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Omega-3 Dyslipidemic Agents
Mixtures of ethyl esters or free fatty acids derived from fish oil primarily composed of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)Used as an adjunct to diet to reduce triglyceride levels in adult patients with severe (500 mg/dL or greater) hypertriglyceridemiaUnknown effect on the risk for pancreatitis or cardiovascular morbidity and mortality
Lovaza, Omacor, Triklo
Lovaza/Omacor/Omega-3-Acid Ethyl Esters/Omega-3-Acid Ethyl Esters, Eicosapentaenoic Acid (EPA), Docosahexaenoic Acid (DHA)/Triklo Oral Cap: 1g, 465-375mg
A dosage of 4 g/day PO as a single dose plus simvastatin 40 mg/day PO has been used in one study evaluating 254 adults with hypertriglyceridemia. At the end of the 8-week treatment regimen, the median percent change in non-HDL-C was significantly greater with Lovaza plus simvastatin compared with placebo plus simvastatin (-9.0% vs. -2.2%, respectively; p less than 0.0001). Compared to simvastatin monotherapy, Lovaza plus simvastatin resulted in significant reductions in triglycerides (29.5% vs. 6.3%, p less than 0.0001) and very low-density lipoprotein cholesterol (27.5% vs. 7.2%, p less than 0.05), and a significant increase in high-density lipoprotein cholesterol (+3.4% vs. -1.2%, p less than 0.05).
4 capsules/day PO, either as a single dose PO once per day or as 2 capsules PO twice daily. The effect of treatment on the risk for pancreatitis and cardiovascular morbidity/mortality in patients with severe hypertriglyceridemia has not been determined.
2 or 4 g (2 or 4 capsules) PO once daily. Individualize dosage according to response and tolerability. The effect of treatment on the risk for pancreatitis and cardiovascular morbidity/mortality in patients with severe hypertriglyceridemia has not been determined.
4 capsules/day PO.
Safety and efficacy have not been established.
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
Lovaza:Take with or without food. In clinical trials, Lovaza capsules were administered with meals.Capsules should be swallowed whole. Advise patients not to break open, crush, dissolve or chew.Omtryg:Take with meals.Capsules should be swallowed whole. Advise patients not to break open, crush, dissolve or chew.Epanova:Take with or without food. In clinical trials, Epanova capsules were administered without regard to meals.Capsules should be swallowed whole. Advise patients not to break open, crush, dissolve or chew.
Lovaza:- Do not freeze- Protect from light- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees FOmacor:- Do not freeze- Protect from light- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees FTriklo:- Do not freeze- Protect from light- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Fish oil, omega-3-fatty acids are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to fish oil, omega-3-fatty acids or any of its components. Use with caution in patients with known fish hypersensitivity. These products are derived from fish oils. It is not known whether patients with allergies to fish and/or shellfish are at increased risk of an allergic reaction.
Because fish oil, omega-3 fatty acids may increase LDL or total serum cholesterol, they should be used cautiously in patients with hypercholesterolemia or mixed dyslipidemias. As with any lipid-regulating product, LDL-C levels should be monitored periodically.
Because fish oil, omega-3 fatty acids inhibit platelet aggregation, caution is advised when fish oils are used concurrently with anticoagulant therapy, thrombolytic therapy, or anti-platelet therapy. Theoretically, the risk of bleeding may be increased, but some studies have not shown clinically significant bleeding events with concurrent use. Periodically monitor patients receiving concurrent therapy with fish oils and drugs affecting coagulation for bleeding.
A possible association exists between omega-3-acid ethyl esters and more frequent recurrences of symptomatic atrial fibrillation (AF) or atrial flutter in patients with paroxysmal or persistent AF, particularly within the first 2—3 months of initiating therapy. The clinical significance is uncertain.
Use fish oil, omega-3 fatty acids during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown whether fish oil, omega-3 fatty acids can cause fetal harm or affect reproductive capacity. A 20% reduction in live births and 40% reduction in pup survival to postnatal day 4 were observed following oral administration of fish oil, omega-3 fatty acid to pregnant rats at doses 7-times the maximum recommended human dose (MRHD).
