FENOGLIDE
Clinical safety rating
cautionComprehensive clinical and safety monograph for FENOGLIDE (FENOGLIDE).
Comprehensive clinical and safety monograph for FENOGLIDE (FENOGLIDE).
Primary hypercholesterolemiaMixed dyslipidemiaSevere hypertriglyceridemia
Fenofibrate is a peroxisome proliferator-activated receptor alpha (PPARα) agonist. It increases lipolysis and elimination of triglyceride-rich particles from plasma, reduces hepatic production of VLDL, and increases HDL cholesterol.
| Metabolism | Hepatic metabolism via glucuronidation; minor CYP450 involvement (CYP3A4). |
| Excretion | Fenoglide (fenofibrate) is primarily excreted in urine as fenofibric acid and its glucuronide conjugate, accounting for approximately 60-70% of the dose. About 20-25% is eliminated in feces via biliary excretion. Renal excretion is the major route. |
| Half-life | The terminal elimination half-life of fenofibric acid is approximately 20 hours (range 15-25 hours). This long half-life allows once-daily dosing. Steady-state is reached within approximately 5 days. |
| Protein binding | Fenofibric acid is extensively bound to plasma proteins, primarily albumin, with a binding rate greater than 99%. |
| Volume of Distribution | The apparent volume of distribution (Vd) of fenofibric acid is approximately 0.9 L/kg. This suggests distribution into total body water, with some tissue binding. |
| Bioavailability | The absolute oral bioavailability of fenofibric acid from fenofibrate tablets is approximately 90% under fed conditions. Administration with food increases absorption by up to 35% compared to fasting. |
| Onset of Action | After oral administration, significant reductions in triglycerides and LDL-C may be observed within 2 to 4 weeks, with maximal effects by 4 to 8 weeks. There is no immediate clinical effect. |
| Duration of Action | The lipid-lowering effect persists throughout the 24-hour dosing interval with once-daily dosing. The duration correlates with the half-life; effects diminish over several days after discontinuation. |
| Molecular Weight | 390.44 |
160 mg orally once daily, taken with or without food.
| Dosage form | TABLET |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment (eGFR >30 mL/min/1.73 m2). Not recommended in severe renal impairment (eGFR <30 mL/min/1.73 m2) or dialysis. |
| Liver impairment | Contraindicated in severe hepatic impairment (Child-Pugh class C). Use caution in moderate impairment (Child-Pugh class B); consider dose reduction. |
| Pediatric use | Not approved for use in pediatric patients under 18 years of age. |
| Geriatric use | No specific dose adjustment; monitor renal function due to age-related decline. |
| 1st trimester | Contraindicated; increased risk of fetal malformations, especially neural tube defects and cardiovascular anomalies. |
| 2nd trimester | Contraindicated; may cause fetal bone marrow depression and increased risk of hemorrhage. |
| 3rd trimester | Contraindicated; may cause fetal bone marrow depression and increased risk of hemorrhage. |
Clinical note
Comprehensive clinical and safety monograph for FENOGLIDE (FENOGLIDE).
| Placental transfer | Crosses placenta extensively; fetal concentrations reach maternal levels. |
| Breastfeeding | Excreted into breast milk; potential for serious adverse reactions in nursing infants including bone marrow suppression. Use is contraindicated. |
| Lactation Rating | L5 |
| Teratogenic Risk | First trimester: No adequate studies; animal data show no major malformations at clinically relevant doses. Second and third trimesters: Associated with adverse maternal and fetal outcomes (e.g., preterm birth, low birth weight) due to β-receptor agonist effects. Avoid use during pregnancy. |
| Fetal Monitoring | Monitor maternal heart rate, blood pressure, serum glucose, and potassium. Fetal monitoring for signs of distress (e.g., tachycardia, growth restriction). Assess for preterm labor symptoms. |
| Fertility Effects | No known direct effects on fertility in humans. Animal studies show no impaired fertility at clinically relevant doses. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
Hypersensitivity to fenoglide or any componentPregnancyLactationPre-existing bone marrow depressionActive infection
| Precautions | Hepatotoxicity: rare but severe; monitor liver enzymes., Rhabdomyolysis: risk increased with renal impairment, hypothyroidism, statins., Renal function: dose adjustment needed in mild-moderate impairment; contraindicated in severe renal disease., Cholelithiasis: fenofibrate increases cholesterol excretion into bile., Pancreatitis: associated with severe hypertriglyceridemia; monitor triglycerides., Venous thromboembolism: increased risk with fenofibrate. |
| Food/Dietary | Take with food to enhance absorption. Avoid high-fat meals immediately before or after dose. Grapefruit juice may increase fenofibrate exposure (moderate interaction, monitor). Statin co-administration: avoid large amounts of grapefruit juice. |
| Clinical Pearls | Fenofibrate is a fibric acid derivative used primarily for hypertriglyceridemia and mixed dyslipidemia. It activates PPAR-alpha, increasing lipoprotein lipase and reducing apolipoprotein C-III. Monitor renal function; dose adjustment required for CrCl 30-60 mL/min. Contraindicated in severe renal impairment (CrCl <30) and active liver disease. Can increase serum creatinine, but this is often reversible. Co-administration with statins increases risk of myopathy, especially in elderly or renal impairment. May increase homocysteine levels; monitor if at risk for thrombosis. |
| Patient Advice | Take with food to improve absorption. · Avoid alcohol as it may worsen triglyceride levels. · Report unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or malaise. · Do not stop medication without consulting your doctor, even if you feel well. · Keep all appointments for blood tests to monitor liver function and lipid levels. |
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