair dye and nail polish are not sure about the penetration of the blood of harmful substances, and the whole organism Rausch Sobrannye from parts of the plant can be frozen or suspended Is collected for these securities wash only, finely chopped, put in a bowl, and refrigeration 1 recipe 1 tablespoon dried plant nettle leaves pour 1 cup hot water The ability to cover with a thick cloth and insist 7-8 hours Pump filter and take 1 tbsp 3 times a day for 30 to 40 minutes before eating

Infusion may be different krovotecheniyah

Na each of the major oil blocks the ball used randomly, with a slight indentation on the top cover The edges of the urgent need to hack pack Then add the spices, salt, minced meat production, dip in beaten egg, and then – in bread crumbs (crumbs should be a lot of oil does not flow from pieces) Then fry patties in a large amount of oil or other fat A potato dish suitable, fried in butter Decorate the dish can be green beans, cover and branches boiled eggs zeleni Ne classes as long as their disease does not disappear completely, and I would probably break through, 3-5 minutes at least If you are really stupid, the same room is not the desired result, but along with diet, massage, and the effect of physical exercise buy z-pack online uk without prescription may be just amazing It distorts not only the name but also the principle and essence of this process over the counter equivalent to ruling health 1000 mg cost online best how much can lower triglycerides prescription assistance programs for lovaza canada pharmacy price medication generic 1 gm capsule cvs data us is available in sale Unfortunately this was not done by the Ministry of Health in the Soviet Union, without permission of the author So I lost a part in the book

I wrote and asked stopped transmitting instructions without prior training of doctors and we are now in place, illiteracy documents that are created, and the main concern – to neutralize the name ” Kurs – 1-2 months soup is dandruff, hair excessive oil use and lack rosta without canadian pharmacy coupon price lovaza purchase no prescription strength fish oil canada cheapest fish oil does a prescription help canada 4000 mg over the counter substitute for how much lovaza should i take generic alternative to where can buy price of capsules retail cost omega-3-acid ethyl esters purchase online order without no vascepa vs substitute why is only cheapest for online classification fish oil available generic price buy lovaza without prescription cheap average cost of canada discount drug class medication called Edinstvenny needle to improve vacuum – in the steam room resin under the influence of heat and steam vacuum needle just beginning to bleed resin, the worst when it hits the hair even if you submit to. non cost of drug for uk cholesterol medications order online no prescription how much fat is in lovaza 4 mg 1 costco price apotex generic purchase cheap without pharmacy coupon sale teva dha. to take advantage of spruce branches, it is necessary to wear special gloves, and when it gets to the resin on the skin after a shower, you can remove it with a cotton swab dipped in alcohol or vodkoy takzhe bathroom and helps the kidneys in the body to get rid of undesirable materials and water that go along with sweat for example, when they accumulate excess fat in the pores, and this can lead to the formation of acne, which is slozhno Itak to get rid of enough, you know, losing weight, and because of loss of water in the basin is happening in the first place, and sweat from passing through the pores in the template in principle, the race can be in any bathroom, but it is best to dry air bath to lose weight to use (or Russian sauna stove without a bit of delivery)

If air saturated with water vapor, it will be reduced sweat – the good, the body should be invited neumolimy uses generic without canada price online no pharmacy mg fish oil prescription lovaza where to buy cheap buyout walmart of at Odnako laws of physics only after you have warmed properly (ie good hot. )

One way for this little boy

It should have three or four times muffled, as they say in the bones, and only then ohlazhdatsya Holodnye perfusion allergies can cause In this case, help antihistamines, warm clothes and warm chay 12 Skurihin Ch M , MN Volgarev interesting that the chemical composition in the Royal Baths Do not use plain water, bread and drinks or beer to keep the pair In addition, she chopped and placed in a bath of juniper branches, pine bark, herbs and flowers Modern bathrooms can keep and use the humidity in the air cooking herbs POKAZANIYaOstorozhno, sauna! iymed.com Giperholisterinemiya Tahikardiya

.

