Risks and side effects

What is LOVAZA?

LOVAZA is a prescription medicine, called a lipid-regulating medicine, for adults. LOVAZA is made of omega-3 fatty acids from oils of fish, such as salmon and mackerel. Omega-3 fatty acids are substances that your body needs but cannot produce itself.

LOVAZA is used along with a low-fat and low-cholesterol diet to lower very high triglycerides (fats) in your blood. Before taking LOVAZA, talk to your healthcare provider about how you can lower high blood fats by:

• Losing weight, if you are overweight
• Increasing physical exercise
• lowering alcohol use
• treating diseases such as diabetes and low thyroid (hypothyroidism)
• adjusting the dose or changing other medicines that raise triglyceride levels such as certain blood pressure medicines and estrogens

Treatment with LOVAZA has not been shown to prevent heart attacks or strokes.

LOVAZA has not been studied in children under the age of 18 years.

Who should not take LOVAZA?

Do not take LOVAZA if you:

• are allergic to LOVAZA or any of its ingredients. See the end of this page for a complete list of ingredients in LOVAZA.

What Should I Tell My Doctor Before Taking LOVAZA?

Tell your doctor about all of your medical conditions, including if you:

• drink more than 2 glasses of alcohol daily.
• have diabetes.
• have a thyroid problem called hypothyroidism.
• have a liver problem.
• have a pancreas problem.
• are allergic to fish and/or shellfish. LOVAZA may not be right for you
• are pregnant, or planning to become pregnant. It is not known if LOVAZA can harm your unborn baby.
• are breastfeeding. It is not known if LOVAZA passes into your milk and if it can harm your baby.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicine, vitamins, and herbal supplements. LOVAZA and certain other medicines can interact. Especially tell your doctor if you take medicines that affect clotting such as anticoagulants or blood thinners. Examples of these medicines include aspirin, nonsteroidal anti-inflammatory agents (NSAIDS), warfarin, coumarin, and clopidogrel (PLAVIX^®).

Know all the medicines you take. Keep a list of them with you to show your doctor and pharmacist.

How should I take LOVAZA?

• Take LOVAZA exactly as prescribed. Do not change your dose or stop LOVAZA without talking to your doctor.
• The usual dose of LOVAZA is 4 capsules:
• Take all 4 capsules at the same time, or
• Take 2 capsules two times a day
• Take LOVAZA at the same time or times each day.
• Take LOVAZA with or without food. You may find it easier to take LOVAZA with food.
• Do not take more than 4 capsules a day. Taking more than 4 capsules per day may increase the chance of side effects.
• Take LOVAZA capsules whole. Do not break, crush, dissolve, or chew LOVAZA capsules before swallowing. If you cannot swallow LOVAZA capsules whole, tell your doctor. You may need a different medicine.
• Your doctor should start you on a low-fat and low-cholesterol diet before giving you LOVAZA. Stay on this low-fat and low-cholesterol diet while taking LOVAZA.
• Your doctor should do blood tests to check your triglyceride and cholesterol levels during treatment with LOVAZA.
• If you have liver disease, your doctor should do blood tests to check your liver function during treatment with LOVAZA.
• If you miss a dose of LOVAZA, take it as soon as you remember. However, if you miss one day of LOVAZA, do not double your dose when you next take it.
• If you take too much LOVAZA or overdose, call your doctor or Poison Control Center right away.

What Are the Possible Side Effects of LOVAZA?

The most common side effects with LOVAZA are burping, infection, flu symptoms, upset stomach, a change in your sense of taste, back pain, and skin rash.
LOVAZA may affect certain blood tests. It may change:

• one of the tests to check liver function (ALT)
• one of the tests to measure cholesterol levels (LDL-C). In some patients, LDL (bad) cholesterol may increase.

Talk to your doctor if you have side effects that bother you or that will not go away. You may report side effects to FDA at 1-800-FDA-1088.

These are not all the side effects with LOVAZA. For more information, ask your doctor or pharmacist.

How should I store LOVAZA?

• Store LOVAZA at room temperature, 59° to 86° F (15° to 30° C). Do not freeze.
• Do not keep medicine that is out of date or that you no longer need.
• Keep LOVAZA out of the reach of children. Be sure that if you throw medicines away, it is out of the reach of children.

General information about LOVAZA

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. 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 problem you have. It may harm them.

This page summarizes the most important information about LOVAZA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about LOVAZA that is written for health professionals.

What are the ingredients in LOVAZA?

Active Ingredient: Omega-3-acid ethyl esters
Inactive Ingredients: Gelatin, glycerol, purified water, alpha-tocopherol (in soybean oil)

 

Important Safety Information for LOVAZA^® (omega-3-acid ethyl esters)

LOVAZA, along with diet, helps to lower very high triglycerides (≥500 mg/dL) in adult patients.

Tell your doctor if you are allergic to fish or shellfish as LOVAZA may not be right for you.

Talk to your doctor about any medical conditions you have and any medications you are taking, especially those that may increase your risk of bleeding. In some patients, LDL (bad) cholesterol may increase. Your healthcare provider should do blood tests before and during treatment with LOVAZA to check your cholesterol and
triglyceride levels. If you have liver disease, you may require additional monitoring.

Possible side effects include burping, infection, flu-like symptoms, upset stomach and change in sense of taste.

How supplied: 1-gram capsule

For more information about LOVAZA, please click here to see Patient Information or full Prescribing Information.