Epanova Approval, Cost, Side Effects, Dosage, Drug Interactions | Steven Ma, PharmD Intern | RxEconsult

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Epanova (Omega-3-Carboxlic Acids) Approval, Side Effects, Dosing Category: Cholesterol by Steven Ma, PharmD Intern - May 28, 2014 | Views: 2740 | Likes: 3 | Comment: 0

Epanova | Omega-3-Carboxlic Acids Epanova for high tryglycerides

Medication Class: Anti-hyperlipidemic; Omega-3 Fatty Acid
Similar Drugs: Lovaza (Omega-3-Acid Ethyl Esters); Vascepa (icosapent ethyl)
Manufacturer: AstraZeneca
Approval Date: May 6, 2014

What is Epanova?

Epanova (Omega-3-Carboxylic Acids) is the first FDA approved omega-3 in free-fatty acid form used to treat high levels of triglycerides, which is fat in the body. It is made from fish oil and it is a mixture of docosahexanenoic acid (DHA), eicosapentaenoic acid (EPA), and other free fatty acids. Omega-3 fatty acids are a type of “good fat” that reduce triglycerides in the blood. When triglycerides are too high, they can increase the risk of heart disease and pancreatitis. According to the American Heart Association, triglyceride levels should be at or below 100 mg/dL. Currently, the exact mechanism of action of Epanova is unknown, but some possible mechanisms include increased plasma lipoprotein lipase activity, inhibition of acyl-CoA, and decreased liver lipogenelipogenesis. This means that Epanova decreases triglycerides by preventing the formation and release of triglycerides in the liver and to increase the clearance of triglycerides from the blood. 

What is Epanova indicated for?

Epanova is a prescription medication that should be used along with diet to help reduce triglyceride(TG) levels in adults with severe hypertriglyceridemia (>500 mg/dL). 

How effective is Epanova?

Epanova 2-gram, 3-gram, and 4-gram were compared to a placebo (olive oil) in a 12-week randomized trial in patients with triglyceride levels between 500 and 2000 mg/dL. The study showed a reduction in triglycerides of 10% for placebo, 25% for Epanova 2-gram, and 31% for Epanova 4-gram. The results from Epanova 3-gram did not show any meaningful difference from Epanova 2-gram and is therefore not described. Both Epanova 2-gram and 4-gram showed significant reductions in TG levels than placebo. Although Epanova showed significant reductions in triglyceride levels, there were also increases in LDL cholesterol levels (bad cholesterol). The study showed an increase of LDL-C  of 10% for placebo, 21% for Epanova 2-gram, and 26% for Epanova 4-gram. 

Epanova Versus Lovaza?

Epanova is in a free fatty acid form while Lovaza is in ethyl ester form. Epanova is formulated as a free fatty acid to increase its absorption into the blood.  

What are Epanova side effects?

Common: Diarrhea, nausea, abdominal pain or discomfort, belching  

Serious: May increase LDL cholesterol levels

Dosage?

Epanova is available as 1-gram capsules.  The dosage of Epanova should be 2-grams (2 capsules) or 4-grams (4 capsules) once daily.  This should be individualized for each patient depending on the patient's response and tolerability. 

What are possible drug interactions with Epanova?

Anti-platelet or anti-coagulation(e.g. aspirin, warfarin, clopidogrel):  Although there are no clinical studies of Epanova and drugs affecting coagulation (blood clotting), there is evidence that omega-3 fatty acids may prolong bleeding time. Patients taking any drugs that affect coagulation should be monitored periodically when treated with Epanova. 

What are Epanova Precautions?

  • Possible allergic reaction if you are allergic to fish or shellfish
  • May increase liver function (AST and ALT) test
  • May cause prolongation of bleeding time

What is the cost of Epanova?

According to the manufacturer the price of Epanova has not been established. There is currently no set date when Epanova will hit the market.    

How to obtain prescription assistance for Epanova?

Contact Astrazeneca via AZ&Me Prescription Savings Programs to obtain prescription savings information for Epanova. 

References

Epanova Prescribing Information (Package insert)

 

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