Primary Hypercholesterolemia and Mixed Dyslipidemia

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 hyperlipidemia or mixed dyslipidemia.

Hypertriglyceridemia

Antara is also indicated as adjunctive therapy to diet for treatment of adult patients with 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 (eg, > 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.

Important Limitations of Use

Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus [see WARNINGS AND PRECAUTIONS].

General Considerations

Patients should be placed on an appropriate lipid-lowering diet before receiving Antara, and should continue this diet during treatment with Antara. Antara capsules can be given without regard to meals.

Patients should be advised to swallow Antara capsules whole. Do not open, crush, dissolve or chew capsules.

The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of Antara if lipid levels fall significantly below the targeted range.

Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 130 mg once daily.

Primary Hypercholesterolemia and Mixed Dyslipidemia

The initial dose of Antara is 130 mg per day.

Severe Hypertriglyceridemia

The initial dose is 43 to 130 mg per day. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 130 mg per day.

Impaired Renal Function

Treatment with Antara should be initiated at a dose of 43 mg per day in patients having mild to moderately impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. The use of Antara should be avoided in patients with severe renal impairment [see Use In Specific Populations and CLINICAL PHARMACOLOGY].

Geriatric Patients

Dose selection for the elderly should be made on the basis of renal function [see Use In Specific Populations and CLINICAL PHARMACOLOGY].

Dosage Forms And Strengths

• 43 mg capsules, imprinted with “43” and a segmented band, on the light green cap and “ANTARA” and “LUPIN” on the white to off-white body.
• 130 mg capsules, imprinted with “130” and a segmented band, on the dark green cap and “ANTARA” and “LUPIN” on the white body.

Storage And Handling

Antara (fenofibrate) Capsules, are available in two strengths:

43 mg capsules, imprinted with “43” and a segmented band, on the light green cap and “ANTARA” and “LUPIN” on the white to off-white body, available in bottles of 30 (NDC # 27437-109-06) and 100 (NDC # 27437-109-01).

130 mg capsules, imprinted with “130” and a segmented band, on the dark green cap and “ANTARA” and “LUPIN” on the white body, available in bottles of 30 (NDC # 27437-110-06) and 100 (NDC # 27437-110-01).

Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature] in a tightly closed container.

Distributed by: Lupin Pharma Baltimore, Maryland 21202 United States. Address Medical Inquiries to: Lupin Pharma Medical Inquiries 111 South Calvert Street, 21^st Floor Baltimore, MD 21202 or Call: 1-800-399-2561

Last reviewed on RxList: 1/10/2013
This monograph has been modified to include the generic and brand name in many instances.