Omtryg

OMTRYG- omega-3-acid ethyl esters capsule
Trygg Pharma Inc

1 INDICATIONS AND USAGE

OMTRYG™ (omega-3-acid ethyl esters) capsules, USP, is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.

Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving OMTRYG and should continue this diet during treatment with OMTRYG.

Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting OMTRYG therapy. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems, such as diabetes mellitus and hypothyroidism, that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy.

Limitations of Use:

The effect of OMTRYG on the risk for pancreatitis has not been determined.

The effect of OMTRYG on cardiovascular mortality and morbidity has not been determined.

2 DOSAGE AND ADMINISTRATION

Assess triglyceride levels carefully before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) of high triglyceride levels and manage as appropriate. [see Indications and Usage (1)].
Patients should be placed on an appropriate lipid-lowering diet before receiving OMTRYG and should continue this diet during treatment with OMTRYG.

The daily dose of OMTRYG is 4 capsules per day taken as a single dose (4 capsules) or as 2 capsules given twice daily. OMTRYG should be taken with meals. [see Clinical Pharmacology (12.3)]

Patients should be advised to swallow OMTRYG capsules whole. Do not break open, crush, dissolve or chew OMTRYG.

3 DOSAGE FORMS AND STRENGTHS

OMTRYG (omega-3-acid ethyl esters) capsules, USP, are supplied as 1.2-gram, transparent, soft-gelatin capsules filled with light-yellow oil and bearing the designation TP0001.

4 CONTRAINDICATIONS

OMTRYG is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any component of OMTRYG.

5 WARNINGS AND PRECAUTIONS

5.1 Monitoring: Laboratory Tests

In patients with hepatic impairment, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be monitored periodically during therapy with OMTRYG. In some patients, increases in ALT levels without a concurrent increase in AST levels were observed.

In some patients, OMTRYG increases LDL-cholesterol levels. LDL-cholesterol levels should be monitored periodically during therapy with OMTRYG.

5.2 Fish Allergy

OMTRYG contains ethyl esters of omega-3 fatty acids (EPA and DHA) obtained from the oil of several fish sources. It is not known whether patients with allergies to fish and/or shellfish are at increased risk of an allergic reaction to OMTRYG. OMTRYG should be used with caution in patients with known hypersensitivity to fish and/or shellfish.

5.3 Recurrent Atrial Fibrillation (AF) or Flutter

In a double-blind, placebo-controlled trial of 663 patients with symptomatic paroxysmal AF (n=542) or persistent AF (n=121), recurrent AF or flutter was observed in patients randomized to omega-3-acid ethyl esters who received 8 capsules/day for 7 days and 4 capsules/day thereafter for 23 weeks at a higher rate relative to placebo. Patients in this trial had median baseline triglycerides of 127 mg/dL, had no substantial structural heart disease, were taking no anti-arrhythmic therapy (rate control permitted), and were in normal sinus rhythm at baseline.

At 24 weeks, in the paroxysmal AF stratum, there were 129 (47%) first recurrent symptomatic AF or flutter events on placebo and 141 (53%) on omega-3-acid ethyl esters [primary endpoint, HR 1.19; 95% CI 0.93, 1.35]. In the persistent AF stratum, there were 19 (35%) events on placebo and 34 (52%) events on omega-3-acid ethyl esters [HR 1.63; 95% CI 0.91, 2.18]. For both strata combined, the HR was 1.25; 95% CI 1.00, 1.40. Although the clinical significance of these results is uncertain, there is a possible association between omega-3-acid ethyl esters and more frequent recurrences of symptomatic atrial fibrillation or flutter in patients with paroxysmal or persistent atrial fibrillation, particularly within the first 2 to 3 months of initiating therapy.

OMTRYG is not indicated for the treatment of AF or flutter.

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse reactions reported in at least 3% and at a greater rate than placebo for patients treated with omega-3-acid ethyl esters based on pooled data across 23 clinical studies are listed in Table 1.

Table 1. Adverse Reactions Occurring at Incidence ≥3% and Greater than Placebo in Clinical Studies of Omega-3-Acid Ethyl Esters
* Studies included subjects with HTG and severe HTG.† OMTRYG and omega-3-acid ethyl esters each contain, among other components, at least 900 mg per capsule of ethyl esters from omega-3 fatty acids sourced from fish oils.

Body System

Omega-3-Acid Ethyl Esters†(N = 655)

Placebo(N = 370)

Adverse Reaction*

n

%

n

%

Eructation

29

4

5

1

Dyspepsia

22

3

6

2

Taste perversion

27

4

1

<1

Additional adverse reactions from clinical studies are listed below:

Digestive System: Constipation, gastrointestinal disorder and vomiting.

Metabolic and Nutritional Disorders: Increased ALT and increased AST.

Skin: Pruritus and rash.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of omega-3-acid ethyl esters. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following events have been reported: anaphylactic reaction, hemorrhagic diathesis.

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