Epanova

Epanova was 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 it changes your risk of having inflammation of your pancreas (pancreatitis).
• It is not known if it prevents you from having a heart attack or stroke.
• It is not known if it is safe and effective in children.

Epanova has been discontinued, and there is no generic omega-3-carboxylic acids available. Omega-3-carboxylic acids (Epanova) and omega-3-acid ethyl esters (Lovaza and generics) are not the same medicine, even though both supply the omega-3 fatty acids EPA and DHA.

• In Epanova, these fatty acids are present in their free form, as carboxylic acids, so they can be absorbed directly.
• In the ethyl ester products, the same fatty acids are attached to ethanol, and that bond has to be broken by pancreatic lipases in the gut before absorption can happen. Because of this, absorption of the ethyl ester products depends more on the fat content of the meal they are taken with.
• Epanova is no longer available in the US. AstraZeneca stopped the STRENGTH cardiovascular outcomes trial in January 2020 after an interim analysis found the trial was unlikely to show a benefit, and Epanova was discontinued. Epanova was not withdrawn because of a safety problem, although STRENGTH did report a higher rate of atrial fibrillation in the treatment group (2.2%) than in the corn oil comparator group (1.3%). There is no generic version.
• Omega-3-acid ethyl esters remain on the market.

The usual dosage is 2 grams (2 capsules) or 4 grams (4 capsules) once daily without regard to meals.

You should take the exact dose your doctor prescribes.

Do not change your dose or stop treatment without talking to your doctor.

If you miss a dose, take it as soon as you remember. However, if you miss one whole day of dosing, do not double your catch up dose.

Swallow capsules whole. Do not break open, crush, dissolve, or chew capsules before swallowing. If you cannot swallow the capsules whole, tell your doctor. You may need a different medicine.

Your doctor should start you on a diet that is low in saturated fat, cholesterol, carbohydrates, and low in added sugars. You should start this diet before your treatment, and continue during your treatment.

Your doctor should do blood tests to check your triglycerides, bad cholesterol and liver function levels during your treatment.

You should not take this medicine if you are allergic to omega-3-carboxylic acids or any of the other ingredients.

Before taking Epanova, tell your doctor about all 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
• are pregnant or plan to become pregnant, as it is not known if Epanova will harm your unborn baby
• are breastfeeding or plan to breastfeed, as Epanova can pass into your breast milk.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take medicines that affect blood clotting (anticoagulants or blood thinners).

Epanova may cause serious side effects, including:

• increases in the results of blood tests used to check your liver function (ALT and AST) and your bad cholesterol levels (LDL-C)
• possible allergic reactions if you are also allergic to fish or shellfish
• increased risk of a heart rhythm problem (atrial fibrillation or flutter) in people who already have a heart rhythm problem

The most common side effects include:

• diarrhea
• upset stomach
• abdominal pain or discomfort
• burping
• a change in your sense of taste
• vomiting.

This is not a complete list of possible side effects. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Epanova is a red/brown, soft gelatin capsule with the imprint OME1.

• Store Epanova at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not freeze.
• Keep all medicines out of the reach of children.

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

Active Ingredient: omega-3-carboxylic acids

Inactive Ingredients: α-tocopherol (in a carrier of vegetable oil), gelatin, glycerol, sorbitol, and purified water (components of the capsule shell). Coating and ink components to the capsules also contain ethyl acrylate and methyl methacrylate copolymer dispersion, talc, titanium dioxide, iron oxide red, polysorbate 80, and carboxymethylcellulose sodium (coating components), pharmaceutical glaze, titanium dioxide, n-butyl alcohol, propylene glycol and isopropanol (ink components)