ANTARA- fenofibrate capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lupin Pharmaceuticals, Inc.

INN (International Name):

FENOFIBRATE

Composition:

FENOFIBRATE 30 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

ANTARA® (fenofibrate) Capsules, 30 mg are size '4' capsules with opaque light green cap and opaque light green body, imprinted with LUPIN logo and "ANTARA"  in black ink on body, and "30" in black ink on cap, containing white to off-white pellets. NDC 27437 - 107 - 06                              30's Bottle ANTARA® (fenofibrate) Capsules, 90 mg are size '3' capsules with opaque dark green cap and opaque white body, imprinted with LUPIN logo and "ANTARA"  in black ink on body, and "90" in black ink on cap, containing white to off-white pellets. NDC 27437 - 108 - 06                              30's Bottle NDC 27437 - 108 - 09                              90's Bottle NDC 27437 - 108 - 01                              100's Bottle 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.

Authorization status:

New Drug Application

Summary of Product characteristics

ANTARA- FENOFIBRATE CAPSULE
LUPIN PHARMACEUTICALS, INC.
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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: 90 mg per day
(2.2).
Severe Hypertriglyceridemia: 30 to 90 mg per day; the dose should be
adjusted according to patient
response (2.3).
Renally impaired patients: Initial dose of 30 mg per day (2.4).
Geriatric patients: Select the dose on the basis of renal function
(2.5).
DOSAGE FORMS AND STRENGTHS
Oral capsules: 30 mg and 90 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 a