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. |
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 | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TRIGLIDE (TRIGLIDE).
| Breastfeeding | Fenofibrate is excreted in rat milk; no human data. M/P ratio unknown. Breastfeeding is contraindicated due to potential lipid metabolism disruption in infant and lack of safety data. |
| 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. |
■ 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 |
["Severe renal impairment (eGFR < 30 mL/min/1.73 m²)","Active liver disease including primary biliary cirrhosis and unexplained persistent liver function abnormalities","Known gallbladder disease","Hypersensitivity to fenofibrate or any component of the formulation","Nursing mothers (due to potential for tumorigenicity in animal studies)"]
| 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"] |
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| 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. |