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Indication, Usage and Important Safety Information: LOVAZA™ (omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce very high (≥500 mg/dL) triglyceride (TG) levels in adult patients.

In individuals with hypertriglyceridemia (HTG), address excess body weight and alcohol intake before initiating any drug therapy. Diet and exercise can be important ancillary measures. Look for and treat diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus. Certain treatments (e.g., estrogen therapy, thiazide diuretics and beta blockers) are sometimes associated with very significant rises in serum triglyceride (TG) levels. Discontinuation of the specific agent may obviate the need for specific drug therapy for HTG.

Consider lipid-regulating agent use only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. Advise patients that lipid-regulating agent use does not reduce the importance of adhering to diet. (See PRECAUTIONS section of full prescribing information.)

In patients with very high TG levels the effect of LOVAZA on the risk of pancreatitis has not been evaluated, nor has its effect on cardiovascular mortality and morbidity been determined.

1. LOVAZA is contraindicated in patients who exhibit hypersensitivity to any component of this medication.
2. Before instituting LOVAZA therapy, it should be confirmed that TG levels are consistently abnormal.
3. LOVAZA should be used with caution in patients with known sensitivity or allergy to fish.
4. The patient’s TG, LDL-C and ALT levels should be monitored periodically during LOVAZA therapy. In some patients, LOVAZA increased LDL-C. LOVAZA therapy should be withdrawn in patients who do not have an adequate response after 2 months of treatment.
5. Some studies with omega-3-acids demonstrated prolongation of bleeding time, which did not exceed normal limits and did not produce clinically significant bleeding episodes. Patients receiving treatment with both LOVAZA and anticoagulants should be monitored periodically.
6. There are no adequate and well-controlled studies in pregnant women. Use LOVAZA during pregnancy only if the potential benefit justifies the potential risk to the fetus; and use with caution when administering LOVAZA to breastfeeding women.
7. LOVAZA was well-tolerated in controlled studies. The most common adverse events reported were: eructation, infection, flu syndrome, dyspepsia, rash, taste perversion, and back pain.
8. Please see full prescribing information.