Label: LOVAZA- omega-3-acid ethyl esters capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 54868-5816-0, 54868-5816-1, 54868-5816-2, 54868-5816-3, view more54868-5816-4 - Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0173-0783
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated September 8, 2009
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use LOVAZA safely and effectively. See full prescribing information for LOVAZA. LOVAZA® (omega-3-acid ethyl esters) Capsules Initial U.S. Approval: 2004
INDICATIONS AND USAGE
LOVAZA is a combination of ethyl esters of omega 3 fatty acids, principally EPA and DHA, 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 LOVAZA on cardiovascular mortality and morbidity in patients with elevated triglycerides has not been determined. (1)
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
1-gram transparent soft-gelatin capsules. (3)
CONTRAINDICATIONS
LOVAZA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to LOVAZA or any of its components. (4)
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
The most common adverse reactions (incidence >3% and greater than placebo) were eructation, dyspepsia, and taste perversion. (6)
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
Omega-3-acids may prolong bleeding time. Patients taking LOVAZA and an anticoagulant or other drug affecting coagulation should be monitored periodically. (7.1)
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 2/2011
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Table of Contents
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
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Anticoagulants or Other Drugs Affecting Coagulation
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
9 DRUG ABUSE AND DEPENDENCE
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Severe Hypertriglyceridemia
14.2 Other Clinical Experience
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Information for Patients
17.2 FDA-Approved Patient Labeling
- *
- Sections or subsections omitted from the full prescribing information are not listed.
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1 INDICATIONS AND USAGE
LOVAZA® (omega-3-acid ethyl esters) 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 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 LOVAZA therapy. 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 cardiovascular mortality and morbidity in patients with elevated triglycerides has not been determined.
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2 DOSAGE AND ADMINISTRATION
- Assess triglyceride levels carefully 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 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.
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
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5 WARNINGS AND PRECAUTIONS
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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 LOVAZA. In some patients, increases in ALT levels without a concurrent increase in AST levels were observed.
In some patients, LOVAZA increases 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.
5.2 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.
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6 ADVERSE REACTIONS
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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 3% and at a greater rate than placebo for patients treated with LOVAZA based on pooled data across 23 clinical studies are listed in Table 1.
Table 1. Adverse Reactions Occurring at Incidence ≥3% and Greater than Placebo in Clinical Studies of LOVAZA BODY SYSTEM
Adverse Reaction*LOVAZA
(N = 655)Placebo
(N = 370)n % n % Eructation 29 4 5 1 Dyspepsia 22 3 6 2 Taste perversion 27 4 1 <1 * Studies included subjects with HTG and severe HTG.
Additional adverse reactions from clinical studies are listed below:
Digestive System: Constipation, gastrointestinal disorder and vomiting.
Metabolic and Nutritional Disorders: Increased ALT and increased AST.
Skin: Pruritus and rash.
6.2 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.
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7 DRUG INTERACTIONS
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7.1 Anticoagulants or Other Drugs Affecting Coagulation
Some studies with omega-3-acids demonstrated prolongation of bleeding time. The prolongation of bleeding time reported in these studies has not exceeded normal limits and did not produce clinically significant bleeding episodes. Clinical studies 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 should be monitored periodically (e.g., aspirin, NSAIDS, warfarin, coumarin).
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8 USE IN SPECIFIC POPULATIONS
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8.1 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 DataOmega-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/day based on a body surface area comparison.
In female rats given oral gavage doses of 100, 600, and 2,000 mg/kg/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/day based on body surface area comparison).
In pregnant rats given oral gavage doses of 1,000, 3,000, and 6,000 mg/kg/day from gestation day 6 through 15, no adverse effects were observed (14 times human systemic exposure following an oral dose of 4 grams/day based on a body surface area comparison).
In pregnant rats given oral gavage doses of 100, 600, and 2,000 mg/kg/day from gestation day 14 through lactation day 21, no adverse effects were seen at 2,000 mg/kg/day (5 times the human systemic exposure following an oral dose of 4 grams/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/kg/day (7 times the human systemic exposure following an oral dose of 4 grams/day based on a body surface area comparison).
In pregnant rabbits given oral gavage doses of 375, 750, and 1,500 mg/kg/day from gestation day 7 through 19, no findings were observed in the fetuses in groups given 375 mg/kg/day (2 times human systemic exposure following an oral dose of 4 grams/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/day based on a body surface area comparison).
- 9 DRUG ABUSE AND DEPENDENCE
- 10 OVERDOSAGE
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11 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).
