TRICOR
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRICOR (TRICOR).
Tricor (fenofibrate) activates peroxisome proliferator-activated receptor alpha (PPARα), leading to increased lipolysis and clearance of triglyceride-rich lipoproteins, and reduced hepatic VLDL secretion. It also increases HDL cholesterol synthesis.
| Metabolism | Primarily hepatic metabolism via glucuronidation (UGT1A1, UGT1A3, UGT2B7); also via CYP3A4 and CYP2C8 to a lesser extent. |
| Excretion | Renal: approximately 60% as fenofibric acid and its glucuronide conjugate; fecal: approximately 25% |
| Half-life | Terminal elimination half-life of fenofibric acid is approximately 20 hours (range 10-27 hours). Clinical context: supports once-daily dosing; steady state achieved within 5-7 days. |
| Protein binding | Approximately 99% bound to albumin. |
| Volume of Distribution | 0.9 L/kg, indicating extensive tissue distribution. |
| Bioavailability | Oral: approximately 81% (Tricor tablets) under fed conditions; food significantly increases absorption. |
| Onset of Action | Oral: significant reduction in triglycerides and LDL-cholesterol observed within 2 weeks. |
| Duration of Action | Duration of lipid-lowering effect persists throughout the 24-hour dosing interval. Maximal effect achieved by 4-8 weeks. |
| Molecular Weight | 360.83 |
Oral: 48 mg to 145 mg once daily, taken with meals. For hypertriglyceridemia: 48 to 145 mg/day; for severe hypertriglyceridemia: start 48 mg/day and titrate to 145 mg/day. For mixed dyslipidemia: 145 mg once daily.
| Dosage form | TABLET |
| Renal impairment | GFR 30-59 mL/min: dose reduction required, maximum 48 mg/day. GFR <30 mL/min or dialysis: contraindicated. Not recommended for use in severe renal impairment. |
| Liver impairment | Child-Pugh Class A: caution, no specific dose adjustment defined. Child-Pugh Class B or C: contraindicated due to risk of accumulation. |
| Pediatric use | Not approved for pediatric use in the US. In adolescents (10-16 years) with severe hypertriglyceridemia, limited data: start 48 mg/day; may increase to 145 mg/day after 8 weeks if triglycerides remain elevated. Use only if potential benefit outweighs risk. |
| Geriatric use | Start at low end of dosing range (48 mg/day) due to age-related renal function decline. Monitor renal function regularly. Maximum dose 145 mg/day if GFR ≥60 mL/min. |
| 1st trimester | Teratogenic effects not observed in animal studies; limited human data. Avoid use unless benefit outweighs risk. |
| 2nd trimester | Fetal risk cannot be ruled out due to lack of adequate human studies. Use only if clearly needed. |
| 3rd trimester | May cause neonatal complications if used near term; avoid use in third trimester unless essential. |
Clinical note
Comprehensive clinical and safety monograph for TRICOR (TRICOR).
| Placental transfer | Crosses placenta in animal studies; human data limited but transfer likely occurs. |
| Breastfeeding | Excreted into breast milk in small amounts; use caution due to potential for serious adverse effects in nursing infants. Consider alternative therapies. |
| Lactation Rating |
■ FDA Black Box Warning
None
| Serious Effects |
Severe renal impairment (eGFR <30 mL/min/1.73 m2)Active liver disease including primary biliary cirrhosisPre-existing gallbladder diseaseKnown hypersensitivity to fenofibrate or any component
| Precautions | Hepatotoxicity: Monitor liver enzymes; discontinue if enzyme levels persist >3 times ULN, Cholelithiasis: Increased cholesterol saturation of bile; contraindicated in gallbladder disease, Pancreatitis: Risk with severe hypertriglyceridemia or during therapy, Myopathy/Rhabdomyolysis: Increased risk when combined with statins, especially in renal impairment or elderly, Renal impairment: Dose adjustment required (contraindicated if CrCl <30 mL/min), Venous thromboembolism: Potential increased risk |
| Food/Dietary | TRICOR should be taken with meals to enhance absorption. Grapefruit juice may increase drug levels; avoid excessive consumption. A high-fat meal can increase absorption by 35%. Avoid high-fat and high-carbohydrate meals that can elevate triglycerides. Alcohol consumption should be minimized or avoided. |
Loading safety data…
| L3 (Moderately Safe) |
| Teratogenic Risk | FDA Pregnancy Category C. First trimester: No adequate studies; animal studies show fetal toxicity (skeletal malformations, growth retardation) at doses 1-2 times human exposure. Second and third trimesters: Potential risk of fetal harm; use only if maternal benefit outweighs risk. Avoid in severe maternal cholestasis due to drug accumulation. |
| Fetal Monitoring | Monitor maternal liver function, creatinine, glucose, and lipid profile regularly. Fetal ultrasound for growth restriction and skeletal development if used in pregnancy. Assess for maternal hepatotoxicity and rhabdomyolysis. |
| Fertility Effects | No human data. In animal studies, fenofibrate reduced fertility indices and increased estrous cycle length at high doses. Theoretical risk of hormonal disruption due to PPARα activation. |
| Clinical Pearls | TRICOR (fenofibrate) is a fibric acid derivative used to lower triglycerides and increase HDL. It is not first-line for LDL reduction. Monitor renal function as dose adjustment is needed in CKD. Avoid coadministration with statins in patients with renal impairment due to increased risk of rhabdomyolysis. May cause reversible increases in serum creatinine and homocysteine. Contraindicated in severe renal impairment (eGFR <30 mL/min/1.73m²), active liver disease, and gallbladder disease. Can increase the effect of oral anticoagulants, requiring INR monitoring. |
| Patient Advice | Take TRICOR with meals to reduce gastrointestinal side effects. · Avoid alcohol while on this medication as it may worsen triglyceride levels and increase liver enzyme abnormalities. · Report unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or malaise. · Do not take this medication if you have severe kidney disease, liver disease, or gallbladder disease. · Use effective contraception if you are of childbearing age as TRICOR may cause fetal harm. · Regular blood tests are required to monitor kidney and liver function as well as lipid levels. · Inform all healthcare providers you are taking TRICOR, especially before surgery or any new medication. · Take exactly as prescribed; do not double doses if you miss one. |