FENOFIBRIC ACID capsule, delayed release

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

CHOLINE FENOFIBRATE (UNII: 4BMH7IZT98) (FENOFIBRIC ACID - UNII:BGF9MN2HU1)

Доступна з:

Lupin Pharmaceuticals, Inc.

ІПН (Міжнародна Ім'я):

CHOLINE FENOFIBRATE

Склад:

FENOFIBRATE 45 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet to reduce triglycerides (TG) in patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibric acid delayed-release capsules therapy on reducing this risk has not been adequately studied. Fenofibric acid delayed-release capsules are 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 patients with primary hypercholesterolemia or mixed dyslipidemia. Fenofibrate at a dose equivalent to 135 mg of fenofibric acid delayed-release capsules did not reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1)] . Laboratory studies should be performed to establish that lipid levels are abnormal before instituting fenofibric acid delayed-release capsules therapy. Every reasonable attempt should be made to control serum lipids with non-drug methods including appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that may be contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (beta-blockers, thiazides, estrogens) should be discontinued or changed if possible, and excessive alcohol intake should be addressed before triglyceride-lowering drug therapy is considered. If the decision is made to use lipid-altering drugs, the patient should be instructed that this does not reduce the importance of adhering to diet. Drug therapy is not indicated for patients who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of VLDL. Fenofibric acid 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 (5.3)]. - patients with preexisting gallbladder disease [see Warnings and Precautions (5.5)]. - nursing mothers [see Use in Specific Populations (8.2)]. - patients with hypersensitivity to fenofibric acid or fenofibrate[see Warnings and Precautions (5.9)]. Risk Summary Limited available data with fenofibrate use in pregnant women are insufficient to determine a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no evidence of embryo-fetal toxicity was observed with oral administration of fenofibrate in rats and rabbits during organogenesis at doses less than or equivalent to the maximum recommended clinical dose of 135 mg daily, based on body surface area (mg/m2 ). Adverse reproductive outcomes occurred at higher doses in the presence of maternal toxicity (see Data). Fenofibric acid should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data: In pregnant rats given oral dietary doses of 14, 127, and 361 mg/kg/day from gestation day 6 to 15 during the period of organogenesis, no adverse developmental findings were observed at 14 mg/kg/day (less than the clinical exposure at the maximum recommended human dose [MRHD] of 300 mg fenofibrate daily, equivalent to 135 mg fenofibric acid daily, based on body surface area comparisons). Increased fetal skeletal malformations were observed at maternally toxic doses (361 mg/kg/day, corresponding to 12 times the clinical exposure at the MRHD) that significantly suppressed maternal body weight gain. 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, no adverse developmental findings were observed at 15 mg/kg/day (a dose that approximates the clinical exposure at the MRHD, based on body surface area comparisons). Aborted litters were observed at maternally toxic doses (≥ 150 mg/kg/day, corresponding to ≥ 10 times the clinical exposure at the MRHD) that suppressed maternal body weight gain. In pregnant rats given oral dietary doses of 15, 75, and 300 mg/kg/day from gestation day 15 through lactation day 21 (weaning), no adverse developmental effects were observed at 15 mg/kg/day (less than the clinical exposure at the MRHD, based on body surface area comparisons), despite maternal toxicity (decreased weight gain). Post-implantation loss was observed at ≥ 75 mg/kg/day (≥ 2 times the clinical exposure at the MRHD) in the presence of maternal toxicity (decreased weight gain). Decreased pup survival was noted at 300 mg/kg/day (10 times the clinical exposure at the MRHD), which was associated with decreased maternal body weight gain/maternal neglect. Risk Summary There is no available information on the presence of fenofibrate in human milk, effects of the drug on the breastfed infant, or the effects on milk production. Fenofibrate is present in the milk of rats, and is therefore likely to be present in human milk. Because of the potential for serious adverse reactions in breastfed infants, such as disruption of infant lipid metabolism, women should not breastfeed during treatment with fenofibric acid and for 5 days after the final dose [see Contraindications (4)] . The safety and effectiveness of fenofibric acid in pediatric patients have not been established. Fenofibric acid is substantially excreted by the kidney as fenofibric acid and fenofibric acid glucuronide, 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 fenofibric acid. The use of fenofibric acid should be avoided in patients who have 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 fenofibric acid has not been evaluated in subjects with hepatic impairment [see Contraindications (4) and Clinical Pharmacology  (12.3)].

Огляд продуктів:

Fenofibric acid delayed-release capsules are supplied in two dose strengths as follows: Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

Lupin Pharmaceuticals, Inc.
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Revised: 12/2023
Document Id: 574221bf-1643-4dd4-8ac6-29f387ce5eaf
34391-3
Set id: b9a3f97c-9e31-4a5f-822f-c9d45e394493
Version: 12
Effective Time: 20231208
Lupin Pharmaceuticals, Inc.

Характеристики продукта

FENOFIBRIC ACID- FENOFIBRIC ACID CAPSULE, DELAYED RELEASE
LUPIN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FENOFIBRIC ACID
DELAYED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
FENOFIBRIC ACID DELAYED-RELEASE CAPSULES.
FENOFIBRIC ACID DELAYED-RELEASE CAPSULES FOR ORAL USE
INITIAL U.S. APPROVAL: 2008
RECENT MAJOR CHANGES
Warnings and Precautions, Hepatotoxicity (5.2) 03/2021
INDICATIONS AND USAGE
Fenofibric acid delayed-release capsule is a peroxisome
proliferator-activated receptor (PPAR) alpha
agonist indicated as adjunctive therapy to diet to:
Reduce TG in patients with severe hypertriglyceridemia (1.1).
Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDLC in
patients with primary
hypercholesterolemia or mixed dyslipidemia (1.2).
Limitations of Use: Fenofibrate at a dose equivalent to 135 mg of
fenofibric acid delayed-release capsule
did not reduce coronary heart disease morbidity and mortality in
patients with type 2 diabetes mellitus
(5.1).
DOSAGE AND ADMINISTRATION
Hypertriglyceridemia: 45 to 135 mg once daily (2.2).
Primary hypercholesterolemia or mixed dyslipidemia: 135 mg once daily
(2.3).
Renally impaired patients: 45 mg once daily (2.4).
Maximum dose: 135 mg once daily (2.1).
May be taken without regard to food (2.1).
DOSAGE FORMS AND STRENGTHS
Oral Delayed-Release Capsules: 45 mg and 135 mg (3).
CONTRAINDICATIONS
Severe renal dysfunction, including patients receiving dialysis (4,
12.3).
Active liver disease (4, 5.2).
Gallbladder disease (4, 5.5).
Nursing mothers (4, 8.2).
Known hypersensitivity to fenofibric acid or fenofibrate (4, 5.9)
WARNINGS AND PRECAUTIONS
_Hepatotoxicity: _Serious drug-induced liver injury, including liver
transplantation and death, has been
reported with fenofibric acid. 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 o