TRIGLIDE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRIGLIDE (TRIGLIDE).
TRIGLIDE (fenofibrate) is a peroxisome proliferator-activated receptor alpha (PPARα) activator. It increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apolipoprotein C-III.
| Metabolism | Fenofibrate is a prodrug that is rapidly hydrolyzed by esterases to the active metabolite fenofibric acid. Fenofibric acid is conjugated with glucuronic acid and excreted in urine. Major CYP450 involvement is minimal; however, fenofibric acid is a substrate of CYP3A4 and to some extent CYP2C8. |
| Excretion | Primarily renal (70% as unchanged drug), 20% fecal, <10% biliary. |
| Half-life | 22-35 hours; prolonged in renal impairment (up to 50 hours). |
| Protein binding | >99% to albumin. |
| Volume of Distribution | 0.11-0.16 L/kg; indicates limited extravascular distribution. |
| Bioavailability | 60-70% (oral). |
| Onset of Action | Oral: 2-4 hours for triglyceride reduction; peak effect at 4-8 weeks. |
| Duration of Action | 28-35 hours; sustained effect with daily dosing; lipid effects persist for weeks after discontinuation. |
| Molecular Weight | 436.5 |
Initial dose: 60 mg (1 tablet) twice daily, gradually increased over 3-7 days to maintenance dose of 120 mg twice daily.
| Dosage form | TABLET |
| Renal impairment | No specific dose adjustment for GFR >10 mL/min; avoid use in patients with GFR <10 mL/min or on dialysis. |
| Liver impairment | Contraindicated in Child-Pugh class B and C; use with caution in Child-Pugh class A with dose reduction (e.g., 60 mg twice daily) and monitor closely. |
| Pediatric use | Not approved for pediatric patients; safety and efficacy not established. |
| Geriatric use | Use lowest effective dose; monitor for cardiac and electrolyte disturbances; start at 60 mg twice daily and titrate slowly. |
| 1st trimester | Fetal risk cannot be ruled out. Animal studies have shown adverse effects, but no adequate human studies. Use only if potential benefit justifies risk. |
| 2nd trimester | Similar to first trimester; avoid use unless clearly needed. |
| 3rd trimester | May cause prolonged bleeding in mother and neonate due to antiplatelet effect; avoid near term. |
Clinical note
Comprehensive clinical and safety monograph for TRIGLIDE (TRIGLIDE).
| Placental transfer | Crosses placenta; measurable concentrations in fetal plasma. |
| Breastfeeding | Excreted into breast milk in low amounts; use with caution, especially in infants with thrombocytopenia or bleeding risks. |
| Lactation Rating |
■ FDA Black Box Warning
None
| Common Effects | Hypoglycemia low blood glucose level Dizziness Headache Nausea Vomiting Diarrhea Flatulence Bronchitis inflammation of the airways Anemia low number of red blood cells Edema swelling |
| Serious Effects |
Active pathological bleeding (e.g., peptic ulcer, intracranial hemorrhage)Hypersensitivity to TRIGLIDE or any componentSevere hepatic impairment (Child-Pugh Class C)
| Precautions | Hepatotoxicity: elevations in serum transaminases, rare reports of hepatitis and cirrhosis; monitor hepatic function, Cholelithiasis: increased cholesterol excretion into bile, risk of gallstone formation, Rhabdomyolysis: increased risk in patients with renal impairment, hypothyroidism, or those taking statins or other fibrates, Pancreatitis: observed in patients with severe hypertriglyceridemia, Renal impairment: contraindicated in severe renal disease; dose adjustment needed in mild-to-moderate impairment |
Loading safety data…
| L3 (Moderately Safe) |
| Teratogenic Risk | TRIGLIDE (fenofibrate) is contraindicated in pregnancy due to potential fetal harm. First trimester: no adequate human data; animal studies show embryotoxicity and delayed ossification at doses below human exposure. Second and third trimesters: risk of fetal skeletal abnormalities and growth retardation; use only if maternal benefit outweighs risk. |
| Fetal Monitoring | Monitor maternal liver function tests (AST, ALT), renal function (serum creatinine, BUN), and gallbladder ultrasound (increased risk of cholelithiasis). Fetal ultrasound for growth and anatomy if exposure occurs. |
| Fertility Effects | Animal studies show no significant fertility impairment; human data insufficient. Theoretical risk of hormonal disruption based on mechanism. |
| Food/Dietary |
| Take with food to enhance bioavailability. Avoid high-fat meals that may exacerbate hypertriglyceridemia. Limit alcohol intake as it can increase triglyceride levels and hepatotoxicity risk. Grapefruit juice has no significant interaction with fenofibrate. |
| Clinical Pearls | TRIGLIDE (fenofibrate) is a fibric acid derivative used as adjunctive therapy to diet for severe hypertriglyceridemia (≥500 mg/dL) to reduce risk of pancreatitis. Monitor renal function before initiation; dose adjustment required if eGFR 30-59 mL/min (starting dose: 48 mg/day). Avoid use if eGFR <30 mL/min or active liver disease. Coadministration with statins increases risk of myopathy/rhabdomyolysis; discontinue if unexplained muscle pain or weakness occurs. |
| Patient Advice | Take with meals to improve absorption and reduce gastrointestinal side effects. · Report unexplained muscle pain, tenderness, or weakness immediately, especially if also taking a statin. · Avoid alcohol consumption as it can worsen triglyceride levels and liver function. · You may need regular blood tests to monitor kidney function, liver enzymes, and lipid levels. · Do not take if you have severe kidney disease or active liver disease. |