Omega-3 Fatty Acids (Lexi-Drugs)

Pronunciation

(oh MEG a three FAT tee AS ids)

Brand Names: US

Dialyvite Omega-3 Concentrate [OTC]; Expecta LIPIL [OTC] [DSC]; Fish Oil Concentrate [OTC]; Lovaza; Maximum Red Krill [OTC]; Ocean Blue MiniCaps Omega-3 [OTC]; Odorless Coated Fish Oil [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]; Triklo [DSC]; Vascepa

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

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

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

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

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: Adult

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

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: Prior recommendations from the American Heart Association (AHA) stated that patients without documented coronary heart disease (CHD) should eat a variety of fish, preferably oily fish (eg, salmon), at least twice a week, or daily (as oily fish, but omega-3 fatty acids may be considered) in patients with documented CHD (AHA [Kris-Etherton 2002]). According to the most recent AHA recommendations, the use of omega-3 fatty acids is reasonable only for the secondary prevention of CHD and sudden cardiac death among patients with prevalent CHD and secondary prevention of outcomes in patients with heart failure (AHA [Siscovick 2017]).

Hypertriglyceridemia (Lovaza, 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.

Use: Off-Label: Adult

  IgA nephropathyLevel of Evidence [B, G]

Data from a randomized, open-label, parallel-group clinical trial supports the use of omega-3 fatty acids Ref in the treatment (ie, slowing rate of renal function loss) of IgA nephropathy Ref. A more recent meta-analysis does not confirm the efficacy for this indication, though it may likely be used for this indication Ref. Additional trials may be necessary to further define the role of omega-3 fatty acids in the treatment of patients with IgA nephropathy.

Based on the Caring for Australasians with Renal Impairment (CARI) guidelines early and prolonged treatment with fish oil may retard the rate of decline in renal function in adults with progressive IgA nephropathy; optimal dosing has yet to be established Ref. Routine use is currently not recommended (Laville 2004).

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Bipolar Disorder:

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD), “Collaborative Update of CANMAT Guidelines for the Management of Patients with Bipolar Disorder – Update 2013,” February 2013

Dyslipidemia:

AACE/ACE, “Guidelines for Management of Dyslipidemia and Prevention of Cardiovascular Disease,” April 2017

ACC/AHA, “2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults,” November 2013

AHA/ACC, “Guideline on the Management of Blood Cholesterol,” November 2018

NLA, “National Lipid Association Recommendations for Patient-Centered Management of Dyslipidemia” Part 1: April 2015Part 2: December 2015

The Endocrine Society, “Evaluation and Treatment of Hypertriglyceridemia: An Endocrine Society Clinical Practice Guideline,” September 2012

Prevention:

AHA, “Omega-3 Polyunsaturated Fatty Acid (Fish Oil) Supplementation and the Prevention of Clinical Cardiovascular Disease: A Science Advisory From the American Heart Association,” March 2017

Administration: Oral

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

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/Stability

Epanova, Lovaza: 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).

Medication Patient Education with HCAHPS Considerations

• 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, abdominal pain, joint pain, or diarrhea. 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.

Medication Safety Issues
  Sound-alike/look-alike issues:
  International issues:
  Other safety concerns:
Contraindications

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

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.

Geriatric Considerations

Specific information about the safety and efficacy of omega-3-acid ethyl esters is limited. The manufacturer states there were no apparent differences between persons <60 and >60 years of age.

The definition of and, therefore, when to treat hyperlipidemia in the elderly is a controversial issue. According to the ACC/AHA guidelines for adult patients, there are no supporting data for the routine use of nonstatin drugs in combination with a statin to further reduce clinical atherosclerotic cardiovascular disease (ASCVD) events. Evidence for nonstatins in statin-intolerant patients is lacking. Furthermore, there are no data or recommendations on managing patients >75 years of age without clinical ASCVD who have type 1 or 2 diabetes or with a 10-year risk of ASCVD >7.5% (with or without diabetes) (Stone 2013). It is the authors’ belief that pharmacologic treatment be reserved for those whom the benefits of treatment are believed to outweigh the potential adverse effects, drug interactions, and cost of treatment.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. Adequate intake of omega-3 fatty acids is recommended during pregnancy (IOM 2005; Nordgren 2017). Maternal use of supplements or dietary consumption of omega-3 fatty acids (containing eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA]) influences fetal concentrations (Büyükuslu 2017; Coletta 2010; Miles 2011).

