Fenofibrate (Page 3 of 7)

INDICATIONS AND USAGE

Treatment of Hypercholesterolemia

Fenofibrate Capsules, USP (micronized) is indicated as adjunctive therapy to diet for the reduction of LDL-C, total-C, triglycerides, and apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). 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

Fenofibrate Capsules, USP (micronized) 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 fenofibrate 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
IIa LDL C
IIb LDL, VLDL C TG
III (rare) IDL C, TG
IV VLDL TG ↑ ↔ C
V (rare) Chylomicrons, VLDL TG ↑ ↔
The NCEP Treatment Guidelines
Definite Atherosclerotic Disease * Two or More Other Risk Factors LDL-Cholesterol mg/dL (mmol/L)
Initiation Level Goal
*
Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease).
Other risk factors for coronary heart disease ( CHD) include: age (males: ≥45 years; females: ≥55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C <35 mg/dL (<0.91 mmol/L); and diabetes mellitus. Subtract I risk factor if HDL-C is ≥60 mg/dL (≥1.6 mmol/L).
In CHD patients with LDL-C levels 100 to 129 mg/dL, the physician should exercise clinical judgment in deciding whether to initiate drug treatment.
No No ≥190 ( ≥4.9) < 160 (<4.1)
No Yes ≥160 ( ≥4.1) < 130 (<3.4)
Yes Yes or No ≥130 ( ≥3.4) < 100 (<2.6)

CONTRAINDICATIONS

Fenofibrate capsules (micronized) is contraindicated in patients who exhibit hypersensitivity to fenofibrate.

Fenofibrate capsules (micronized) is contraindicated in patients with hepatic or severe renal dysfunction, including primary biliary cirrhosis, and patients with unexplained persistent liver function abnormality.

Fenofibrate capsules (micronized) is contraindicated in patients with preexisting gallbladder disease (see WARNINGS).

WARNINGS

Hepatotoxicity

Serious drug-induced liver injury (DILI), including liver transplantation and death, have been reported postmarketing with fenofibrate. DILI has been reported within the first few weeks of treatment or after several months of therapy and in some cases has reversed with discontinuation of fenofibrate treatment. Patients with DILI have experienced signs and symptoms including dark urine, abnormal stool, jaundice, malaise, abdominal pain, myalgia, weight loss, pruritus, and nausea. Many patients had concurrent elevations of total bilirubin, serum alanine transaminase (ALT), and aspartate transaminase (AST). DILI has been characterized as hepatocellular, chronic active, and cholestatic hepatitis, and cirrhosis has occurred in association with chronic active hepatitis.

In clinical trials, fenofibrate at doses equivalent to 134 mg to 200 mg fenofibrate daily, has been associated with increases in serum AST or ALT.

The incidence of increases in transaminases may be dose related.

Fenofibrate is contraindicated in patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities [see Contraindications (4)]. Monitor patient’s liver function, including serum ALT, AST, and total bilirubin, at baseline and periodically for the duration of therapy with fenofibrate. Discontinue fenofibrate if signs or symptoms of liver injury develop or if elevated enzyme levels persist (ALT or AST > 3 times the upper limit of normal, or if accompanied by elevation of bilirubin). Do not restart fenofibrate in these patients if there is no alternative explanation for the liver injury.

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