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. |
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 | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TRILIPIX (TRILIPIX).
| Breastfeeding | Not recommended. M/P ratio unknown; fenofibric acid is excreted in rat milk; potential for serious adverse reactions in nursing infants. |
| 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 |
■ FDA Black Box Warning
There is no FDA-required black box warning for TRILIPIX.
| Serious Effects |
["Severe renal impairment (eGFR <30 mL/min/1.73 m²)","Active liver disease (including unexplained persistent liver function abnormalities)","Pre-existing gallbladder disease","Known hypersensitivity to fenofibric acid, fenofibrate, or any component of the formulation"]
| 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)"] |
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| 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. |