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12 CLINICAL PHARMACOLOGY
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12.1 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.
12.3 Pharmacokinetics
In healthy volunteers and in patients 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 PopulationsAgeUptake of EPA and DHA into serum phospholipids in subjects treated with LOVAZA was independent of age (<49 years versus >49 years).
GenderFemales tended to have more uptake of EPA into serum phospholipids than males. The clinical significance of this is unknown.
PediatricPharmacokinetics of LOVAZA in pediatric patients have not been established [see Use in Specific Populations (8.4)].
Renal or Hepatic ImpairmentLOVAZA has not been studied in patients with renal or hepatic impairment.
Drug-Drug InteractionsSimvastatinIn a 14-day study of 24 healthy adult subjects, daily co-administration 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.
AtorvastatinIn a 14-day study of 50 healthy adult subjects, daily co-administration 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.
RosuvastatinIn a 14-day study of 48 healthy adult subjects, daily co-administration 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.
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13 NONCLINICAL TOXICOLOGY
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13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
In a rat carcinogenicity study with oral gavage doses of 100, 600, and 2,000 mg/kg/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/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/kg/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/kg/day (5 times human systemic exposure following an oral dose of 4 grams/day based on a body surface area comparison).
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14 CLINICAL STUDIES
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14.1 Severe Hypertriglyceridemia
The effects of LOVAZA 4 grams per day were assessed in 2 randomized, placebo-controlled, double-blind, parallel-group studies of 84 adult patients (42 on LOVAZA, 42 on placebo) with very high triglyceride levels. Patients whose baseline triglyceride levels were between 500 and 2,000 mg/dL were enrolled in these 2 studies of 6 and 16 weeks duration. The median triglyceride and LDL-C levels in these patients were 792 mg/dL and 100 mg/dL, respectively. Median HDL-C level was 23.0 mg/dL.
The changes in the major lipoprotein lipid parameters for the groups receiving LOVAZA or placebo are shown in Table 2.
Table 2. Median Baseline and Percent Change From Baseline in Lipid Parameters in Patients with Very High TG Levels (≥500 mg/dL) Parameter LOVAZA
N = 42Placebo
N = 42Difference BL % Change BL % Change TG 816 -44.9 788 +6.7 -51.6 Non-HDL-C 271 -13.8 292 -3.6 -10.2 TC 296 -9.7 314 -1.7 -8.0 VLDL-C 175 -41.7 175 -0.9 -40.8 HDL-C 22 +9.1 24 0.0 +9.1 LDL-C 89 +44.5 108 -4.8 +49.3 BL = Baseline (mg/dL); % Change = Median Percent Change from Baseline; Difference = LOVAZA Median % Change – Placebo Median % Change
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 in patients with very high TG levels has not been evaluated.
The effect of LOVAZA on cardiovascular mortality and morbidity in patients with elevated TG levels has not been determined.
14.2 Other Clinical Experience
The effects of LOVAZA 4 grams per day as add-on therapy to treatment with simvastatin were evaluated in a randomized, placebo-controlled, double-blind, parallel-group study of 254 adult patients (122 on LOVAZA and 132 on placebo) with persistent high triglycerides (200 to 499 mg/dL) despite simvastatin therapy. Patients were treated with open-label simvastatin 40 mg per day for 8 weeks prior to randomization to control their LDL-C to no greater than 10% above NCEP ATP III goal and remained on this dose throughout the study. Following 8 weeks of open-label treatment with simvastatin, patients were randomized to either LOVAZA 4 grams per day or placebo for an additional 8 weeks with simvastatin co-therapy. The median baseline triglyceride and LDL-C levels in these patients were 268 mg/dL and 89 mg/dL, respectively. Median baseline non-HDL-C and HDL-C levels were 138 mg/dL and 45 mg/dL, respectively.
The changes in the major lipoprotein lipid parameters for the groups receiving LOVAZA plus simvastatin or placebo plus simvastatin are shown in Table 3.