Triglyceride concentrations increase during pregnancy as required for normal fetal development. When increases are greater than expected, supervised dietary interventions that include omega-3 fatty acids may be initiated. In women who develop very severe hypertriglyceridemia and are at risk for pancreatitis, use of prescription omega-3 fatty acid products may be considered (Avis 2009; Berglund 2012; Jacobson 2015; Wong 2015).

Breast-Feeding Considerations

Omega-3 fatty acids are present in breast milk and dietary supplementation may influence milk concentrations (IOM 2005). According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Briggs’ Drugs in Pregnancy & Lactation
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

Metabolism/Transport Effects

None known.

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. Risk C: Monitor therapy

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

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

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.

Advanced Practitioners Physical Assessment/Monitoring

Determine if patient is allergic to fish prior to prescribing. Encourage diet and exercise along with use of this medication. Monitor liver function studies, LDL-C, and TG prior to and as clinically indicated during therapy. Concomitant use with blood thinning medications may increase risk of bleeding. Monitor for signs and symptoms of bleeding.

Nursing Physical Assessment/Monitoring

Do not use if allergic to fish. Encourage diet and exercise along with use of this medication. Discuss fish oils when used with other blood thinning medications (ie. Coumadin ®, Plavix® and aspirin) may increase their effects.

Product Availability

Epanova: FDA approved May 2014; anticipated availability is currently unknown.

Dosage Forms Considerations

Epanova: Each 1 g capsule contains at least 850 mg of polyunsaturated fatty acids, including multiple omega-3 fatty acids (eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] being the most abundant).

Lovaza: Each 1 g capsule contains the combination of EPA (~465 mg) and DHA (~375 mg) ethyl esters.

Vascepa: Icosapent ethyl contains ethyl esters of an omega-3 fatty acid, EPA, obtained from fish oil. It contains ≥96% EPA and does not contain DHA. Historically, mixtures containing both EPA and DHA have increased LDL cholesterol in patients with severe hypertriglyceridemia. However, studies have suggested that icosapent ethyl has not caused significant increases in LDL cholesterol while significantly decreasing triglyceride levels (Bays 2011; Miller 2011).

Dosage Forms: US

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]

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]

Triklo: 1 g [DSC]

Vascepa: 0.5 g, 1 g

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

Capsule, Oral [preservative free]:

Fish Oil Concentrate: 1000 mg [gluten free, lactose free, milk free, no artificial color(s), no artificial flavor(s), no artificial sweetener, sodium free, starch 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:

Odorless Coated Fish Oil: 1000 mg [gluten free, lactose free, milk free, no artificial color(s), no artificial flavor(s), no artificial sweetener, starch free, sugar free, wheat free, yeast free]

Pro Nutrients Omega 3: 332.5 mg

Generic: 1000 mg

Tablet Chewable, Oral:

Omega-3 IQ: 240 mg [fruit flavor]

Anatomic Therapeutic Chemical (ATC) Classification
  • C10AX06
Generic Available (US)

May be product dependent

Pricing: US

Capsule, delayed release (Pro Nutrients Omega 3 Oral)

332.5 mg (per each): $0.16

Capsules (Dialyvite Omega-3 Concentrate Oral)

600 mg (per each): $0.16

Capsules (Lovaza Oral)

1 g (per each): $2.99

Capsules (Ocean Blue MiniCaps Omega-3 Oral)

350 mg (per each): $0.36

Capsules (Omega Power Oral)

1050 mg (per each): $0.56

Capsules (Omega-3 2100 Oral)

1050 mg (per each): $0.26

Capsules (Omega-3-acid Ethyl Esters Oral)

1 g (per each): $2.07 – $2.69

Capsules (Sea-Omega Oral)

1000 mg (per each): $0.14

Capsules (Vascepa Oral)

0.5 g (per each): $1.78

1 g (per each): $3.04

Chewable (Omega-3 IQ Oral)

240 mg (per each): $0.25

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

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.

