Usual Adult Dose for Hypertriglyceridemia

Capsules:

• Initial dose: 45 to 135 mg orally once a day
• Maximum dose: 135 mg once a day

• Initial dose: 35 to 105 mg orally per day
• Maximum dose: 105 mg once a day

• Dosages should be individualized according to patient response and if necessary, adjusted following repeat lipid determinations at 4 to 8 week intervals.
• Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
• Elevated triglycerides (TG) levels of 2000 mg/dL or higher may increase the risk of developing pancreatitis; the effect of therapy reducing this risk has not been adequately studied.

• As an adjunct to diet to reduce TG in patients with severe hypertriglyceridemia (500 mg/dL or greater)

Usual Adult Dose for Hyperlipidemia

Capsules:
135 mg orally once a day

Tablets:
105 mg orally once a day

Use: As an adjunct to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), TG, and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia.

Usual Adult Dose for Dyslipidemia

Capsules:
135 mg orally once a day

Tablets:
105 mg orally once a day

Use: As an adjunct to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), TG, and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia.

Renal Dose Adjustments

Capsules:

• Mild to moderate renal dysfunction: Initiate at 45 mg orally once a day; doses should be increased only after evaluation of the effects on renal function and lipid levels at this dose
• Severe renal dysfunction: Contraindicated

• Mild to moderate renal dysfunction: Initiate at 35 mg orally once a day; doses should be increased only after evaluation of the effects on renal function and lipid levels at this dose
• Severe renal dysfunction: Contraindicated

Liver Dose Adjustments

Active liver disease (including primary biliary cirrhosis and unexplained persistent liver function abnormalities): Contraindicated

Dose Adjustments

Elderly: Due to the higher incidence of renal impairment in this patient population, dose selection should be based on renal function; monitor renal function during therapy.

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to fenofibric acid or fenofibrate
• Active liver disease, including primary biliary cirrhosis and unexplained persistent liver function abnormalities
• Severe renal impairment, including those receiving dialysis
• Preexisting gallbladder disease
• Nursing mothers

Dialysis

Contraindicated

Other Comments

Administration advice:

• May be taken without regard to meals; swallow whole; do not open, crush, dissolve, or chew tablets or capsules
• Take at least 1 hour before or 4 to 6 hours after a bile acid resin
• Tablets: Therapy should be withdrawn in patients who do not have an adequate response after 2 months of treatment with the maximum dose of 105 mg/day

• Protect from light and moisture

• Patients should be placed on an appropriate lipid-lowering diet prior to receiving this drug and should continue this throughout treatment.
• Every attempt should be made to control serum lipids with non-pharmacologic methods prior to initiating drug therapy (e.g., diet, exercise, control of medical problems, dose reduction of medications known to exacerbate hypertriglyceridemia, etc.).
• Drug therapy is not indicated in patients with elevations of chylomicrons and plasma TG, but who have normal levels of very-low density lipoprotein (VLDL).

• Hematologic: Monitor RBC and WBC counts periodically during the first 12 months of therapy
• Metabolic: Lipid levels prior to initiating therapy and periodically during therapy; monitor HDL-C within the first few months of initiating therapy
• Renal: Monitor renal function periodically in patients with renal insufficiency
• Liver: Monitor liver function (ALT, AST, total bilirubin) at baseline, and periodically during therapy
• Musculoskeletal: Measure creatine phosphokinase levels as appropriate

• Patients should be advised to continue to follow an appropriate lipid-modifying diet.
• Patients should understand the potential risks of therapy and instructed to report unexplained muscle pain, tenderness, or weakness, especially if accompanied by malaise or fever; to report symptoms of liver injury such as jaundice, abdominal pain, or dark urine.
• Talk to your health care provider if you are pregnant, planning to become pregnant, or breastfeeding; patients should not breastfeed during treatment and for 5 days after the final dose.