Adult Dosing

Severe hypertriglyceridemia

• Dose: 2-4 g PO qd

Note:

• Dosage should be individualized according to the patient’s response and tolerability
• Advise patients to swallow the capsules whole without breaking, crushing, dissolving, or chewing

Pediatric Dosing

• Safety and efficacy in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• As an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (TG 500 mg/dL)

Note:

• Limitations of use:The effect of omega-3 carboxylic acids (Epanova) on the risk of pancreatitis in patients with severe hypertriglyceridemia has not been determined The effect of omega-3 carboxylic acids (Epanova) on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined

• Hypersensitivity to any of the components of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Omega-3-carboxylic acid may increase LDL-C levels. Monitor LDL-C levels periodically during therapy
• Monitor ALT and AST levels periodically during therapy in patients with hepatic impairment
• Use with caution in patients with known hypersensitivity to fish and/or shellfish

Pregnancy Category:C

Breastfeeding: Studies have demonstrated that omega-3 fatty acids derived from fish oil get excreted in human milk at levels higher than that in plasma. However, effect of this excretion on infants is unknown; manufacturer advises caution

• GI: Diarrhea, nausea, abdominal pain or discomfort, eructation

• GI: Abdominal distension, constipation, vomiting
• CNS: Dysguesia
• EENT: Nasopharyngitis
• MUSC: Arthralgia
• MISC: Fatigue

• Lipid-regulating agent; exact mechanism of action is unknown. However, potential mechanisms of action include inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase, increased mitochondrial and peroxisomal -oxidation in the liver, decreased lipogenesis in the liver, and increased plasma lipoprotein lipase activity Omega-3 carboxylics acids may reduce the synthesis of triglycerides in the liver because eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are poor substrates for the enzymes involved in TG synthesis and EPA and DHA inhibit esterification of other fatty acids
• Metabolism: Metabolized in the liver
• Excretion: Does not undergo renal excretion
• Half-life: 37 hrs (EPA) and 46 hrs (DHA)

US Trade Name(s)

• Epanova

US Availability

Epanova

• Softgel CAPS: 1 g

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Cardiovascular

Lipid Lowering Agent

Fatty Acids