Pharmacodynamics/Kinetics

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

Protein binding: EPA: >99%

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

Half-life elimination: EPA: ~37 to 89 hours; DHA: ~46 hours

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

Pharmacodynamics/Kinetics: Additional Considerations

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

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

Prolongation of bleeding time has been observed in some clinical studies; however, there is no scientific evidence to warrant discontinuance prior to dental surgery. The clinician should anticipate the potential for slower clotting times.

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; P-OM3

References

Avis HJ, Hutten BA, Twickler MT, et al. Pregnancy in women suffering from familial hypercholesterolemia: a harmful period for both mother and newborn? Curr Opin Lipidol. 2009;20(6):484-490. doi: 10.1097/MOL.0b013e3283319127.[PubMed 19741526]

Bays HE, Ballantyne CM, Kastelein JJ, Isaacsohn JL, Braeckman RA, Soni PN. Eicosapentaenoic acid ethyl ester (AMR101) therapy in patients with very high triglyceride levels (from the Multi-center, Placebo-controlled, Randomized, Double-blind, 12-week study with an open-label Extension [Marine] trial. Am J Cardiol. 2011;108(5):682-690.[PubMed 21683321]

Berglund L, Brunzell JD, Goldberg AC, et al, “Evaluation and Treatment of Hypertriglyceridemia: An Endocrine Society Clinical Practice Guideline,” J Clin Endocrinol Metab, 2012, 97(9):2969-89.[PubMed 22962670]

Büyükuslu N, Ovalı S, Altuntaş ŞL, Batırel S, Yiğit P, Garipağaoğlu M. Supplementation of docosahexaenoic acid (DHA) / Eicosapentaenoic acid (EPA) in a ratio of 1/1.3 during the last trimester of pregnancy results in EPA accumulation in cord blood. Prostaglandins Leukot Essent Fatty Acids. 2017;125:32-36. doi: 10.1016/j.plefa.2017.08.005.[PubMed 28987719]

Coletta JM, Bell SJ, Roman AS. Omega-3 Fatty acids and pregnancy. Rev Obstet Gynecol. 2010;3(4):163-171.[PubMed 21364848]

Donadio JV and Grande JP, “The Role of Fish Oil/Omega-3 Fatty Acids in the Treatment of IgA Nephropathy,” Semin Nephrol, 2004, 24(3):225-43.[PubMed 15156528]

Donadio JV Jr, Larson TS, Bergstralh EJ, et al, “A Randomized Trial of High-Dose Compared With Low-Dose Omega-3 Fatty Acids in Severe IgA Nephropathy,” J Am Soc Nephrol, 2001, 12(4):791-9.[PubMed 11274240]

Durrington PN, Bhatnagar D, Mackness MI, et al, “An Omega-3 Polyunsaturated Fatty Acid Concentrate Administered for One Year Decreased Triglycerides in Simvastatin Treated Patients With Coronary Heart Disease and Persisting Hypertriglyceridaemia,” Heart, 2001, 85(5):544-8.[PubMed 11303007]

Epanova (omega-3-carboxylic acids) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals; March 2017.

Goldberg AS, Hegele RA. Severe hypertriglyceridemia in pregnancy. J Clin Endocrinol Metab. 2012;97(8):2589-2596.[PubMed 22639290]

Harris D, Thomas M, Johnson D, Nicholls K, Gillin A; Caring for Australasians with Renal Impairment (CARI). The CARI guidelines. Prevention of progression of kidney disease. Nephrology (Carlton). 2006;11(suppl 1):S2-S197.[PubMed 16684077]

Harris WS, Ginsberg HN, Arunakul N, et al, “Safety and Efficacy of Omacor in Severe Hypertriglyceridemia,” J Cardiovasc Risk, 1997, 4(5-6):385-91.[PubMed 9865671]

IOM (Institute of Medicine). Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, DC: The National Academies Press. 2005.

