Antara (Fenofibrate) - Indications and Dosage

INDICATIONS AND USAGE

Treatment of Hypercholesterolemia

Antara is indicated as adjunctive therapy 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 (Fredrickson Types II a and II b). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below).

Treatment of Hypertriglyceridemia

Antara is also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). 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 Antara therapy on reducing this risk has not been adequately studied.

Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia.²

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, like thiazide diuretics and beta-blockers, is 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.

The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet (see WARNINGS and PRECAUTIONS).

Fredrickson Classification of Hyperlipoproteinemias

		Lipid Elevation
Type	Lipoprotein Elevated	Major	Minor
C=cholesterol
TG=triglycerides
LDL=low density lipoprotein
VLDL=very low density lipoprotein
IDL=intermediate density lipoprotein
I (rare)	Chylomicrons	TG	↑↔ C
II a	LDL	C	–
II b	LDL, VLDL	C	TG
III (rare)	IDL	C,TG	–
IV	VLDL	TG	↑↔ C
V (rare)	Chylomicrons, VLDL	TG	↑↔

NCEP Treatment Guidelines: LDL-C Goals and Cutpoints for Therapeutic Lifestyle Changes and Drug Therapy in Different Risk Categories

		LDL Level at
		Which to Initiate	LDL Level at
Risk	LDL Goal	Therapeutic Lifestyle	Which to Consider
Category	(mg/dL)	Changes (mg/dL)	Drug Therapy (mg/dL)
† CHD=coronary heart disease.
†† Some authorities recommend use of LDL-lowering drugs in this category if an LDL-C level of <100 mg/dL cannot be achieved by therapeutic lifestyle changes. Others prefer use of drugs that primarily modify triglycerides and HDL-C, e.g., nicotinic acid or fibrate. Clinical judgment also may call for deferring drug therapy in this subcategory.
††† Almost all people with 0-1 risk factor have 10-year risk <10%; thus, 10-year risk assessment in people with 0-1 risk factor is not necessary.
CHD† or CHD risk	<100	≥100	≥130
equivalents			(100-129:drug optional)††
(10-year risk >20%)
2+ Risk Factors	<130	≥130	10-year risk
(10-year risk ≤20%)			10-20%:≥130
			10-year risk
			<10%: ≥160
0-1 Risk Factor†††	<160	≥160	≥190
			(160-189: LDL-lowering
			drug optional)

After the LDL-C goal has been achieved, if the TG is still >200 mg/dL, non-HDL-C (total-C minus HDL-C) becomes secondary target of therapy. Non-HDL-C goals are set 30 mg/dL higher than LDL-C goals for each risk category.

DOSAGE AND ADMINISTRATION

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

For the treatment of adult patients with primary hypercholesterolemia or mixed hyperlipidemia, the initial dose of Antara is 130 mg per day.

For adult patients with 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.

Treatment with Antara should be initiated at a dose of 43 mg/day in patients having impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. In the elderly, the initial dose should likewise be limited to 43 mg/day.

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.

HOW SUPPLIED

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” with the Reliant logo on the white to off-white body, available in bottles of 30 (NDC # 67707-043-30) and 100 (NDC # 67707-043-99).

130 mg capsules, imprinted with “130” and a segmented band, on the dark green cap and “ANTARA” and ”OSCIENT” on the white body, available in bottles of 30 (NDC # 67707-130-30) and 100 (NDC # 67707-130-99).

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.