ICOSAPENT ETHYL capsule

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

ICOSAPENT ETHYL (UNII: 6GC8A4PAYH) (Icosapent - UNII:AAN7QOV9EA)

متاح من:

Apotex Corp

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Icosapent ethyl capsules are indicated: - as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Limitations of Use: The effect of icosapent ethyl capsules on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Icosapent ethyl capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to icosapent ethyl or any of its components. Risk Summary The available data from published case reports and the pharmacovigilance database on the use of icosapent ethyl capsules in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies in pregnant rats, non-dose-related imbalances for some minor developmental findings were observed with oral administration of icosapent ethyl during organogenesis at exposures that were equivalent to the clinical exposure at the human dose of 4 g/day, based on body surface area comparisons. In a study in pregnant rabbits orally administered icosapent ethyl during organogenesis, there were no clinically relevant adverse developmental effects at exposures that were 5 times the clinical exposure, based on body surface area comparisons (see Data) .   The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In pregnant rats given oral gavage doses of 0.3, 1 and 2 g/kg/day icosapent ethyl from gestation through organogenesis all drug treated groups had non-dose-related imbalances in visceral and skeletal findings, including 13th  reduced ribs, additional liver lobes, testes medially displaced and/or not descended at human systemic exposures following a maximum oral dose of 4 g/day based on body surface comparisons.   In a multigenerational developmental study in pregnant rats given doses of 0.3, 1, 3 g/kg/day icosapent ethyl by oral gavage from gestation day 7-17, icosapent ethyl did not affect viability in fetuses (F1 or F2). Non-dose-related imbalances in findings of absent optic nerves and unilateral testes atrophy at human exposures based on the maximum dose of 4 g/day and on body surface area comparisons.  Additional variations consisting of early incisor eruption and increased percent cervical ribs were observed at the same exposures. Pups from high dose treated dams exhibited decreased copulation rates, delayed estrus, decreased implantations and decreased surviving fetuses (F2) suggesting potential multigenerational effects of icosapent ethyl at 7 times human systemic exposure following 4 g/day dose based on body surface area comparisons across species.  In pregnant rabbits given oral gavage doses of 0.1, 0.3, and 1 g/kg/day icosapent ethyl from gestation through organogenesis, a decrease in body weight and food consumption was observed at the high dose of 1 g/kg/day (5 times the human exposure at the maximum dose of 4 g/day, based on body surface area comparisons). Slight increases in resorbed and dead fetuses were noted in the 1 g/kg/day group, but these were not significantly different from the control group. There were no differences between the icosapent ethyl groups and control group as to the number of corpora lutea, number of implantations, number of surviving fetuses, sex ratio, body weight of female fetuses or placental weight. There were no treatment-related malformations or skeletal anomalies.  In pregnant rats given icosapent ethyl from gestation day 17 through lactation day 20 at 0.3, 1, 3 g/kg/day no adverse maternal or developmental effects were observed. However, complete litter loss (not dose-related) was noted in 2/23 litters at the low dose and 1/23 mid-dose dams by post-natal day 4 at human exposures at a maximum dose of 4 g/day, based on body surface area comparisons. Risk Summary Published studies have detected omega-3 fatty acids, including EPA, in human milk. Lactating women receiving oral omega-3 fatty acids for supplementation have resulted in higher levels of omega-3 fatty acids in human milk. There are no data on the effects of omega-3 fatty acid ethyl esters on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for icosapent ethyl capsules and any potential adverse effects on the breastfed child from icosapent ethyl or from the underlying maternal condition. Safety and effectiveness in pediatric patients have not been established. Of the total number of patients in well-controlled clinical studies of icosapent ethyl, 45% were 65 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger groups. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In patients with hepatic impairment, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be monitored periodically during therapy with icosapent ethyl capsules.

ملخص المنتج:

Icosapent ethyl capsules are supplied as 1 gram oblong, natural colored transparent soft gelatin capsules with the logo “A1000” printed in white ink. Bottles of 120: NDC 60505-4033-1. Store at 20°C to 25° C (68°F to 77°F); excursions permitted from 15°C to 30° C (59°F to 86°F) [see USP Controlled Room Temperature].

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

ICOSAPENT ETHYL- ICOSAPENT ETHYL CAPSULE
APOTEX CORP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ICOSAPENT ETHYL
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ICOSAPENT ETHYL
CAPSULES.
ICOSAPENT ETHYL CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2012
RECENT MAJOR CHANGES
Indications and Usage (1) 12/2019
Warnings and Precautions, Atrial Fibrillation/Flutter (5.1) 12/2019
Warnings and Precautions, Bleeding (5.3) 12/2019
INDICATIONS AND USAGE
Icosapent ethyl capsules are an ethyl ester of eicosapentaenoic acid
(EPA) indicated:
as an adjunct to diet to reduce triglyceride (TG) levels in adult
patients with severe (≥ 500 mg/dL)
hypertriglyceridemia. (1)
Limitations of Use:
The effect of icosapent ethyl capsules on the risk for pancreatitis in
patients with severe
hypertriglyceridemia has not been determined. (1)
DOSAGE AND ADMINISTRATION
Assess lipid levels before initiating therapy. Identify other causes
of high triglyceride levels and manage
as appropriate. (2.1)
Patients should engage in appropriate nutritional intake and physical
activity before receiving icosapent
ethyl capsules, which should continue during treatment. (2.1)
The daily dose of icosapent ethyl capsules is 4 grams per day taken as
two 1 gram capsules twice daily with food. (2.2)
Advise patients to swallow capsules whole. Do not break open, crush,
dissolve, or chew icosapent ethyl
capsules. (2.2)
DOSAGE FORMS AND STRENGTHS
Capsules: 1 gram (3)
CONTRAINDICATIONS
Icosapent ethyl capsules are contraindicated in patients with known
hypersensitivity (e.g.,
anaphylactic reaction) to icosapent ethyl or any of its components.
(4)
WARNINGS AND PRECAUTIONS
_Atrial Fibrillation/Flutter:_ Icosapent ethyl capsules were
associated with an increased risk of atrial fibrillation
or atrial flutter requiring hospitalization in a double-blind
placebo-controlled trial. The incidence of atrial
fibrillation was greater in patients with a previous history of atrial
fibrillatio