Lovaza

What is Lovaza?

Lovaza is a prescription medicine used along with a low-fat and low-cholesterol diet to lower very high triglyceride (fat) levels in adults. It is not known if Lovaza changes your risk of having inflammation of your pancreas (pancreatitis).

It is not known if Lovaza prevents you from having a heart attack or stroke. It is not known if Lovaza is safe and effective in children.

Description

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 C22H34O2, and the molecular weight of EPA ethyl ester is 330.51. The structural formula of EPA ethyl ester is:

The empirical formula of DHA ethyl ester is C24H36O2, and the molecular weight of DHA ethyl ester is 356.55. The structural formula of DHA ethyl ester is:

LOVAZA capsules also contain the following inactive ingredients: alpha-tocopherol, gelatin, glycerin and purified water (components of the capsule shell).

Mechanism of Action

The mechanism of action of LOVAZA is not completely understood. 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. LOVAZA may reduce the synthesis of TG 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.

Who should not take Lovaza?

Do not take Lovaza if you are allergic to omega-3-acid ethyl esters or any of the ingredients in Lovaza. See the end of this leaflet for a complete list of ingredients in Lovaza.

What should I tell my healthcare provider before taking Lovaza?

Before taking Lovaza, tell your healthcare provider about all of your medical conditions, including if you:

• have diabetes.
• have a low thyroid problem (hypothyroidism).
• have a liver problem.
• have a pancreas problem.
• have a certain heart rhythm problem called atrial fibrillation or flutter.
• are allergic to fish or shellfish. It is not known if people who are allergic to fish or shellfish are also allergic to Lovaza.
• are pregnant or plan to become pregnant. It is not known if Lovaza will harm your unborn baby.
• are breastfeeding or plan to breastfeed. Lovaza can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Lovaza.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Lovaza can interact with certain other medicines that you are taking. Using Lovaza with medicines that affect blood clotting (anticoagulants or blood thinners) may cause serious side effects.

How should I take Lovaza?

• Take Lovaza exactly as your healthcare provider tells you to take it.
• You should not take more than 4 capsules of Lovaza each day. Either take all 4 capsules at one time or 2 capsules two times a day.
• Do not change your dose or stop Lovaza without talking to your healthcare provider.
• Take Lovaza with food.
• Take Lovaza capsules whole. Do not break, open, crush, dissolve, or chew Lovaza capsules before swallowing. If you cannot swallow Lovaza capsules whole, tell your healthcare provider. You may need a different medicine.
• If you miss a dose of Lovaza, take the missed dose as soon as you remember. If you miss one day of Lovaza, do not double your dose the next time you take it.
• Your healthcare provider may start you on a cholesterol-lowering diet before giving you Lovaza. Stay on this diet while taking Lovaza.
• Your healthcare provider should do blood tests to check your triglyceride, bad cholesterol (LDL-C), and liver function (ALT and AST) levels while you take Lovaza.

What are the possible side effects of Lovaza?

Lovaza may cause serious side effects, including:

• changes in certain blood tests. Lovaza may cause an increase in the results of blood tests used to check your liver function and your bad cholesterol levels.
• increased risk of a heart rhythm problem in people who have a heart rhythm problem. Lovaza may cause an increase in the frequency of a heart rhythm problem (atrial fibrillation or flutter), especially in the first few months of taking Lovaza, if you already have a heart rhythm problem.

The most common side effects of Lovaza include:

• burping
• nausea
• upset stomach
• a change in your sense of taste

These are not all the possible side effects of Lovaza.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Lovaza.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Lovaza for a condition for which it was not prescribed. Do not give Lovaza to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about Lovaza that is written for health professionals.

How should I store Lovaza?

• Store Lovaza at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not freeze Lovaza.
• Safely throw away medicine that is out of date or no longer needed.

Keep Lovaza and all medicines out of the reach of children.

What are the ingredients in Lovaza?

Active Ingredient: omega-3-acid ethyl esters, mostly EPA and DHA

Inactive Ingredients: alpha-tocopherol (in soybean oil), gelatin, glycerol, purified water.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 

SRC: NLM .