Epanova

Generic Name: omega-3-carboxylic acids
Date of Approval: May 5, 2014
Company: AstraZeneca

Treatment for: Hypertriglyceridemia

FDA Approves Epanova

The United States Food and Drug Administration (FDA) has approved AstraZeneca’s Epanova (omega-3-carboxylic acids) in conjunction with diet to treat severe hypertriglyceridemia in adults. Hypertriglyceridemia condition characterized by high levels of triglycerides in the blood, and while an essential energy source for the body, high triglyceride levels can lead to serious health complications. Hypertriglyceridemia is considered severe when triglyceride levels are greater than or equal to 500 mg/dL.

Epanova is the first FDA approved prescription omega-3 in free fatty acid form. It is derived from fish oil and consists of an ultra-pure mixture of the free fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). Similar prescription drugs used in the treatment of hypertriglyceridemia include Lovaza (omega-3-acid ethyl esters) and Vascepa (icosapent ethyl). Generic versions of Lovaza were approved in April 2013.

The FDA approval was based on data from a that included positive results from the Phase III EVOLVE (EpanoVa fOr Lowering Very High triglyceridEs) trial. AstraZeneca is continuing to evaluate the clinical profile of Epanova through a large-scale cardiovascular outcomes trial, STRENGTH (STatin Residual risk reduction with EpaNova in hiGh cardiovascular risk paTients with Hypertriglyceridemia) in combination with statin therapy. The company's statin product Crestor (rosuvastatin) holds a large market share and may be developed further as a fixed dose combination with Epanova.

The dosage of Epanova is 2 grams (2 capsules) or 4 grams (4 capsules), making it the first prescription omega-3 to have a dosing option as few as two capsules once a day, with or without food.

Epanova Patient Information

Read this Patient Information before you receive this medicine and each time you receive treatment. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

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What is Epanova?

Epanova 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 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.

Who should not take Epanova?

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
  • 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.

How should I take Epanova?

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.

Epanova side effects

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

The most common side effects include:

  • diarrhea
  • upset stomach
  • abdominal pain or discomfort
  • burping

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 FDA at 1-800-FDA-1088.

Storage and Handling

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

General information about the safe and effective use of Epanova

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.

Ingredients

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)

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