Lipidil Nt (Fenofibrate (Nanonised))

• Fenofibrate is indicated for several lipid disorders and is used as part of comprehensive lipid‑lowering therapy in adults with elevated triglycerides.
• Hypertriglyceridaemia: lowers serum triglyceride concentrations, helping to prevent pancreatitis and improve overall lipid profile.
• Mixed dyslipidaemia: reduces triglycerides, modestly raises HDL‑cholesterol and contributes to a more favorable total cholesterol/HDL ratio.
• Primary hypercholesterolaemia (adjunct): used alongside statins to further lower triglyceride‑rich lipoproteins and support cardiovascular risk management.
• Severe hypertriglyceridaemia: provides rapid and significant triglyceride reduction to lower the acute risk of pancreatitis.

• Fenofibrate activates peroxisome proliferator‑activated receptor‑alpha (PPARα), a nuclear transcription factor that regulates genes involved in fatty acid oxidation. Activation increases the catabolism of triglyceride‑rich lipoproteins, enhances lipoprotein lipase activity, and reduces hepatic production of very‑low‑density lipoprotein. It also down‑regulates apolipoprotein C‑III expression, which further promotes triglyceride clearance from the circulation.

Fenofibrate may be associated with a range of adverse reactions, varying from mild to serious.

Common Side Effects

• Gastrointestinal discomfort: nausea, abdominal pain or dyspepsia.
• Elevated liver enzymes: mild increases in ALT or AST.
• Muscle pain: myalgia without significant CK rise.
• Headache: mild to moderate intensity.
• Dizziness: occasional light‑headedness.
• Fatigue: general tiredness.

Serious or Rare Side Effects

• Rhabdomyolysis: severe muscle breakdown with marked CK elevation, potentially leading to renal failure.
• Severe hepatic injury: marked transaminase rise, jaundice or hepatic failure.
• Hypersensitivity reactions: rash, angioedema or anaphylaxis.
• Acute pancreatitis: rare but possible in patients with very high triglycerides.

When prescribing Fenofibrate, several precautions should be considered to minimize risk and ensure safe use.

• Liver function: assess baseline hepatic enzymes and monitor periodically.
• Renal function: adjust use in patients with severe renal impairment.
• Muscle disorders: avoid in patients with a history of myopathy or those on interacting statins.
• Pregnancy and lactation: use only if potential benefit justifies potential risk, as safety data are limited.
• Drug interactions: review concomitant medications for major interactions before initiating therapy.
• Store at ambient temperature: keep below 25 °C, in the original packaging, protected from moisture and light.

Fenofibrate can interact with several medicines, affecting its efficacy or safety profile.

Major Interactions (Avoid)

• Statins (especially high‑dose simvastatin): increased risk of myopathy and rhabdomyolysis.
• Cyclosporine: elevated fenofibrate plasma levels, enhancing toxicity.
• Anticoagulants (warfarin): potentiation of anticoagulant effect, requiring INR monitoring.

Moderate Interactions (Monitor Closely)

• Gemfibrozil: additive risk of muscle toxicity.
• Bile acid sequestrants: may reduce fenofibrate absorption, decreasing effectiveness.
• Thiazide diuretics: may increase serum uric acid, risking gout.
• Oral contraceptives: may slightly increase triglyceride levels, monitor lipid profile.