Drug Detail:Fenofibric acid/fenofibrate (monograph) (Antara)
Drug Class:
Usual Adult Dose for Hyperlipidemia
Multiple products available:
1 capsule or tablet orally once a day (range: 90 to 200 mg per dose unit)
- Maximum dose: 1 tablet or capsule orally once a day
Some examples of branded tablets and capsules; multiple generics available:
- Antara (micronized capsules): 90 and 130 mg
- Lipofen (capsules): 150 mg
- Fenoglide (tablet): 120 mg
- Tricor (tablet): 145 mg
- Triglide (tablet): 160 mg
- Fenofibrate (micronized) capsules: 200 mg
Comments:
- Therapy should be withdrawn if inadequate response after 2 months of treatment.
- This drug is intended 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 (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia.
Uses: As an adjunct therapy to diet for the treatment of primary hypercholesterolemia and mixed dyslipidemia.
Usual Adult Dose for Hyperlipoproteinemia Type IIa (Elevated LDL)
Multiple products available:
1 capsule or tablet orally once a day (range: 90 to 200 mg per dose unit)
- Maximum dose: 1 tablet or capsule orally once a day
Some examples of branded tablets and capsules; multiple generics available:
- Antara (micronized capsules): 90 and 130 mg
- Lipofen (capsules): 150 mg
- Fenoglide (tablet): 120 mg
- Tricor (tablet): 145 mg
- Triglide (tablet): 160 mg
- Fenofibrate (micronized) capsules: 200 mg
Comments:
- Therapy should be withdrawn if inadequate response after 2 months of treatment.
- This drug is intended 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 (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia.
Uses: As an adjunct therapy to diet for the treatment of primary hypercholesterolemia and mixed dyslipidemia.
Usual Adult Dose for Hyperlipoproteinemia Type IIb (Elevated LDL + VLDL)
Multiple products available:
1 capsule or tablet orally once a day (range: 90 to 200 mg per dose unit)
- Maximum dose: 1 tablet or capsule orally once a day
Some examples of branded tablets and capsules; multiple generics available:
- Antara (micronized capsules): 90 and 130 mg
- Lipofen (capsules): 150 mg
- Fenoglide (tablet): 120 mg
- Tricor (tablet): 145 mg
- Triglide (tablet): 160 mg
- Fenofibrate (micronized) capsules: 200 mg
Comments:
- Therapy should be withdrawn if inadequate response after 2 months of treatment.
- This drug is intended 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 (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia.
Uses: As an adjunct therapy to diet for the treatment of primary hypercholesterolemia and mixed dyslipidemia.
Usual Adult Dose for Dyslipidemia
Multiple products available:
1 capsule or tablet orally once a day (range: 90 to 200 mg per dose unit)
- Maximum dose: 1 tablet or capsule orally once a day
Some examples of branded tablets and capsules; multiple generics available:
- Antara (micronized capsules): 90 and 130 mg
- Lipofen (capsules): 150 mg
- Fenoglide (tablet): 120 mg
- Tricor (tablet): 145 mg
- Triglide (tablet): 160 mg
- Fenofibrate (micronized) capsules: 200 mg
Comments:
- Therapy should be withdrawn if inadequate response after 2 months of treatment.
- This drug is intended 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 (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia.
Uses: As an adjunct therapy to diet for the treatment of primary hypercholesterolemia and mixed dyslipidemia.
Usual Adult Dose for Hyperlipoproteinemia Type IV (Elevated VLDL)
Dosing is product specific; available as micronized capsules, capsules, and tablets:
MICRONIZED CAPSULES:
- Antara: Initial dose: 30 to 90 mg orally once a day; maximum dose: 90 mg/day
- Antara: Initial dose: 43 to 130 mg orally once a day; maximum dose: 130 mg/day
- Fenofibrate: Initial dose: 67 to 200 mg orally once a day; maximum dose 200 mg/day
- Lipofen: Initial dose: 50 to 150 mg orally once a day; maximum dose: 150 mg/day
- Fenoglide: Initial dose: 40 to 120 mg orally once a day; maximum dose: 120 mg/day
- Tricor: Initial dose: 48 to 145 mg orally once a day: maximum dose 145 mg/day
- Fenofibrate: Initial dose: 54 to 160 mg orally once a day; maximum dose: 160 mg/day
- Triglide: 160 mg orally once a day; maximum dose: 160 mg/day
TITRATION: Individualize dose according to response and adjust as necessary following repeat lipid determinations at 4 to 8 week intervals; if lipid levels fall significantly, dose reduction should be considered.
Comments:
- Therapy should be withdrawn if inadequate response after 2 months of treatment with the maximum recommended dose.
Use: As an adjunct to diet for the treatment of severe hypertriglyceridemia.
Usual Adult Dose for Hyperlipoproteinemia Type V (Elevated Chylomicrons + VLDL)
Dosing is product specific; available as micronized capsules, capsules, and tablets:
MICRONIZED CAPSULES:
- Antara: Initial dose: 30 to 90 mg orally once a day; maximum dose: 90 mg/day
- Antara: Initial dose: 43 to 130 mg orally once a day; maximum dose: 130 mg/day
- Fenofibrate: Initial dose: 67 to 200 mg orally once a day; maximum dose 200 mg/day
- Lipofen: Initial dose: 50 to 150 mg orally once a day; maximum dose: 150 mg/day
- Fenoglide: Initial dose: 40 to 120 mg orally once a day; maximum dose: 120 mg/day
- Tricor: Initial dose: 48 to 145 mg orally once a day: maximum dose 145 mg/day
- Fenofibrate: Initial dose: 54 to 160 mg orally once a day; maximum dose: 160 mg/day
- Triglide: 160 mg orally once a day; maximum dose: 160 mg/day
TITRATION: Individualize dose according to response and adjust as necessary following repeat lipid determinations at 4 to 8 week intervals; if lipid levels fall significantly, dose reduction should be considered.
