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 certainblood 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.
Why is LOVAZA® only available with a prescription?
- LOVAZA® is different from dietary supplements. Supplements are not FDA-approved to treat a specific disease like very high triglycerides†.
- LOVAZA® is potent. The FDA-approved dose of LOVAZA® is 4 capsules (4 grams) per day. It could take up to 14 capsules per day of an OTC omega-3 supplement to provide the same amount of active ingredients in LOVAZA®.
- LOVAZA® goes through an FDA-approved 5-step process to create a highly purified omega-3 medication.
- Each 1-gram capsule of LOVAZA® contains 465 mg EPA and 375 mg DHA. EPA and DHA are the active fatty acids proven to lower very high triglycerides†.
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 leaflet 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.
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)
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.
What are the ingredients in LOVAZA®?
Active Ingredient: Omega-3-acid ethyl esters
Inactive Ingredients: Gelatin, glycerol, purified water, alpha-tocopherol (in soybean oil)
For more information about LOVAZA®, please click here to see the full Prescribing Information.