Jacobson TA, Maki KC, Orringer CE, et al; NLA Expert Panel. National Lipid Association recommendations for patient-centered management of dyslipidemia: part 2 [published correction appears in: J Clin Lipidol. 2016;10(1):211.]. J Clin Lipidol. 2015;9(6)(suppl):S1-S122.e1. doi: 10.1016/j.jacl.2015.09.002.[PubMed 26699442]

Kotwal S, Jun M, Sullivan D, et al, “Omega 3 Fatty Acids and Cardiovascular Outcomes: Systematic Review and Meta-Analysis,” Circ Cardiovasc Qual Outcomes, 2012, 5(6):808-18.[PubMed 23110790]

Kowey PR, Reiffel JA, Ellenbogen KA, et al, “Efficacy and Safety of Prescription Omega-3 Fatty Acids for the Prevention of Recurrent Symptomatic Atrial Fibrillation: A Randomized Controlled Trial,” JAMA, 2010, 304(21):2363-72.[PubMed 21078810]

Kris-Etherton PM, Harris WS, Appel LJ; American Heart Association (AHA). Nutrition Committee. Fish consumption, fish oil, omega-3 fatty acids, and cardiovascular disease. Circulation. 2002;106(21):2747-2757. Erratum in Circulation. 2003;107(3):512.[PubMed 12438303]

Laville M, Alamartine E. Treatment options for IgA nephropathy in adults: a proposal for evidence-based strategy. Nephrol Dial Transplant. 2004;19(8):1947-1951.[PubMed 15161954]

Liu L, Wang L. Omega-3 fatty acids therapy for IgA nephropathy: a meta-analysis of randomized controlled trials. Clin Nephrol. 2012;77(2):119-125.[PubMed 22257542]

Lovaza (omega-3-acid ethyl esters) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; September 2015.

Macchia A, Grancelli H, Varini S, et al, “Omega-3 Fatty Acids for the Prevention of Recurrent Symptomatic Atrial Fibrillation,” J Am Coll Cardiol, 2013, 61(4):463–8.[PubMed 23265344]

Miles EA, Noakes PS, Kremmyda LS, et al. The Salmon in Pregnancy Study: study design, subject characteristics, maternal fish and marine n-3 fatty acid intake, and marine n-3 fatty acid status in maternal and umbilical cord blood. Am J Clin Nutr. 2011;94(6 suppl):1986S-1992S.[PubMed 21849598]

Miller M, Stone NJ, Ballantyne C, et al. Triglycerides and cardiovascular disease: a scientific statement from the American Heart Association. Circulation. 2011;123(20):2292-2333.[PubMed 21502576]

Mozaffarian D, Marchioli R, Macchia A, et al, “Fish Oil and Postoperative Atrial Fibrillation: The Omega-3 Fatty Acids for Prevention of Post-operative Atrial Fibrillation (OPERA) Randomized Trial,” JAMA, 2012, 308(19):2001-11.[PubMed 23128104]

Nodari S, Triggiani M, Campia U, et al, “n-3 Polyunsaturated Fatty Acids in the Prevention of Atrial Fibrillation Recurrences after Electrical Cardioversion: A Prospective, Randomized Study,” Circulation, 2011, 124(10):1100-6.[PubMed 21844082]

Nordgren TM, Lyden E, Anderson-Berry A, Hanson C. Omega-3 fatty acid intake of pregnant women and women of childbearing age in the United States: potential for deficiency? Nutrients. 2017;9(3).pii:E197. doi: 10.3390/nu9030197.[PubMed 28245632]

Omega-3 fatty acids [prescribing information]. Tempe, AZ: Century HealthCare Inc; received July 2018.