Comments:
- Therapy should be withdrawn if inadequate response after 2 months of treatment with the maximum recommended dose.
Use: As an adjunct to diet for the treatment of severe hypertriglyceridemia.
Usual Adult Dose for Hypertriglyceridemia
Dosing is product specific; available as micronized capsules, capsules, and tablets:
MICRONIZED CAPSULES:
- Antara: Initial dose: 30 to 90 mg orally once a day; maximum dose: 90 mg/day
- Antara: Initial dose: 43 to 130 mg orally once a day; maximum dose: 130 mg/day
- Fenofibrate: Initial dose: 67 to 200 mg orally once a day; maximum dose 200 mg/day
- Lipofen: Initial dose: 50 to 150 mg orally once a day; maximum dose: 150 mg/day
- Fenoglide: Initial dose: 40 to 120 mg orally once a day; maximum dose: 120 mg/day
- Tricor: Initial dose: 48 to 145 mg orally once a day: maximum dose 145 mg/day
- Fenofibrate: Initial dose: 54 to 160 mg orally once a day; maximum dose: 160 mg/day
- Triglide: 160 mg orally once a day; maximum dose: 160 mg/day
TITRATION: Individualize dose according to response and adjust as necessary following repeat lipid determinations at 4 to 8 week intervals; if lipid levels fall significantly, dose reduction should be considered.
Comments:
- Therapy should be withdrawn if inadequate response after 2 months of treatment with the maximum recommended dose.
Use: As an adjunct to diet for the treatment of severe hypertriglyceridemia.
Renal Dose Adjustments
Mild to moderate renal dysfunction: Initiate at lower doses and increase only after evaluating the effects of therapy on renal function and lipid levels:
- Antara (micronized capsules): Initial dose: 30 mg orally once a day; maximum dose: 90 mg orally once a day
- Antara (micronized capsules): Initial dose: 43 mg orally once a day; maximum dose: 130 mg orally once a day
- Fenofibrate (micronized capsules): Initial dose: 67 mg orally once a day; maximum dose: 200 mg orally once a day
- Fenofibrate (tablets): Initial dose: 54 mg orally once a day; maximum dose: 160 mg orally once a day
- Lipofen (capsules): Initial dose: 50 mg orally once a day; maximum dose: 150 mg orally once a day
- Fenoglide (tablets): Initial dose: 40 mg orally once a day; maximum dose: 120 mg orally once a day
- Tricor (tablets): Initial dose: 48 mg orally once a day; maximum dose: 145 mg orally once a day
Severe renal impairment: Contraindicated
Liver Dose Adjustments
Active liver disease: Contraindicated
- Monitor liver function tests, including serum ALT, AST, and total bilirubin; discontinue if signs or symptoms of liver injury develop or if elevated enzyme levels persist (ALT or AST greater than 3 times the upper limit of normal, or if accompanied by elevation of bilirubin
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 fenofibrate, fenofibric acid, or any product excipients
- Active liver disease including primary biliary cirrhosis and unexplained persistent liver function abnormalities
- Severe renal impairment, including dialysis
- Preexisting gallbladder disease
- Lactation
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Contraindicated
Other Comments
Administration advice:
- May be taken with food to increase absorption
- Swallow capsules and tablets whole; do not break, open, crush, dissolve, or chew
Concomitant use with bile acid binding resin:
- Take at least 1 hour before or 4 to 6 hours after bile acid binding resin
Storage requirements:
- Protect from light and moisture
- Triglide(R): Dispense in original bottle
General:
- Prior to initiating therapy, diseases contributing to hyperlipidemia should be assessed and adequately treated; medications associated with elevated triglycerides should be evaluated.
- In patients with type 2 diabetes showing fasting chylomicronemia, improving glycemic control may reduce fasting triglycerides and eliminate need for drug treatment.
- Initial treatment for dyslipidemia should be dietary specific targeted at the type of lipoprotein abnormality.
- This drug has not been shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus.
- Markedly elevated levels of serum triglycerides (e.g. greater than 2000 mg/dL) may increase the risk of developing pancreatitis; the effect of this drug on reducing this risk has not been adequately studied.
Monitoring:
- Hematologic: Monitor RBC and WBC counts periodically during the first 12 months of therapy
- Hepatic: Measure liver function at baseline and periodically during therapy
- Metabolic: Periodically measure lipid levels and adjust dose accordingly
- Renal: Monitor renal function in patients with renal impairment or those at risk for renal insufficiency (e.g., elderly)
- More frequent PT/INR monitoring until PT/INR stabilizes
Patient advice:
- Patients should be instructed to follow a lipid-modifying diet during therapy.
- Patients should be instructed to immediately inform their physician of symptoms of liver injury (e.g., jaundice, abnormal pain, nausea, malaise, dark urine, abnormal stool, pruritus); any muscle pain, tenderness, or weakness; onset of abdominal pain; or any other new symptoms.
- Patients should be instructed to notify their healthcare provider of all medications, supplements, and herbal preparations they are taking.
- Patients should be instructed to talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding; women should not breastfeed during treatment and for 5 days after the final dose.