Table 3. Response to the Addition of LOVAZA 4 grams per day to Ongoing Simvastatin 40 mg per day Therapy in Patients with High Triglycerides (200 to 499 mg/dL) Parameter LOVAZA + Simvastatin
N = 122Placebo + Simvastatin
N = 132Difference P-Value BL EOT Median % Change BL EOT Median % Change Non-HDL-C 137 123 -9.0 141 134 -2.2 -6.8 <0.0001 TG 268 182 -29.5 271 260 -6.3 -23.2 <0.0001 TC 184 172 -4.8 184 178 -1.7 -3.1 <0.05 VLDL-C 52 37 -27.5 52 49 -7.2 -20.3 <0.05 Apo-B 86 80 -4.2 87 85 -1.9 -2.3 <0.05 HDL-C 46 48 +3.4 43 44 -1.2 +4.6 <0.05 LDL-C 91 88 +0.7 88 85 -2.8 +3.5 =0.05 BL = Baseline (mg/dL); EOT = End of Treatment (mg/dL); Median % Change = Median Percent Change from Baseline; Difference = LOVAZA Median % Change – Placebo Median % Change
LOVAZA 4 grams per day significantly reduced non-HDL-C, TG, TC, VLDL-C, and Apo-B levels and increased HDL-C and LDL-C from baseline relative to placebo.
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16 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 LOVAZA.
Bottles of 30
NDC 54868-5816-2
Bottles of 60
NDC 54868-5816-0
Bottles of 90
NDC 54868-5816-3
Bottles of 120
NDC 54868-5816-1
Bottles of 360
NDC 54868-5816-4
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Keep out of reach of children.
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17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (17.2).
17.1 Information for Patients
- LOVAZA should be used with caution in patients with known sensitivity or allergy to fish and/or shellfish [see Warnings and Precautions (5.3)].
- Patients should be advised that use of lipid-regulating agents does not reduce the importance of adhering to diet [see Dosage and Administration (2)].
- Patients should be advised not to alter LOVAZA capsules in any way and to ingest intact capsules only [see Dosage and Administration (2)].
17.2 FDA-Approved Patient Labeling
Patient labeling is provided as a tear-off leaflet at the end of this full prescribing information.
Manufactured for GlaxoSmithKline by:
Catalent Pharma Solutions
2725 Scherer Drive
St. Petersburg, FL 33716-1016
Accucaps Industries Limited
2125 Ambassador Drive
Windsor, Ontario, Canada N9B 3R5
Banner Pharmaceuticals Inc.
4125 Premier Drive
High Point, NC 27265
Distributed by:
GlaxoSmithKline
Research Triangle Park, NC 27709
LOVAZA is a registered trademark of the GlaxoSmithKline group of companies.
©2010 GlaxoSmithKline. All rights reserved.
December 2010
LVZ:6PI
Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146
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PATIENT PACKAGE INSERT
PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT
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PATIENT INFORMATION
LOVAZA® (lō-vā-ză)
(omega-3-acid ethyl esters) Capsules
Read the Patient Information that comes with LOVAZA before you start taking it, and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.
What is LOVAZA?
LOVAZA is a prescription medicine, called a lipid-regulating medicine, for adults. LOVAZA is made of omega-3 fatty acids from oils of fish, such as salmon and mackerel. Omega-3 fatty acids are substances that your body needs but cannot produce itself.
LOVAZA is used along with a low-fat and low-cholesterol diet to lower very high triglycerides (fats) in your blood. Before taking LOVAZA, talk to your healthcare provider about how you can lower high blood fats by:
- losing weight, if you are overweight
- increasing physical exercise
- lowering alcohol use
- treating diseases such as diabetes and low thyroid (hypothyroidism)
- adjusting the dose or changing other medicines that raise triglyceride levels such as certain blood pressure medicines and estrogens
Treatment with LOVAZA has not been shown to prevent heart attacks or strokes.LOVAZA has not been studied in children under the age of 18 years.
Who should not take LOVAZA?
Do not take LOVAZA if you:
- are allergic to LOVAZA or any of its ingredients. See the end of this leaflet for a complete list of ingredients in LOVAZA.
What should I tell my doctor before taking LOVAZA?Tell your doctor about all of your medical conditions, including if you:
- drink more than 2 glasses of alcohol daily.
- have diabetes.
- have a thyroid problem called hypothyroidism.
- have a liver problem.
- have a pancreas problem.
- are allergic to fish and/or shellfish. LOVAZA may not be right for you.
- are pregnant, or planning to become pregnant. It is not known if LOVAZA can harm your unborn baby.
- are breastfeeding. It is not known if LOVAZA passes into your milk and if it can harm your baby.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicine, vitamins, and herbal supplements. LOVAZA and certain other medicines can interact. Especially tell your doctor if you take medicines that affect clotting such as anticoagulants or blood thinners. Examples of these medicines include aspirin, nonsteroidal anti-inflammatory agents (NSAIDS), warfarin, coumarin, and clopidogrel (PLAVIX®).Know all the medicines you take. Keep a list of them with you to show your doctor and pharmacist.
