scular mortality and morbidity in patients with elevated TG levels has not been determined.
INDICATIONS AND USAGE
Very High Triglycerides
LOVAZA is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with very high (≥500 mg/dL) triglyceride levels.
Usage Considerations
In individuals with hypertriglyceridemia (HTG), excess body weight and excess alcohol intake may be important contributing factors and should be addressed before initiating any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, (such as hypothyroidism or diabetes mellitus) should be looked for and adequately treated. Estrogen therapy, thiazide diuretics, and beta blockers are sometimes associated with massive rises in plasma TG levels. In such cases, discontinuation of the specific etiologic agent, if medically indicated, may obviate the need for specific drug therapy for HTG.
The use of lipid-regulating agents should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use lipid-regulating agents, the patient should be advised that use of lipid-regulating agents does not reduce the importance of adhering to diet (see PRECAUTIONS).
CONTRAINDICATIONS
LOVAZA is contraindicated in patients who exhibit hypersensitivity (e.g., anaphylactic reaction) to any component of this medication.
PRECAUTIONS
General
Initial Therapy
Laboratory studies should be performed to ascertain that the patient’s TG levels are consistently abnormal before instituting therapy with LOVAZA. Every attempt should be made to control serum TG levels with appropriate diet, exercise, weight loss in overweight patients, and control of any medical problems (such as diabetes mellitus and hypothyroidism) that may be contributing to the patient’s TG abnormalities. Medications known to exacerbate HTG (such as beta blockers, thiazides, and estrogens) should be discontinued or changed, if possible, before considering TG–lowering drug therapy.
Continued Therapy
Laboratory studies should be performed periodically to measure the patient’s TG levels during therapy with LOVAZA. Therapy with LOVAZA should be withdrawn in patients who do not have an adequate response after 2 months of treatment.
Information for Patients
LOVAZA should be used with caution in patients with known sensitivity or allergy to fish.
Patients should be advised that use of lipid-regulating agents does not reduce the importance of adhering to diet.
Laboratory Tests
In some patients, increases in alanine aminotransferase (ALT) levels without a concurrent increase in aspartate aminotransferase (AST) levels were observed. Alanine aminotransferase levels should be monitored periodically during therapy with LOVAZA.
In some patients, LOVAZA increased low-density lipoprotein cholesterol (LDL-C) levels. As with any lipid-regulating product, LDL-C levels should be monitored periodically during therapy with LOVAZA.
Drug Interactions
Anticoagulants
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 concomit |