Papadakis EP, Sarigianni M, Mikhailidis DP, Mamopoulos A, Karagiannis V. Acute pancreatitis in pregnancy: an overview. Eur J Obstet Gynecol Reprod Biol. 2011;159(2):261-266.[PubMed 21840110]

Rizos EC, Ntzani EE, Bika E, et al, “Association Between Omega-3 Fatty Acid Supplementation and Risk of Major Cardiovascular Disease Events: A Systematic Review and Meta-analysis,” JAMA, 2012, 308(10):1024-33.[PubMed 22968891]

Siscovick DS, Barringer TA, Fretts AM, Wu JH, Lichtenstein AH, Costello RB, Kris-Etherton PM; American Heart Association Nutrition Committee of the Council on Lifestyle and Cardiometabolic Health; Council on Epidemiology and Prevention; Council on Cardiovascular Disease in the Young; Council on Cardiovascular and Stroke Nursing; and Council on Clinical Cardiology. Omega-3 polyunsaturated fatty acid (fish oil) supplementation and the prevention of clinical cardiovascular disease: a science advisory from the American Heart Association. Circulation. 2017;135(15):e867-e884. doi: 10.1161/CIR.0000000000000482.[PubMed 28289069]

Stalenhoef AF, de Graaf J, Wittekoek ME, et al, “The Effect of Concentrated n-3 Fatty Acids Versus Gemfibrozil on Plasma Lipoproteins, Low Density Lipoprotein Heterogeneity and Oxidizability in Patients With Hypertriglyceridemia,” Atherosclerosis, 2000, 153(1):129-38.[PubMed 11058707]

Stone NJ, Robinson J, Lichtenstein AH, et al, 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines [published online ahead of print November 12, 2013]. Circulation. 2013; doi: 10.1161/01.cir.0000437738.63853.7a.[PubMed 24222016]

Vascepa (icosapent ethyl) [prescribing information]. Bedminster, NJ: Amarin Pharma Inc; February 2017.

Wong B, Ooi TC, Keely E. Severe gestational hypertriglyceridemia: A practical approach for clinicians. Obstet Med. 2015;8(4):158-167. doi: 10.1177/1753495X15594082.[PubMed 27512474]

Brand Names: International

Agemo (PK); Dualtis (GB); Epax (EC); Equiplen (PE); Nebbaro (GB); Omacor (AE, AR, AT, AU, BE, BG, BH, CR, CY, CZ, DE, DO, EE, ES, FI, FR, GB, GR, GT, HN, HR, HU, IE, IL, KR, KW, LK, LT, LU, LV, MT, MY, NI, NL, NO, PA, PL, PT, QA, RO, RU, SA, SI, SK, SV, TH, UA); Omaron (KR); Ysomega (FR)

Omega-3 Fatty Acids (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(oh MEG a three FAT tee AS ids)

Brand Names: US

Dialyvite Omega-3 Concentrate [OTC]; Expecta LIPIL [OTC] [DSC]; Fish Oil Concentrate [OTC]; Lovaza; Maximum Red Krill [OTC]; Ocean Blue MiniCaps Omega-3 [OTC]; Odorless Coated Fish Oil [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]; Triklo [DSC]; Vascepa

What is this drug used for?
  • It is used to lower triglycerides.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to omega-3 fatty acids or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • This drug may interact with other drugs or health problems.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • If you are allergic to fish, fish oil, or shellfish, talk with your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Follow the diet and workout plan that your doctor told you about.
  • Talk with your doctor before you drink alcohol.
  • If you have a heart rhythm problem called atrial fibrillation (Afib) or flutter, talk with your doctor. People with these health problems have had them happen more often while taking omega-3 fatty acids, especially in the first few months.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • A heartbeat that does not feel normal.
  • Any unexplained bruising or bleeding.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Icosapent ethyl:
  • Joint pain.
  • All other products:
  • Burping.
  • Change in taste.
  • Upset stomach.
  • Diarrhea.
  • Belly pain.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • Icosapent ethyl:
  • Take this drug with food.
  • All other products:
  • Some drugs may need to be taken with food or on an empty stomach. For some drugs it does not matter. Check with your pharmacist about how to take this drug.
  • All products:
  • Swallow whole. Do not chew, break, open, or dissolve.
  • If you have trouble swallowing, talk with your doctor.
  • To gain the most benefit, do not miss doses.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
What do I do if I miss a dose?
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature. Do not freeze.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.