omega-3 carboxylic acids

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

Indications ⬆ ⬇

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

Contraindications ⬆ ⬇

Hypersensitivity to any of the components of the product

Black Box Warnings ⬆ ⬇

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment

Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

Hepatic impairment: Dose adjustments not defined

Warnings/Precautions ⬆ ⬇

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/Breast Feeding ⬆ ⬇

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

Adverse Reactions ⬆ ⬇

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

Additional adverse reactions in patients with chronic gastrointestinal disease:

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

Clinical Pharmacology ⬆ ⬇

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)