ANTARA- fenofibrate capsule

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

FENOFIBRATE (UNII: U202363UOS) (FENOFIBRIC ACID - UNII:BGF9MN2HU1)

Доступно од:

Lupin Pharmaceuticals, Inc.

INN (Међународно име):

FENOFIBRATE

Састав:

FENOFIBRATE 43 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Antara is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia. Antara is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g, > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus. [see Warnings and Precautions (5.1)]. Antara is contraindicated in: - patients with severe renal impairment, including those receiving dialysis [see Clinical Pharmacology (12.3)]. - patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities[see Warnings and Precautions (5.2)]. - patients with preexisting gallbladder disease [see Warnings and Precautions (5.5)]. - nursing mothers [see Use in Specific Populations (8.3)] . - patients with known hypersensitivity to fenofibric acid or fenofibrate[see Warnings and Precautions (5.9)]. Pregnancy Category: C Safety in pregnant women has not been established. There are no adequate and well controlled studies of fenofibrate in pregnant women. Fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In female rats given oral dietary doses of 15, 75, and 300 mg/kg/day of fenofibrate from 15 days prior to mating through weaning, maternal toxicity was observed at 0.3 times the maximum recommended human dose (MRHD), based on body surface area comparisons; mg/m2 . In pregnant rats given oral dietary doses of 14, 127, and 361 mg/kg/day from gestation day 6-15 during the period of organogenesis, adverse developmental findings were not observed at 14 mg/kg/day (less than 1 times the MRHD, based on body surface area comparisons; mg/m2 ). At higher multiples of human doses evidence of maternal toxicity was observed. In pregnant rabbits given oral gavage doses of 15, 150, and 300 mg/kg/day from gestation day 6 to 18 during the period of organogenesis and allowed to deliver, aborted litters were observed at 150 mg/kg/day (10 times the MRHD, based on body surface area comparisons; mg/m2 ). No developmental findings were observed at 15 mg/kg/day (at less than 1 times the MRHD, based on body surface area comparisons; mg/m2 ). In pregnant rats given oral dietary doses of 15, 75, and 300 mg/kg/day from gestation day 15 through lactation day 21 (weaning), maternal toxicity was observed at less than 1 times the MRHD, based on body surface area comparisons; mg/m2 . Fenofibrate should not be used in nursing mothers. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Safety and effectiveness have not been established in pediatric patients. Fenofibric acid is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Fenofibric acid exposure is not influenced by age. Since elderly patients have a higher incidence of renal impairment, dose selection for the elderly should be made on the basis of renal function [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3)].   Elderly patients with normal renal function should require no dose modifications. Consider monitoring renal function in elderly patients taking Antara. Fenofibrate should be avoided in patients with severe renal impairment [see Contraindications (4)]. Dose reduction is required in patients with mild to moderate renal impairment [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)]. Monitoring renal function in patients with renal impairment is recommended. The use of Antara has not been evaluated in subjects with hepatic impairment [see Contraindications (4) and Clinical Pharmacology (12.3) ].

Резиме производа:

Antara (fenofibrate) Capsules, are available in two strengths: Storage: Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [See USP Controlled Room Temperature] in a tightly closed container.

Статус ауторизације:

New Drug Application

Карактеристике производа

ANTARA- FENOFIBRATE CAPSULE
LUPIN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ANTARA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ANTARA.
ANTARA (FENOFIBRATE) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
RECENT MAJOR CHANGES
Warnings and Precautions, Hepatotoxicity (5.2) 06/2021
INDICATIONS AND USAGE
Antara is a peroxisome proliferator receptor alpha (PPARα) activator
indicated as an adjunct to diet:
to reduce elevated LDL-C, Total-C, triglycerides, and Apo B, and to
increase HDL-C in adult patients with
primary hypercholesterolemia or mixed dyslipidemia. (1.1)
to reduce triglyceride (TG) levels in adult patients with severe
hypertriglyceridemia. (1.2).
Important Limitations of Use: Fenofibrate was not shown to reduce
coronary heart disease morbidity and
mortality in patients with type 2 diabetes mellitus. (5.1).
DOSAGE AND ADMINISTRATION
Antara capsules can be taken without regard to meals (2.1).
Primary hypercholesterolemia and mixed dyslipidemia: 130 mg per day
(2.2)
Severe Hypertriglyceridemia: 43 to 130 mg per day; the dose should be
adjusted according to patient
response (2.3)
Renally impaired patients: Initial dose of 43 mg per day (2.4).
Geriatric patients: Select the dose on the basis of renal function
(2.5).
DOSAGE FORMS AND STRENGTHS
Oral capsules: 43 mg and 130 mg (3).
CONTRAINDICATIONS
Severe renal dysfunction, including patients receiving dialysis (4,
12.3)
Active liver disease (4, 5.3)
Gallbladder disease (4, 5.5)
Nursing mothers (4, 8.3)
Known hypersensitivity to fenofibrate (4, 5.9)
WARNINGS AND PRECAUTIONS
_Hepatotoxicity_ : Serious drug-induced liver injury, including liver
transplantation and death, has been
reported with Antara. Monitor patient's liver function, including
serum ALT, AST, and total bilirubin, at
baseline and periodically for the duration of therapy. Discontinue if
signs or symptoms of liver injury
develop or if elevated enzyme levels persist (5.2).
Myopathy and r