How should I take LOVAZA?
- Take LOVAZA exactly as prescribed. Do not change your dose or stop LOVAZA without talking to your doctor.
- The usual dose of LOVAZA is 4 capsules:
- Take all 4 capsules at the same time, or
- Take 2 capsules two times a day
- Take LOVAZA at the same time or times each day.
- Take LOVAZA with or without food. You may find it easier to take LOVAZA with food.
- Do not take more than 4 capsules a day. Taking more than 4 capsules per day may increase the chance of side effects.
- Take LOVAZA capsules whole. Do not break, crush, dissolve, or chew LOVAZA capsules before swallowing. If you cannot swallow LOVAZA capsules whole, tell your doctor. You may need a different medicine.
- Your doctor should start you on a low-fat and low-cholesterol diet before giving you LOVAZA. Stay on this low-fat and low-cholesterol diet while taking LOVAZA.
- Your doctor should do blood tests to check your triglyceride and cholesterol levels during treatment with LOVAZA.
- If you have liver disease, your doctor should do blood tests to check your liver function during treatment with LOVAZA.
- If you miss a dose of LOVAZA, take it as soon as you remember. However, if you miss one day of LOVAZA, do not double your dose when you next take it.
- If you take too much LOVAZA or overdose, call your doctor or Poison Control Center right away.
What are the possible side effects of LOVAZA?The most common side effects with LOVAZA are burping, upset stomach, and a change in your sense of taste.
LOVAZA may affect certain blood tests. It may change:
- one of the tests to check liver function (ALT)
- one of the tests to measure cholesterol levels (LDL-C)
Talk to your doctor if you have side effects that bother you or that will not go away. You may report side effects to FDA at 1-800-FDA-1088.These are not all the side effects with LOVAZA. For more information, ask your doctor or pharmacist.
How should I store LOVAZA?
- Store LOVAZA at room temperature, 59° to 86° F (15° to 30° C). Do not freeze.
- Do not keep medicine that is out of date or that you no longer need.
- Keep LOVAZA out of the reach of children. Be sure that if you throw medicines away, it is out of the reach of children.
General information about LOVAZAMedicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. 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 problem you have. It may harm them.
This leaflet summarizes the most important information about LOVAZA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about LOVAZA that is written for health professionals or go to www.LOVAZA.com.
What are the ingredients in LOVAZA?Active Ingredient: Omega-3-acid ethyl esters
Inactive Ingredients: Gelatin, glycerol, purified water, alpha-tocopherol (in soybean oil)
LOVAZA is a registered trademark of the GlaxoSmithKline group of companies.
PLAVIX is a registered trademark of Sanofi-Synthelabo.
Manufactured for GlaxoSmithKline by:
Catalent Pharma Solutions
2725 Scherer Drive
St. Petersburg, FL 33716-1016
Accucaps Industries Limited
2125 Ambassador Drive
Windsor, Ontario, Canada N9B 3R5
Banner Pharmaceuticals Inc.
4125 Premier Drive
High Point, NC 27265
Distributed by:
GlaxoSmithKline
Research Triangle Park, NC 27709
©2010 GlaxoSmithKline. All rights reserved.
December 2010
LVZ:4PIL
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PRINCIPAL DISPLAY PANEL
Lovaza®
(omega-3-acid ethyl esters)
Capsules
Rx only
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) [see USP Controlled Room Temperature]. Do not freeze.
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INGREDIENTS AND APPEARANCE
LOVAZA
omega-3-acid ethyl esters capsule, liquid filledProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5816(NDC:0173-0783) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEGA-3-ACID ETHYL ESTERS (UNII: D87YGH4Z0Q) (OMEGA-3-ACID ETHYL ESTERS - UNII:D87YGH4Z0Q) OMEGA-3-ACID ETHYL ESTERS 1 g Inactive Ingredients Ingredient Name Strength ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Product Characteristics Color yellow (Light Yellow) Score no score Shape CAPSULE Size 24mm Flavor Imprint Code LOVAZA Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-5816-0 60 in 1 BOTTLE 2 NDC:54868-5816-1 120 in 1 BOTTLE 3 NDC:54868-5816-2 30 in 1 BOTTLE 4 NDC:54868-5816-3 90 in 1 BOTTLE 5 NDC:54868-5816-4 360 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021654 12/11/2008 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel, repack