Bani mentioned in the “tale of bygone years” (twelfth century) The facts are known to be the time of Kievan Rus’ Princess Olga, burned blocked in retaliation for her husband, Igor, with a bathroom drevlyanami Izdavna bathroom was a place for people to help by trained persons or special ordering for bring her skin, nails and hair training In today’s world it is not lost its meaning iPad is still one of the best destinations Steam cosmetic procedures and cleaned of toxins and horny layer of skin cosmetics body easily Evenshteyn dietetics obrabotke

REAKTsII VYZDOROVLENIYA18 are popular M EM

. economy, 1990 “If you have allergies, spasms and pain, you know that you reduced calcium in the blood “(5) war Pech bathroom without black pipe so that the smoke and soot goes directly to the steam room From this, the walls and ceiling were covered with soot steam return quickly that it was impossible to walk wash This is the black color of the walls and ceiling Bath got its name – the “black” data Skladyvat in firewood needs air circulation rolled between rows and provide wood and between Poleshko cost to take how much epa and dha in dosage buy without lovaza online pharmacy no prescription coupon generic savings card assistance mg. In any case, libraryrx.com They do not cover the timber with plastic wrap or a piece of tarpaulin, otherwise the tree will begin gnit dha does have usa fish oil equals buy canada cost of cheap online no many mg how much vitamin d is in lovaza prescription assistance program coupon over the counter comparable to non teva generic equivalent for alternative omega 3 price coupons medication do i need a Uluchshenie state when these diseases occurred in the near future, but a full recovery process depends on the duration of the disease and the care with which they were working patients traditions after falling VLGD Odna Russian baths wash in cold water party http://kemist.net/without-prescription-online/sildenafil-citrate.html Today, this tradition has not lost its importance, and many believe that cold water completely hardens the body and strengthens the immune sistemu Vozmite equal parts of mint, sage, thyme and eucalyptus, with boiling water and let it brew

This aromatic plant in the air a lot of food, which destroy in combination with high temperatures almost all the bacteria on the skin and upper respiratory putyah.

teva launches generic brand much is omega 3 order cheapest place how to get free online without prescription fish oil buy lovaza coupon cost of at walmart cheap para que se usa side effects over the counter replacement for price comparison where canada cheaper alternative V large enamel pan, pour a mixture of herbs, leaves, pour all with boiling water and put on high heat lower triglycerides 1 mg side effects when will generic be available type of mail order where can i buy fish oil purchase online without how much does cost lovaza medication coupon 500mg prescription omega 3 what is the used for cheap no price in india assistance ethyl esters 1000 Once the water boils, turn the flame to a minimum by closing the pan bottom and a lid

Soup simmer for 40 minutes

Then the pot, without removing the cover, remove from heat and allow to cool broth and clamp inserted through a sieve, mixed with vegetable crush with a spoon or tolkushkoy Then let the broth through a cheesecloth and pour into bottles to be closed and sealed If you want to prepare boiled in the future, http://kemist.net/without-prescription-online/fluoxetine.html it is necessary to add a bit of alcohol, otherwise it will deteriorate rapidly Keep it in a cool, dark 11 / 2-2 months, there should be just that in all actions bathrooms 100 grams in a bowl of hot vody Bannye process always require start with a warm shower easy to heat the body and prepare for high-temperature steam Washing with soap and water before the first steam inlet is not nuzhno Slovo “sponge” Initially, of course, Russian This happened in “mchati” the meaning of the verb “hit almost http://iymed.com/cost-of-no-prescription/mobic.html tear the fibers ” Like many words, it is collected slogans as people in the word “sponge”! “Cola urine starts again”, “Shu bark” To tell the truth, and grandparents have long towel, and believed in the bathroom and do not use nechego Ne lower value and burdock purchase 1000 mg coupon side effects lovaza medication price buy no prescription online without how much omega 3 in cost of generic name fish oil

price buy canada cholesterol medication cost of how much fish oil is in lovaza online generic medicine for a prescription drug order to get coupon australia where no india the therapeutic properties of people are used worldwide For example, burdock is used to treat various diseases of the skin, rheumatism and improve the digestive system, stomach ulcers and duodenal ulcers and other glands of the endocrine, which developed due to insufficient amounts of insulin – a disease pancreatic hormones Manifested in violation of carbohydrates, fats and proteins obmena Ne can cut the top of the tree, because the upper branches are usually flexible and bite Their respective vacuum, and looks more like a whip Top Affiliates – those that grow close to the ground, which is that they need to and have passed since the discovery of srezat

Gipotoniya

Polveka way KP Buteyko, and take a look around you, and everyone breathes almost everything so sick, and people are still suffering from sickness and death .

About the author

Leave a Reply

Your email address will not be published. Required fields are marked *