Lovaza 1 g/1

OMEGA-3-ACID ETHYL ESTERS · CAPSULE · Waylis Therapeutics LLC

No Recall History

Plain English

Lovaza is a capsule containing omega-3-acid ethyl esters at 1 g/1, taken oral. Manufactured by Waylis Therapeutics LLC.

Key Facts

Brand Name: Lovaza
Generic Name: OMEGA-3-ACID ETHYL ESTERS
NDC Code (Product): 80725-420
Manufacturer: Waylis Therapeutics LLC
Strength: 1 g/1
Dosage Form: CAPSULE
Route: ORAL
Marketing Status
Application #: NDA021654
Marketing Start: 01/15/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

flushing1,031 reports

nausea847 reports

drug ineffective770 reports

fatigue765 reports

diarrhoea738 reports

headache647 reports

pruritus646 reports

pain621 reports

dizziness613 reports

dyspnoea547 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 (greater than or equal to 500 mg/dL) hypertriglyceridemia. LOVAZA is a combination of ethyl esters of omega 3 fatty acids, principally eicosapentaenoic acid (EPA) and docosahexaenoic acid (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 the risk for pancreatitis has not been determined. ( 1 ) The effect of LOVAZA on cardiovascular mortality and morbidity has not been determined. ( 1 ) 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 c…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Assess TG levels carefully before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, medications) of high TG 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. 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). ( 2 ) Patients should be advised to swallow LOVAZA capsules whole. Do not break open, crush, dissolve, or chew LOVAZA. ( 2 )

Contraindications

4 CONTRAINDICATIONS LOVAZA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to LOVAZA or any of its components. LOVAZA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to LOVAZA or any of its components. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Omega-3-acids may prolong bleeding time. Patients taking LOVAZA and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents) should be monitored periodically. ( 7.1 ) 7.1 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.

Adverse Reactions

6 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 Waylis Therapeutics LLC at 1-844-200-7910 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 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 Adverse Reaction Trials included subjects with hypertriglyceridemia and severe hypertriglyceridemia. LOVAZA (n = 655) Placebo (n = 370) n % n % Eructation 29 4 5 1 Dyspepsia 22 3 6 2 Taste perversion 27 4 1 <1 Additional adverse reactions from clinical trials are listed below: Digestive System Constipation, gastrointestinal …

Frequently Asked Questions

What is Lovaza used for?

Lovaza contains OMEGA-3-ACID ETHYL ESTERS. It is a capsule taken oral. Consult your doctor for specific uses.

Is Lovaza a controlled substance?

Lovaza is not classified as a controlled substance by the DEA.

What is the generic name for Lovaza?

The generic name for Lovaza is OMEGA-3-ACID ETHYL ESTERS. There are 11 other brand versions of OMEGA-3-ACID ETHYL ESTERS.

What is the NDC code for Lovaza 1 g/1?

The NDC (National Drug Code) for Lovaza 1 g/1 is 80725-420, listed by Waylis Therapeutics LLC.

Product NDC

80725-420

Package NDC

80725-420-12

Other Omega-3-acid Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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