Fenofibrate

Current Lupin 48/145 mg tablets and Antara: reduce TG in adults with severe hypertriglyceridemia (TG ≥ 500 mg/dL); reduce LDL-C in adult primary hyperlipidemia when recommended LDL-C-lowering therapy is not possible. Current Amneal 54/160 mg tablets retain primary hypercholesterolemia/mixed-dyslipidemia lipid indications plus severe hypertriglyceridemia. Glenmark micronized capsules retain adult primary hypercholesterolemia/mixed dyslipidemia and hypertriglyceridemia (Fredrickson IV/V) indications. Do not substitute older broad indication wording for every product.

Address diet, alcohol, weight and secondary causes such as hypothyroidism, diabetes or TG-raising medicines first; improve glycemic control in diabetic fasting chylomicronemia before considering therapy. Fenofibrate did not reduce coronary morbidity/mortality in two large type 2 diabetes outcome trials. Very high TG increases pancreatitis risk, but fenofibrate’s effect on preventing pancreatitis is not established. This reference does not prescribe a guideline-based cardiovascular-risk algorithm.

All regimens below are once daily; strengths are not a universal conversion chart.

Lupin/Antara: eGFR 30 to < 60 mL/min/1.73 m² starts 48 mg/43 mg daily respectively; increase only after renal and TG evaluation. eGFR < 30, ESRD or dialysis is contraindicated. Amneal mild/moderate renal impairment starts 54 mg daily; avoid severe impairment. Glenmark renal impairment starts 67 mg/day; severe renal dysfunction is contraindicated. Glenmark specifically limits initial older-adult dose to 67 mg/day; other selected labels choose older-adult doses by renal function. Active hepatic disease is contraindicated; there is no validated hepatic dose-reduction algorithm.

Continue the lipid-lowering diet. Adjust using repeat lipids at 4–8 weeks; selected Lupin/Antara labels discontinue for inadequate response after 2 months. Amneal/Glenmark specify inadequate response after 2 months at maximum dose. Lupin tablets and Antara capsules must be swallowed whole, not crushed, broken, dissolved or chewed. Missed Lupin/Antara dose: resume at the next dose without an extra dose. Separate a bile-acid resin by at least 1 hour before or 4–6 hours after. Verify dispensing product rather than inferring bioequivalence from strength.

Severe renal impairment, active liver disease/persistent unexplained liver-test abnormalities, pre-existing gallbladder disease and product hypersensitivity. Current Lupin/Antara labels include fenofibric-acid/excipient allergy; Amneal also explicitly lists nursing mothers as contraindicated. Newer Lupin/Antara labels instead place lactation avoidance in section 8.2. Follow the exact label without treating that section-location difference as permission to breastfeed.

The selected current U.S. labels have no boxed warning. Serious liver injury, muscle injury, hypersensitivity and other precautions still apply.

Trial reactions include abnormal liver tests, increased ALT/AST/CK, abdominal pain, constipation and rhinitis. Postmarketing reports include serious hepatic/renal/muscle injury, pancreatitis, hypersensitivity, severe HDL reduction, photosensitivity and interstitial lung disease; reporting cannot establish frequency. Overdose requires medical/Poison Help guidance (U.S. 1-800-222-1222) and supportive care; there is no specific antidote, and high protein binding limits hemodialysis utility.

Human pregnancy data are insufficient; use only when potential benefit justifies fetal risk, with reassessment if pregnancy occurs. Animal reproductive findings do not quantify human risk. Selected Lupin/Antara labels advise no breastfeeding during treatment and for 5 days after the final dose because of potential serious infant effects; Amneal lists nursing as contraindicated. Human milk data are unavailable.

Pediatric safety/effectiveness is not established; no pediatric dose is supplied. Older adults require renal assessment and muscle-risk review. Glenmark micronized capsules explicitly start older adults at 67 mg daily; current Lupin/Antara/Amneal choose doses based on renal function. Avoid automatic full-dose substitution across these products.

Fenofibric acid is substantially renally eliminated; severe renal impairment increases exposure/accumulation and is contraindicated. Mild/moderate renal impairment needs reduced starting dose and monitored escalation. Hepatic-impairment PK has not been evaluated; active liver disease/persistent unexplained abnormalities are contraindicated rather than managed by a guessed dose percentage.

PPAR-alpha activation increases lipoprotein-lipase activity and reduces apoprotein C-III, promoting clearance of TG-rich particles. Changes in lipid measures do not prove improved clinical outcomes.

Activation / metabolism

Rapid ester hydrolysis to fenofibric acid, followed mainly by glucuronidation; parent drug is not detected in plasma.

Exposure / timing

Selected 48/145 mg tablet peak ~6–8 hours, active-metabolite half-life ~20 hours; Antara peak ~4–8 hours, half-life ~23 hours.

Binding / elimination

~99% protein bound; primarily urine as fenofibric acid/conjugate. Radiolabeled recovery ~60% urine and ~25% feces includes metabolites.

Product differences

Meals are required for selected 54/160 mg and conventional micronized capsules; selected 48/145 mg tablets and Antara permit dosing without food. These are product instructions, not mg-for-mg equivalence.

• Baseline lipid panel and secondary causes, renal function, ALT/AST/bilirubin; assess contraindications and all co-therapy.
• Repeat lipids at 4–8 weeks and assess response by 2 months; check HDL-C within first months.
• Periodic liver/renal testing; red/white blood counts during first 12 months. Check CK when muscle symptoms occur rather than relying on absence of symptoms.
• Frequent INR when coumarins are co-prescribed; review muscle, abdominal/biliary, allergic and thromboembolic symptoms.

Take the exact prescribed product with its meal directions and continue dietary therapy. Do not take an extra missed dose. Report muscle pain/weakness, dark urine, jaundice, severe abdominal pain or unusual bleeding promptly; airway swelling, severe rash or possible PE needs urgent care. Tell clinicians about fenofibrate before new medicines/dose changes. Discuss pregnancy and avoid breastfeeding as directed.

Lupin 145 mg tablet: white/off-white oval, LU / B22; example NDC 68180-389-09. Its label also lists 48 mg LU / B21. Imprint identification supplements dispensing records; it does not authorize substitution.

Lupin tablets: 25°C with excursions 15–30°C; protect from moisture. Antara: 25°C, excursions 15–30°C, tightly closed. Amneal: 20–25°C, protect from moisture, tight light-resistant child-resistant container. Glenmark micronized capsules: 20–25°C, protect from moisture, tight light-resistant child-resistant container. Keep securely away from children and use the dispensed container instructions.