Europe — EMA
Lipivim (Fenofibrate Micronised)
GNH USA supplies Lipivim (Fenofibrate), a fibrate lipid‑lowering agent for hypertriglyceridemia, mixed dyslipidemia and primary hypercholesterolemia.
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What is Fenofibrate Micronised?
Fenofibrate, the active ingredient in Lipivim, is a fibrate presented as a micronised oral formulation for oral use. It lowers elevated triglyceride concentrations and is employed in patients with hypertriglyceridemia, mixed dyslipidemia, or as adjunct therapy for primary hypercholesterolemia. The micronisation improves its dissolution rate, facilitating absorption after a meal.
GNH USA supplies Lipivim as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to WHO‑GMP standards and provides regulatory documentation to support importation.
What is Fenofibrate Micronised used for?
Fenofibrate is used to manage lipid disorders that involve elevated triglycerides and cholesterol. - Hypertriglyceridemia: reduces serum triglyceride levels and lowers risk of pancreatitis. - Mixed dyslipidemia: improves the overall lipid profile by decreasing triglycerides and modestly raising HDL‑cholesterol. - Primary hypercholesterolemia (adjunct): used together with statins to further lower LDL‑cholesterol when target levels are not achieved.
What are the side effects of Fenofibrate Micronised?
Fenofibrate may cause a range of adverse reactions, varying from mild to serious.
Common Side Effects: - Gastrointestinal discomfort: nausea, abdominal pain or dyspepsia. - Elevated liver enzymes: mild, transient increase in ALT or AST. - Muscle pain: myalgia without weakness. - Headache: mild to moderate intensity. - Elevated serum creatinine: mild rise in kidney function tests.
Serious or Rare Side Effects: - Rhabdomyolysis: severe muscle breakdown with possible renal failure. - Hepatotoxicity: marked elevation of liver enzymes or jaundice. - Severe allergic reactions: rash, angioedema or anaphylaxis. - Blood dyscrasias: thrombocytopenia or leukopenia. - Acute pancreatitis: rare but possible in severe hypertriglyceridemia.
What precautions apply to Fenofibrate Micronised?
Before prescribing fenofibrate, clinicians should consider several precautionary measures. - Liver function: assess baseline hepatic enzymes and monitor periodically. - Renal function: evaluate creatinine clearance, especially in patients with chronic kidney disease. - Muscle disorders: avoid in patients with a history of myopathy or concurrent statin therapy without monitoring. - Pregnancy and lactation: use only if potential benefit justifies potential risk; data are limited. - Drug interactions: review concomitant medications that may increase risk of myopathy or affect metabolism. - Store at ambient temperature: keep below 25 °C in the original container, protect from moisture and light.
What does Fenofibrate Micronised interact with?
Fenofibrate can interact with several medicines, altering efficacy or safety.
Major Interactions (Avoid): - Gemfibrozil: co‑administration markedly increases risk of rhabdomyolysis. - Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may raise fenofibrate plasma levels. - Warfarin: may potentiate anticoagulant effect, requiring INR monitoring.
Moderate Interactions (Monitor Closely): - Statins (especially high‑dose simvastatin): increased myopathy risk; dose adjustment may be needed. - Bile‑acid sequestrants (e.g., cholestyramine): may reduce fenofibrate absorption; separate dosing times. - Antidiabetic agents (e.g., sulfonylureas): fenofibrate can enhance hypoglycemic effect; monitor glucose.



