Dosing and uses of Tricor, Lofibra tablets (fenofibrate)
Adult dosage forms and strengths
TriCor tablet
- 48mg
- 145mg
Lofibra tablet
- 54mg
- 160mg
Fenoglide tablet
- 40mg
- 120mg
Triglide tablet
- 160mg
Lipofen capsule
- 50mg
- 150mg
TriCor
Hypercholesterolemia, mixed dyslipidemia: Initially, 145 mg PO qDay
Hypertriglyceridemia: Initially, 48-145 mg PO qDay
Titrate q4-8week up to no more than 145 mg PO qDay
Triglide
Hypercholesterolemia, Mixed Dyslipidemia: initial 160 mg PO qDay
Hypertriglyceridemia: 50-160 mg PO qDay initially
Lipofen
Hypercholesterolemia, Mixed Dyslipidemia: initial 150 mg PO qDay
Hypertriglyceridemia: initial 50-150 mg PO qDay
Lofibra tablets
Hypercholesterolemia, Mixed Dyslipidemia: 160 mg PO qDay
Hypertriglyceridemia: 54-160 mg PO qDay
Fenoglide
Hypercholesterolemia, Mixed Dyslipidemia: 120 mg PO qDay
Hypertriglyceridemia: 40-120 mg PO qDay
Dosing Considerations
Overdose management
- Symptoms include GI distress
- Treatment is supportive
Dosing Modifications
Renal impairment
- TriCor (CrCl <50 mL/min): 48 mg/day initially; evaluate before increase dose
- Triglide: Initial, 50 mg/day
- Lipofen: Initial, no more than 50 mg/day
- Lofibra tablets: Initial, 54 mg/day
- Fenoglide: Initial, 40 mg/day
Administration
TriCor, Triglide, and Lofibra tablets can be taken without regard to meals
Lipofen: Take with meals
Pediatric dosage forms and strengths
Safety and efficacy not established
Geriatric dosage forms and strengths
TriCor
Hypercholesterolemia, mixed dyslipidemia, hypertriglyceridemia
Initial: 48 mg/day; evaluate before increase dose
Triglide
Hypercholesterolemia, mixed dyslipidemia, hypertriglyceridemia
Initial: 50 mg/day
Lipofen
Hypercholesterolemia, mixed dyslipidemia, hypertriglyceridemia
Initial: No more than 50 mg/day
Lofibra tablets
Hypercholesterolemia, mixed dyslipidemia, hypertriglyceridemia
Initial: 54 mg/day
Fenoglide
Hypercholesterolemia, mixed dyslipidemia, hypertriglyceridemia
Initial: 40 mg/day
Tricor, Lofibra tablets (fenofibrate) adverse (side) effects
>10%
Increased LFT's (dose related, 3-13%)
1-10%
Respiratory disorder (6%)
Abdominal pain (5%)
Back pain (3%)
CPK increased (3%)
Headache (3%)
Constipation (2%)
Nausea (2%)
Rhinitis (2%)
Postmarketing Reports
Muscle pain
Myopathies
Myositis
Diarrhea
Flatulence
Pancreatitis
Peptic ulcer
Cholelithiasis
CNS depression
Dysrhythmias
Peripheral vascular disease
Pulmonary embolus
Renal damage
Rash
Anemia
Leukopenia
Warnings
Contraindications
Known hypersensitivity
Severe renal impairment, including those with end-stage renal disease and those receiving dialysis
Active liver disease
Gallbladder disease
Nursing mothers
Cautions
Cholelithiasis reported with use; discontinue if gallstones detected upon gallbladder studies
Rare myopathy, myositis, or rhabdomyolysis reported with use; monitor
Increase in hepatic transaminases reported; discontinue if enzyme levels persist 3 times above the upper limit of normaL
Reversibly increases serum creatinine levels; consider monitoring renal function in patients at risk for renal impairment
Thrombocytopenia and agranulocytosis reported; monitor blood counts periodically during the first year of therapy
Associated with pulmonary embolism and deep venous thrombosis; use caution in patients with risk factors for VTe
Concomitant use with oral anticoagulants (monitor and adjust warfarin dose prn)
May further increase risk for rhabdomyolysis when added to optimal HMG-CoA reductase inhibitor regimen to further decrease TG and increase HDLs
Paradoxical decreases in HDL cholesterol (HDL-C) level reported
Rule out secondary causes of hyperlipidemia before initiating therapy
Withdraw therapy if no adequate response seen after 2-3 months
Use with caution in the elderly; dose adjustments may be necessary
Fenofibrate increases cholesterol excretion into bile, leading to risk of cholelithiasis; perform gallbladder studies if cholelithiasis suspected
Fibric acid derivatives as monotherapy or in combination with simvastatin have not been shown to significantly reduce cardiovascular mortality in major clinical studies
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown if excreted in breast milk; not recommended
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Tricor, Lofibra tablets (fenofibrate)
Mechanism of action
Increases VLDL catabolism, fatty acid oxidation, and elimination of triglyceride rich particles by enhancing synthesis of lipoprotein lipase, which in turn results in 30-60% decrease in total plasma triglycerides; HDL may increase modestly in some hypertriglyceridemic patients
Absorption
Bioavailability: 60-90%
Onset: 2 wk
Peak plasma time: 2-8 hr
Distribution
Distributes widely to most tissues
Protein bound: 99%
Metabolism
Liver
Metabolites: Fenofibric acid (active), fenofibric acid glucuronide (activity unknown)
Elimination
Half-life: 20 hr (10-35 hr range)
Dialyzable: No (HD)
Excretion: Urine (60-93%), feces (5-25%)
Pharmacogenomics
Genotyping patients with atherogenic dyslipidemia may establish who will benefit most from fenofibric acid therapy to increase HDL-C
Three single-nucleotide polymorphisms (SNPs) in the APOA5 region have been associated with increases in HDL-C