Use fish oil, omega-3 fatty acids with caution in breast-feeding mothers. Studies demonstrate excretion in human milk; however, the effect of this excretion on the infant is unknown. An animal study in lactating rates demonstrated drug concentrations were 6- to 14-times higher in milk than in plasma.
coagulopathy / Delayed / Incidence not knownanaphylactoid reactions / Rapid / Incidence not knownatrial flutter / Early / Incidence not knownatrial fibrillation / Early / Incidence not known
constipation / Delayed / Incidence not knownprolonged bleeding time / Delayed / Incidence not knownelevated hepatic enzymes / Delayed / Incidence not knownhypercholesterolemia / Delayed / Incidence not known
diarrhea / Early / 7.0-15.0nausea / Early / 4.0-6.0abdominal pain / Early / 3.0-5.0dysgeusia / Early / 4.0-4.0eructation / Early / 3.0-4.0dyspepsia / Early / 3.0-3.0rash / Early / 1.8-1.8vomiting / Early / Incidence not knownecchymosis / Delayed / Incidence not knownepistaxis / Delayed / Incidence not knownurticaria / Rapid / Incidence not knownpruritus / Rapid / Incidence not knownfatigue / Early / Incidence not knownpharyngitis / Delayed / Incidence not knownarthralgia / Delayed / Incidence not known
There are no drug interactions associated with Fish Oil, Omega-3 Fatty Acids (FDA-approved) products.
The mechanism of action of fish oil, omega-3 fatty acids for the treatment of hypertriglyceridemia is not completely understood. Omega-3 fatty acids reduce the hepatic production of triglyceride (TG)-rich very-low-density lipoproteins and may increase the removal rate of TG-rich lipoproteins by increasing lipoprotein lipase activity. Inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase, increased mitochondrial and hepatic peroxisomal beta-oxidation, decreased hepatic lipogenesis, and increased plasma lipoprotein lipase activity are potential mechanisms of action.
Fish oil, omega-3 fatty acids is administered orally. When administered as ethyl esters, omega-3 fatty acids induce significant, dose-dependent increases in serum phospholipid eicosapentaenoic acid (EPA) content. Increases in docosahexaenoic acid (DHA) content were less marked and not dose-dependent when administered as ethyl esters.  Following repeat dosing of omega-3 carboxylic acids under low-fat meal conditions for approximately 2 weeks, maximum plasma concentrations are achieved 5 to 8 hours after dosing for total EPA and between 5 to 9 hours after dosing for total DHA. Steady-state concentrations of EPA and DHA in plasma are achieved within 2 weeks of repeat daily dosing with omega-3 carboxylic acids. EPA and DHA from omega-3 carboxylic acids are mainly oxidized in the liver similar to fatty acids derived from dietary sources. Affected cytochrome P450 isoenzymes: noneWhile omega-3-fatty acid containing products have shown increased hepatic concentrations of CYP450 and activities of certain CYP450 isoenzymes in rats, the potential to induce CYP450 activities in humans has not been studied. However, the free forms of the EPA and DHA are typically undetectable in human circulation. Clinically significant interactions of fish oil, omega-3 fatty acids with other drugs due to inhibition or induction of CYP450 mediated metabolism are not expected.  
Lovaza: Lovaza was administered with meals in clinical trials. Omtryg: Administration of Omtryg under fasted condition in clinical trials resulted in decreases in the peak (Cmax) and total (AUC0-72h) exposure by up to 20 to 80-fold, respectively, for total plasma EPA and by up to 2 to 4-fold, respectively, for total plasma DHA, in comparison to those observed under fed condition (high-fat high-calorie meal). Epanova: Epanova was administered without regard to meals in clinical trials. Administration of a single dose of Epanova with a high-fat meal increased the overall exposure of total and free baseline-adjusted EPA by approximately 140% and 80%, respectively, compared to fasting conditions. There was no change in overall exposure of baseline-adjusted total DHA; however, there was a 40% increase in AUC for baseline-adjusted free DHA. Overall exposures of unadjusted total and free EPA increased by 80% and 50%, respectively, although there was no change in overall exposure for unadjusted total and free DHA.