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Included as part of the PRECAUTIONS section.

Monitoring: Laboratory Tests

In patients with hepatic impairment, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be monitored periodically during therapy with LOVAZA (omega-3-acid ethyl esters) . In some patients, increases in ALT levels without a concurrent increase in AST levels were observed.

In some patients, LOVAZA (omega-3-acid ethyl esters) increases LDL-C levels. LDL-C levels should be monitored periodically during therapy with LOVAZA (omega-3-acid ethyl esters) .

Laboratory studies should be performed periodically to measure the patient's TG levels during therapy with LOVAZA (omega-3-acid ethyl esters) .

Fish Allergy

LOVAZA (omega-3-acid ethyl esters) 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 LOVAZA (omega-3-acid ethyl esters) . LOVAZA (omega-3-acid ethyl esters) should be used with caution in patients with known hypersensitivity to fish and/or shellfish.

Patient Counseling Information

See FDA-approved patient labeling.

Information for Patients

• LOVAZA (omega-3-acid ethyl esters) should be used with caution in patients with known sensitivity or allergy to fish and/or shellfish [see WARNINGS AND PRECAUTIONS].
• Patients should be advised that use of lipid-regulating agents does not reduce the importance of adhering to diet [see DOSAGE AND ADMINISTRATION].
• Patients should be advised not to alter LOVAZA (omega-3-acid ethyl esters) capsules in any way and to ingest intact capsules only [see DOSAGE AND ADMINISTRATION].

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 grams/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 grams/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 LOVAZA (omega-3-acid ethyl esters) can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. LOVAZA (omega-3-acid ethyl esters) 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 grams/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 grams/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 grams/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 grams/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 the human systemic exposure following an oral dose of 4 grams/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 grams/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 grams/day based on a body surface area comparison).

Nursing Mothers

It is not known whether omega-3-acid ethyl esters are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when LOVAZA (omega-3-acid ethyl esters) is administered to a nursing woman.

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 LOVAZA (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: 2/10/2011
This monograph has been modified to include the generic and brand name in many instances.