Lovaza Information
Lovaza () 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.
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.
Lovaza () Dosage And Administration
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 () .
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 Lovaza () .
Lovaza () Contraindications
Lovaza () is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Lovaza () or any of its components.
Lovaza () Warnings And Precautions
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 () .
Lovaza () Adverse Reactions
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 events reported in at least 1% of patients treated with Lovaza () 4 grams per day or placebo during 8 randomized, placebo-controlled, double-blind, parallel-group studies for HTG are listed in Table 1. Adverse events led to discontinuation of treatment in 3.5% of patients treated with Lovaza () and 2.6% of patients treated with placebo.
*
Additional adverse events reported by 1 or more patients from clinical studies for HTG are listed below:
Body as a Whole:
Cardiovascular System:
Digestive System:
Hematologic-Lymphatic System:
Infections and Infestations:
Metabolic and Nutritional Disorders:
Musculoskeletal System:
Nervous System:
Respiratory System:
Skin:
Special Senses:
Urogenital System:
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.
Lovaza () Drug Abuse And Dependence
Lovaza () does not have any known drug abuse or withdrawal effects.
Lovaza () Overdosage
In the event of an overdose, the patient should be treated symptomatically, and general supportive care measures instituted, as required.
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 CHO, 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 CHO, 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 Studies
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.
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.
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.
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.
Lovaza () 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 120: NDC 21695-795-72
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.
Lovaza () Patient Counseling Information
See FDA-approved patient labeling
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.
©2009 GlaxoSmithKline. All rights reserved.
September 2009 LVZ:5PI
PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT
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Lovaza ()
Lovaza ()
