Omtryg

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

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.

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.

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 antiarrhythmic 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.

Patient Counseling Information

See FDA-approved Patient Labeling (PATIENT INFORMATION)

  • Use OMTRYG with caution in patients with known sensitivity or allergy to fish and/or shellfish [see WARNINGS AND PRECAUTIONS].
  • Advise patients that use of lipid-regulating agents does not reduce the importance of adhering to diet [see DOSAGE AND ADMINISTRATION].
  • Advise patients to take OMTRYG as prescribed. If a dose is missed, patients should take it as soon as they remember. However, if they miss one day of OMTRYG, they should not double the dose when they take it.
  • Advise patients to take OMTRYG capsules with meals [see DOSAGE AND ADMINISTRATION].
  • Advise patients to swallow OMTRYG capsules whole. Do not break, open, crush, dissolve or chew OMTRYG [see DOSAGE AND ADMINISTRATION].

Patient labeling is provided as a tear-off leaflet at the end of this full prescribing information.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

In a rat carcinogenicity study with oral gavage doses of 100, 600, and 2,000 mg/kg/day, males were treated with omega-3-acid ethyl esters for 101 weeks and females for 89 weeks without an increased incidence of tumors (up to 5 times human systemic exposures following an oral dose of 4 capsules/day based on a body surface area comparison). Standard lifetime carcinogenicity bioassays were not conducted in mice.

Omega-3-acid ethyl esters were not mutagenic or clastogenic with or without metabolic activation in the bacterial mutagenesis (Ames) test with Salmonella typhimurium and Escherichia coli or in the chromosomal aberration assay in Chinese hamster V79 lung cells or human lymphocytes. Omega-3-acid ethyl esters were negative in the in vivo mouse micronucleus assay.

In a rat fertility study with oral gavage doses of 100, 600, and 2,000 mg/kg/day, males were treated for 10 weeks prior to mating and females were treated for 2 weeks prior to and throughout mating, gestation, and lactation. No adverse effect on fertility was observed at 2,000 mg/kg/day (5 times human systemic exposure following an oral dose of 4 capsules/day based on a body surface area comparison).

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. It is unknown whether OMTRYG can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. OMTRYG should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus.

Animal Data

Omega-3-acid ethyl esters have been shown to have an embryocidal effect in pregnant rats when given in doses resulting in exposures 7 times the recommended human dose of 4 capsules/day based on a body surface area comparison.

In female rats given oral gavage doses of 100, 600, and 2,000 mg/kg/day beginning 2 weeks prior to mating and continuing through gestation and lactation, no adverse effects were observed in the high dose group (5 times human systemic exposure following an oral dose of 4 capsules/day based on body surface area comparison).

In pregnant rats given oral gavage doses of 1,000, 3,000, and 6,000 mg/kg/day from gestation day 6 through 15, no adverse effects were observed (14 times human systemic exposure following an oral dose of 4 capsules/day based on a body surface area comparison).

In pregnant rats given oral gavage doses of 100, 600, and 2,000 mg/kg/day from gestation day 14 through lactation day 21, no adverse effects were seen at 2,000 mg/kg/day (5 times the human systemic exposure following an oral dose of 4 capsules/day based on a body surface area comparison). However, decreased live births (20% reduction) and decreased survival to postnatal day 4 (40% reduction) were observed in a dose-ranging study using higher doses of 3,000 mg/kg/day (7 times human systemic exposure following an oral dose of 4 capsules/day based on a body surface area comparison).

In pregnant rabbits given oral gavage doses of 375, 750, and 1,500 mg/kg/day from gestation day 7 through 19, no findings were observed in the fetuses in groups given 375 mg/kg/day (2 times human systemic exposure following an oral dose of 4 capsules/day based on a body surface area comparison). However, at higher doses, evidence of maternal toxicity was observed (4 times human systemic exposure following an oral dose of 4 capsules /day based on a body surface area comparison).

Nursing Mothers

Studies with omega-3-acid ethyl esters have demonstrated excretion in human milk. The effect of this excretion on the infant of a nursing mother is unknown; caution should be exercised when OMTRYG is administered to a nursing mother. An animal study in lactating rats given oral gavage 14C-ethyl EPA demonstrated that drug levels were 6 to 14 times higher in milk than in plasma.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

A limited number of patients older than 65 years were enrolled in the clinical studies of omega-3-acid ethyl esters. Safety and efficacy findings in subjects older than 60 years did not appear to differ from those of subjects younger than 60 years.

Last reviewed on RxList: 5/5/2014
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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