Lipantil Nano (Fenofibrate (Nanonised))

Fenofibrate acts on lipid metabolism pathways to lower abnormal blood fats.

• Hypertriglyceridaemia: reduces elevated triglyceride levels.
• Mixed dyslipidaemia: improves overall lipid profile by lowering triglycerides and modestly affecting cholesterol.
• Primary hypercholesterolaemia (adjunct therapy): assists statin therapy to further lower lipid concentrations.

• Fenofibrate activates peroxisome proliferator‑activated receptor alpha (PPARα) in hepatic cells, up‑regulating genes for fatty‑acid β‑oxidation and down‑regulating enzymes involved in triglyceride synthesis. This shift enhances fatty‑acid catabolism, reduces hepatic VLDL production, and increases clearance of triglyceride‑rich lipoproteins, resulting in lower plasma triglycerides and modest improvements in HDL‑cholesterol.

Fenofibrate may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

• Gastrointestinal discomfort: nausea, abdominal pain, or dyspepsia.
• Headache: mild to moderate intensity.
• Elevated liver enzymes: transient increase in ALT/AST.
• Muscle cramps: mild myalgia without weakness.
• Rash: mild skin irritation or itching.

Serious or Rare Side Effects

• Rhabdomyolysis: severe muscle breakdown with weakness and dark urine.
• Hepatotoxicity: significant liver injury with jaundice.
• Severe allergic reaction: anaphylaxis or angioedema.
• Gallstones: formation of biliary sludge or stones.
• Blood dyscrasias: thrombocytopenia or leukopenia.

When prescribing Fenofibrate, clinicians should consider several precautionary measures to minimise risk.

• Liver function monitoring: assess baseline and periodic ALT/AST levels.
• Renal function assessment: evaluate creatinine clearance before initiation.
• Muscle toxicity vigilance: advise patients to report unexplained muscle pain or weakness.
• Drug interactions review: avoid concomitant use with strong CYP2C8 inhibitors without dose adjustment.
• Pregnancy and lactation caution: use only if potential benefit outweighs risk, as safety data are limited.
• Store at ambient temperature: keep below 25 °C in the original container, protect from moisture and light.

Fenofibrate can interact with other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

• Gemfibrozil: combined use markedly increases risk of rhabdomyolysis.
• Strong CYP2C8 inhibitors (e.g., clopidogrel): may raise fenofibrate plasma levels.
• Anticoagulants (warfarin): may enhance anticoagulant effect, requiring INR monitoring.

Moderate Interactions (Monitor Closely)

• Statins (especially high‑dose simvastatin): increased risk of myopathy; monitor CK.
• Bile acid sequestrants: may reduce fenofibrate absorption; separate dosing by at least 1 hour.
• Immunosuppressants (e.g., cyclosporine): may affect lipid metabolism; monitor lipid levels.