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  • Lovaza
    (Omega-3-Acid Ethyl Esters) - GlaxoSmithKline

    THERAPEUTIC CLASS

    Lipid-regulating agent

    DEA CLASS

    RX

    INDICATIONS

    Adjunct to diet to reduce TG levels in adults with severe (≥500mg/dL) hypertriglyceridemia.

    ADULT DOSAGE

    Adults: 4g/day (4 caps qd or 2 caps bid).

    HOW SUPPLIED

    Cap: 1g

    WARNINGS/PRECAUTIONS

    Increases in ALT levels without a concurrent increase in AST levels reported. May increase LDL levels; monitor LDL levels periodically during therapy. Contains ethyl esters of omega-3 fatty acids (eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA]), obtained from oil of several fish sources; caution with known hypersensitivity to fish and/or shellfish. Recurrent symptomatic atrial fibrillation/flutter (A-fib/flutter) reported in patients with paroxysmal or persistent A-fib, particularly within the first 2-3 months of initiating therapy. Assess TG levels carefully before initiating therapy and monitor TG levels periodically during therapy.

    ADVERSE REACTIONS

    Eructation, taste perversion, dyspepsia.

    DRUG INTERACTIONS

    Periodically monitor patients receiving concomitant treatment with an anticoagulant or other drugs affecting coagulation (eg, antiplatelet agents). D/C or change medications known to exacerbate hypertriglyceridemia (eg, β-blockers, thiazides, estrogens), if possible, prior to consideration of therapy.

    PREGNANCY

    Category C, caution in nursing.

    MECHANISM OF ACTION

    Lipid-regulating agent; not established. 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. May reduce the synthesis of TGs 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.

    PHARMACOKINETICS

    Distribution: Found in breast milk.

    ASSESSMENT

    Assess for hypersensitivity to drug, fish and/or shellfish; hepatic impairment; A-fib/flutter; pregnancy/nursing status; and possible drug interactions. Attempt to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems that are contributing to lipid abnormalities (eg, diabetes mellitus, hypothyroidism). Assess TG and LDL levels.

    MONITORING

    Monitor for recurrent symptomatic A-fib/flutter in patients with paroxysmal or persistent A-fib. Monitor for allergic reactions and other adverse reactions. Periodically monitor ALT and AST levels in patients with hepatic impairment. Periodically monitor LDL and TG levels.

    PATIENT COUNSELING

    Instruct to notify physician if allergic to fish and/or shellfish. Advise that the use of lipid-regulating agents does not reduce the importance of adhering to diet. Advise not to alter caps in any way and to ingest intact caps only. Instruct to take as prescribed.

    ADMINISTRATION/STORAGE

    Administration: Oral route. Swallow caps whole; do not break open, crush, dissolve, or chew. Storage: 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Do not freeze.