Familial Hypertriglyceridemia Treatments

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Brand Name

Lovaza

Generic Name
Omega-3-Acid
View Brand Information
FDA approval date: April 07, 2014
Classification: Omega-3 Fatty Acid
Form: Capsule

What is Lovaza (Omega-3-Acid)?

Omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules and should continue this diet during treatment with omega-3-acid ethyl esters capsules. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules. 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 should be discontinued or changed, if possible, prior to consideration of TG-lowering drug therapy. Limitations of Use: The effect of omega-3-acid ethyl esters capsules on the risk for pancreatitis has not been determined. The effect of omega-3-acid ethyl esters capsules on cardiovascular mortality and morbidity has not been determined. Omega-3-acid ethyl esters capsules are a combination of ethyl esters of omega 3 fatty acids, principally eicosapentaenoic acid and docosahexaenoic acid , indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. Limitations of Use: The effect of omega-3-acid ethyl esters capsules on the risk for pancreatitis has not been determined. The effect of omega-3-acid ethyl esters capsules on cardiovascular mortality and morbidity has not been determined.
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Brand Information

Lovaza (OMEGA-3-ACID ETHYL ESTERS)
1INDICATIONS 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.
2DOSAGE 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
  • 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.
3DOSAGE 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".
4CONTRAINDICATIONS
LOVAZA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to LOVAZA or any of its components.
5DESCRIPTION
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 C
Chemical Structure
The empirical formula of DHA ethyl ester is C
Chemical Structure
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).
6HOW 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 80725-420-12.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
8PRINCIPAL DISPLAY PANEL - 1 gram Bottle Label
NDC 80725-420-12
Lovaza
1 gram*
Swallow capsules whole.
Rx only
120 Capsules
Waylis
PRINCIPAL DISPLAY PANEL - 1 gram Bottle Label