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Omega-3 Fatty Acids

Pronunciation

(oh MEG a three FAT tee AS ids)

Index Terms

  • AMR101
  • Docosahexaenoic Acid
  • Eicosapentaenoic Acid
  • Epanova
  • Ethyl Eicosapentaenoate
  • Ethyl Esters of Omega-3 Fatty Acids
  • Ethyl Icosapentate
  • Ethyl-Eicosapentaenoic Acid
  • Ethyl-EPA
  • Fish Oil
  • Icosapent Ethyl
  • Omega 3
  • Omega-3-Acid Ethyl Esters
  • Omtryg
  • P-OM3

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Dialyvite Omega-3 Concentrate: 600 mg

Expecta LIPIL: 200 mg [DSC]

Fish Oil Ultra: 1000 mg [DSC]

Lovaza: 1 g [contains soybean oil, tocopherol, dl-alpha]

Ocean Blue MiniCaps Omega-3: 350 mg [gluten free, lactose free, sugar free; contains fd&c red #40, fd&c yellow #10 (quinoline yellow)]

Omega Power: 1050 mg [gluten free, lactose free, sugar free; contains fd&c red #40, fd&c yellow #10 (quinoline yellow); vanilla flavor]

Omega-3 2100: 1050 mg [odorless; orange flavor]

Vascepa: 0.5 g, 1 g

Generic: 300 mg, 500 mg, 1000 mg, 1 g

Capsule, Oral [preservative free]:

High Potency Fish Oil: 500 mg [DSC] [dairy free, gluten free, lactose free, milk derivatives/products, no artificial color(s), no artificial flavor(s), soy free, sugar free, wheat free, yeast free]

Maximum Red Krill: 300 mg [gluten free; contains soybean oil]

Omega-3 Fish Oil Ex St: 880 mg [gluten free]

Salmon Oil-1000: 200 mg [corn free, rye free, starch free, sugar free, wheat free]

Sam-E.P.A.: 200-300 MG [dye free]

Sea-Omega: 1000 mg [cholesterol free, corn free, gluten free, milk derivatives/products, no artificial color(s), no artificial flavor(s), sodium free, starch free, sugar free, yeast free; contains soybeans (glycine max)]

Generic: 200 mg, 1000 mg, 1200 mg

Capsule Delayed Release, Oral:

Pro Nutrients Omega 3: 332.5 mg

Systane Omega-3 Healthy Tears: 500 mg [DSC] [contains soybean oil]

Generic: 1000 mg

Tablet Chewable, Oral:

Omega-3 IQ: 240 mg [fruit flavor]

Brand Names: U.S.

  • Dialyvite Omega-3 Concentrate [OTC]
  • Expecta LIPIL [OTC] [DSC]
  • Fish Oil Ultra [OTC] [DSC]
  • High Potency Fish Oil [OTC] [DSC]
  • Lovaza
  • Maximum Red Krill [OTC]
  • Ocean Blue MiniCaps Omega-3 [OTC]
  • Omega Power [OTC]
  • Omega-3 2100 [OTC]
  • Omega-3 Fish Oil Ex St [OTC]
  • Omega-3 IQ [OTC]
  • Pro Nutrients Omega 3 [OTC]
  • Salmon Oil-1000 [OTC]
  • Sam-E.P.A. [OTC]
  • Sea-Omega [OTC]
  • Systane Omega-3 Healthy Tears [OTC] [DSC]
  • Vascepa

Pharmacologic Category

  • Antilipemic Agent, Omega-3 Fatty Acids

Pharmacology

Reduction in the hepatic production of triglyceride-rich very low-density lipoproteins (VLDL). Possible cellular mechanisms include inhibition of acyl CoA:1,2 diacylglycerol acyltransferase, increased hepatic mitochondrial and peroxisomal beta-oxidation, and a reduction in the hepatic synthesis of triglycerides.

Absorption

Omega-3-carboxylic acids: Directly absorbed in the small intestine. Administration with a high-fat meal results in an increased overall exposure of total and free baseline-adjusted EPA by ~140% and 80%, respectively, compared to fasting conditions; a 40% increase in AUC occurred for baseline-adjusted free DHA.

Icosapent ethyl: De-esterified to active metabolite (EPA) which is absorbed in the small intestine

Distribution

Vdss: EPA: ~88 L

Metabolism

EPA and DHA are mainly oxidized in the liver similar to fatty acids derived from dietary sources. EPA: minor via CYP-450

Time to Peak

Plasma:

Omega-3-carboxylic acids: Following repeat dosing with low-fat meals for ~2 weeks (steady state): EPA: 5 to 8 hours; DHA: 5 to 9 hours

Icosapent ethyl: EPA: ~5 hours

Half-Life Elimination

EPA: ~37 to 89 hours; DHA: ~46 hours

Protein Binding

EPA: >99%

Special Populations: Gender

Females tended to have more uptake of EPA into serum phospholipids than males. The clinical significance of this is unknown.

Use: Labeled Indications

Dietary supplement: As dietary supplements for patients at early risk of coronary artery disease primarily because of effects on platelets and lipids.

Note: The American Heart Association recommends that consumers without documented coronary heart disease eat a variety of fish, preferably oily fish (eg, salmon), at least twice a week. Fish oil supplements should only be considered for individuals with heart disease or high triglyceride levels in consultation with a physician (AHA 2014).

Hypertriglyceridemia (Lovaza, Omtryg, Epanova, and Vascepa): As an adjunct to diet to reduce triglyceride levels in adults with severe (≥500 mg/dL) hypertriglyceridemia.

