Icosapent

1-10%

Arthralgia (2.3%)

Frequency Not Defined

Oropharyngeal pain

Mechanism of Action

Ethyl ester of eicosapentaenoic acid (EPA); EPA has been shown to reduce hepatic very low-density lipoprotein triglycerides (VLDL-TG) synthesis and/or secretion; enhances triglyceride clearance from circulating VLDL particle; may also increase beta-oxidation, inhibits acyl-CoA:1,2-diacylglycerol acyltransferase (DGAT), decrease lipogenesis in liver, and increase plasma lipoprotein lipase activity

Absorption

De-esterified during absorption to active EPA that is absorbed in small intestine

Peak Plasma Time: 5 hr

Distribution

Protein Bound: >99% of unesterified EPA

Vd: 88 L

Metabolism

Mainly metabolized by the liver via beta-oxidation similar to dietary fatty acids; minor CYP450 mediated metabolism

Elimination

Half-life: 89 hr

Does not undergo renal excretion

Total plasma clearance: 684 mL/hr

Common Side Effects of Vascepa

Tell your doctor if any of the following side effects become severe or don't go away:

• Sore throat
• Joint pain

Serious Side Effects of Vascepa

Tell your doctor right away if you experience any of the following serious side effects:

• Signs of anaphylaxis, which may include rash, hives, itching, difficulty breathing, chest tightness, or swelling of the face, mouth, lips, or tongue

Icosapent works in the liver and bloodstream to reduce very low-density triglycerides.

Icosapent is used together with a low-fat and low-cholesterol diet to reduce triglycerides (fats) in adults with severely high triglycerides.

It is not known whether icosapent will lower your risk of developing heart disease or pancreatitis (inflammation of your pancreas).

Icosapent may also be used for purposes not listed in this medication guide.

You should not use icosapent if you are allergic to it.

To make sure icosapent is safe for you, tell your doctor if you have:

• liver disease;

• diabetes;

• a thyroid disorder;

• problems with your pancreas;

• a bleeding or blood-clotting disorder;

• if you are allergic to fish or shellfish; or

• if you drink large amounts of alcohol.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Icosapent can pass into breast milk, but effects on the nursing baby are not known. Tell your doctor if you are breast-feeding.

Icosapent is not approved for use by anyone younger than 18 years old.

Data not available

Data not available

Icosapent has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of decreased fetal survival, teratogenicity (visceral or skeletal abnormalities, absence of optic nerve, and testes atrophy), and female fertility impairment (decreased copulation rate, delayed estrus, and decreased implantations). There are no controlled data in human pregnancy. The manufacturer recommends that icosapent should only be used during pregnancy when the potential benefits outweigh the potential risks to the developing fetus.