TRILIPIX
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRILIPIX (TRILIPIX).
TRILIPIX (fenofibric acid) is a peroxisome proliferator-activated receptor alpha (PPARα) agonist. It increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase, and reduces production of apoprotein C-III.
| Metabolism | Fenofibric acid is primarily metabolized via glucuronidation. It is not metabolized by cytochrome P450 (CYP) enzymes. |
| Excretion | Primarily renal excretion as glucuronide conjugate and unchanged drug; ~60% of dose excreted in urine as fenofibric acid and its glucuronide, ~25% in feces. |
| Half-life | Terminal elimination half-life of fenofibric acid is approximately 20 hours (range 10-35 hours), allowing once-daily dosing. |
| Protein binding | Fenofibric acid is highly bound to plasma albumin (>99%). |
| Volume of Distribution | Apparent volume of distribution (Vd/F) is approximately 0.9 L/kg, indicating distribution into extracellular fluid. |
| Bioavailability | Absolute bioavailability of fenofibric acid from TRILIPIX is not determined; relative bioavailability compared to micronized fenofibrate is approximately 100% after oral administration. |
| Onset of Action | Significant reduction in triglycerides and increase in HDL-C observed within 2-4 weeks after oral administration. |
| Duration of Action | Duration of lipid-lowering effect persists with continued once-daily dosing; effects may wane within weeks after discontinuation. |
| Molecular Weight | 360.83 |
135 mg orally once daily, not to exceed 135 mg/day.
| Dosage form | CAPSULE, DELAYED RELEASE |
| Renal impairment | Contraindicated in severe renal impairment (eGFR <30 mL/min/1.73 m²). For mild to moderate impairment (eGFR 30-59 mL/min/1.73 m²), maximum dose is 67 mg daily. |
| Liver impairment | Contraindicated in Child-Pugh Class B and C hepatic impairment. No dose adjustment specified for Child-Pugh Class A; use with caution. |
| Pediatric use | Safety and efficacy not established in pediatric patients. |
| Geriatric use | No specific dose adjustment recommended; select dose cautiously due to age-related renal function decline. |
| 1st trimester | Studies in animals have shown teratogenic effects (reduced fetal weight, delayed ossification, visceral/skeletal malformations) at doses similar to human exposure. No adequate human studies. Increased risk of congenital anomalies cannot be excluded. |
| 2nd trimester | Animal studies show fetotoxicity and reduced fetal growth. No controlled human studies. Use only if potential benefit justifies potential risk to fetus. |
| 3rd trimester | Fenofibrate may cross placenta and accumulate in fetal tissues. Risk of neonatal complications (e.g., prolonged labor, hemorrhage) due to effects on prostaglandin synthesis. Avoid in third trimester unless clearly needed. |
Clinical note
Comprehensive clinical and safety monograph for TRILIPIX (TRILIPIX).
| Placental transfer | Fenofibrate crosses placenta in rats (high concentrations). Human data limited, but likely due to molecular weight (360.83 g/mol) and lipophilicity. Expected to cross human placenta. |
| Breastfeeding |
■ FDA Black Box Warning
There is no FDA-required black box warning for TRILIPIX.
| Serious Effects |
Severe hepatic impairment (Child-Pugh class B or C)Severe renal impairment (eGFR < 30 mL/min/1.73 m²)Active gallbladder disease (known or suspected cholelithiasis)Hypersensitivity to fenofibrate or any excipientNursing mothers (due to potential risk to infant)
| Precautions | Risk of myopathy/rhabdomyolysis, especially in patients with renal impairment or those taking statins, Elevations in serum transaminases, possibly leading to cholelithiasis, Hepatocellular and obstructive jaundice have been reported, Monitor renal function prior to and during therapy, Not recommended in patients with severe renal impairment (eGFR <30 mL/min/1.73 m²) |
| Food/Dietary | Avoid high-fat meals during administration as they can alter fenofibric acid absorption. Avoid grapefruit juice as it may increase drug exposure. Alcohol consumption should be limited (no more than 1 drink per day for women, 2 for men) due to potential hepatotoxicity and worsening of hypertriglyceridemia. |
Loading safety data…
| Fenofibrate is excreted into rat milk at high concentrations. No human data; theoretical risk of serious adverse reactions in nursing infants (e.g., hepatic effects, interference with triglyceride metabolism). Decision to discontinue breastfeeding or drug should consider importance of drug to mother. |
| Lactation Rating | L4 (Limited Safety Data - Potential Risk) |
| Teratogenic Risk | Pregnancy category C. First trimester: No adequate studies in humans; animal studies show fetal toxicity at high doses. Second and third trimesters: Use only if benefit outweighs risk; may cause fetal harm due to maternal hypertriglyceridemia or drug effects. |
| Fetal Monitoring | Monitor maternal lipid profile, liver function, renal function, and blood glucose. Fetal monitoring via ultrasound if used in pregnancy. |
| Fertility Effects | Fenofibrate may reduce fertility; animal studies show reversible effects on spermatogenesis and estrous cycle. |
| Clinical Pearls | TRILIPIX (fenofibric acid) is a fibric acid derivative used as an adjunct to diet for severe hypertriglyceridemia. Monitor renal function prior to initiation and periodically; dose reduction required for eGFR 30-59 mL/min/1.73m². Contraindicated in severe renal impairment (eGR <30) and active liver disease. May increase serum creatinine; typically reversible. Co-administration with statins increases risk of myopathy/rhabdomyolysis; avoid in patients with predisposing factors. Not recommended for primary prevention of coronary heart disease. |
| Patient Advice | Take TRILIPIX with or without food, but avoid taking with a high-fat meal as it may increase absorption variability. · Report unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or malaise. · Inform your healthcare provider if you have kidney disease, liver disease, or a history of gallbladder problems. · Do not take this medication if you are pregnant or breastfeeding without consulting your doctor. · Alcohol consumption should be minimized or avoided as it can increase triglyceride levels and liver stress. |