Note: The Endocrine Society recommends that omega-3 fatty acids may be considered for triglyceride levels >1,000 mg/dL and may be used alone or in combination with HMG-CoA reductase inhibitors (Berglund 2012). A number of OTC formulations containing omega-3 fatty acids are marketed as nutritional supplements; these do not have FDA-approved indications and may not contain the same amounts of the active ingredient.

Contraindications

Hypersensitivity (eg, anaphylactic reaction) to omega-3 fatty acids or any component of formulation.

Dosing: Adult

Hypertriglyceridemia: Oral:

Epanova: 2 g (2 capsules) or 4 g (4 capsules) once daily

Lovaza: 4 g (4 capsules) once daily or 2 g (2 capsules) twice daily

Omtryg: 4.8 g (4 capsules) once daily with meals or 2.4 g (2 capsules) twice daily with meals

Vascepa: 2 g (2 [1 gram] capsules or 4 [0.5 g] capsules) twice daily with meals

Treatment of IgA nephropathy (off-label use): Oral: Lovaza: 4 g (4 capsules) once daily (Donadio 2001)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied). EPA and DHA are not renally eliminated.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied). Periodic monitoring of ALT and AST is recommended.

Administration

Epanova, Lovaza: Administer with or without food. Administer whole; do not break, crush, dissolve, or chew.

Omtryg, Vascepa: Administer with meals. Administer whole; do not break, crush, dissolve, or chew.

Dietary Considerations

Dietary modification is important in the control of severe hypertriglyceridemia. Maintain standard cholesterol-lowering diet during therapy.

Storage

Epanova, Lovaza, Omtryg: Store at 25°C (77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F); do not freeze.

Vascepa: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F).

Drug Interactions

Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): Omega-3 Fatty Acids may enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Anticoagulants: Omega-3 Fatty Acids may enhance the anticoagulant effect of Anticoagulants. Monitor therapy

Ibrutinib: Omega-3 Fatty Acids may enhance the antiplatelet effect of Ibrutinib. Monitor therapy

Adverse Reactions

>10%: Gastrointestinal: Diarrhea (7% to 15%)

1% to 10%:

Gastrointestinal: Nausea (4% to 6%), abdominal pain (3% to 5%), dysgeusia (4%), eructation (3% to 4%), dyspepsia (3%)

Neuromuscular & skeletal: Arthralgia (2%)

Frequency not defined:

Central nervous system: Fatigue

Dermatologic: Pruritus, skin rash

Endocrine & metabolic: Increased LDL cholesterol

Gastrointestinal: Abdominal distension, constipation, flatulence, gastrointestinal disease, vomiting

Hematologic & oncologic: Prolonged bleeding time

Hepatic: Increased serum ALT, increased serum AST

Respiratory: Nasopharyngitis, oropharyngeal pain

<1%, postmarketing, and/or case reports: Anaphylaxis, cardiac arrhythmia, hemorrhagic diathesis

Warnings/Precautions

Concerns related to adverse effects:

• Fish allergy: Use with caution in patients with known allergy or sensitivity to fish and/or shellfish.

• Hepatic effects: ALT may increase without concurrent AST increase; periodically monitor hepatic transaminases in patients with hepatic impairment.

• Lipid effects: May increase LDL levels; periodically monitor LDL levels.

• Prolongation of bleeding time: Prolongation of bleeding time not exceeding normal limits has been observed in some clinical studies with omega-3 fatty acids; use with caution in patients with coagulopathy or in those receiving therapeutic anticoagulation or antiplatelet therapy. Monitor for changes in INR following initiation and dosage changes of omega-3 fatty acids in patients receiving warfarin.

Disease-related concerns:

• Atrial fibrillation (AF): Omega-3 fatty acids are not indicated for the treatment of AF or flutter. Recurrent AF or flutter may occur in patients with symptomatic paroxysmal or persistent AF treated with omega-3 fatty acids; more frequent occurrences were observed with omega-3 fatty acids in the first 2 to 3 months of therapy compared to placebo in clinical trials. However, the clinical significance of these results is uncertain.

• Conditions associated with abnormal lipids: Manage concurrent conditions (eg, diabetes, hypothyroidism, excessive alcohol intake) that may contribute to lipid abnormalities.

Other warnings/precautions:

• Appropriate use: Should be used as an adjunct to diet therapy and exercise and only in those with very high triglyceride levels (≥500 mg/dL). Secondary causes of hyperlipidemia should be ruled out prior to therapy. The effect, if any, of omega-3 fatty acids on the risk of pancreatitis or cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia is not known.

Monitoring Parameters

Triglycerides and other lipids (LDL-C) should be monitored at baseline and periodically. In patients with hepatic impairment, monitor hepatic transaminase levels, particularly ALT, periodically.

2013 ACC/AHA Blood Cholesterol Guideline recommendations (Stone, 2013): Consider evaluation for GI disturbances, skin changes, and bleeding during therapy.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. Maternal dietary consumption of omega-3 fatty acids (containing eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA]) influences fetal concentrations (Coletta 2010; Miles 2011). Information specific to the therapeutic use of these products in pregnancy has not been located; however, the use of omega-3 fatty acids to manage elevated triglycerides in pregnancy has been described in case reports (Goldberg 2012; Papadakis 2011).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience burping, change in taste, nausea, or joint pain. Have patient report immediately to prescriber abnormal heartbeat, bruising, or bleeding (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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