GNH USA

Europe — EMA

Lipivim

GNH USA supplies Lipivim (Fenofibrate), a fibrate lipid‑lowering agent for hypertriglyceridemia, mixed dyslipidemia and primary hypercholesterolemia.

Fenofibrate Micronised

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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.

Frequently asked questions

What is Lipivim used for?+
Lipivim contains micronised fenofibrate and is indicated for the management of hypertriglyceridemia, mixed dyslipidemia, and as an adjunct to statin therapy in primary hypercholesterolemia when lipid targets are not achieved with statins alone.
How does fenofibrate work?+
Fenofibrate activates the nuclear receptor PPARα, which increases the transcription of genes involved in fatty‑acid β‑oxidation and decreases the synthesis of triglycerides. This results in enhanced clearance of triglyceride‑rich lipoproteins, modest reductions in LDL‑cholesterol, and a rise in HDL‑cholesterol.
What is the usual dose of Lipivim?+
The prescribed dose of Lipivim is determined by the treating physician based on the individual’s clinical condition, laboratory results and local labeling. The prescriber selects the appropriate strength and dosing schedule for each patient.
Is Lipivim safe in pregnancy or breastfeeding?+
Safety data for fenofibrate in pregnancy and lactation are limited. It should be used only if the potential benefit to the mother outweighs any possible risk to the fetus or infant, and the decision must be made by a qualified healthcare professional.
How do I order Lipivim from GNH USA?+
To request Lipivim, submit an enquiry on the product page at gnh-usa.com indicating the required quantity. GNH USA supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.
How does Lipivim compare with the main alternative drug class?+
The primary alternative for lipid management is the statin class, which lowers LDL‑cholesterol by inhibiting HMG‑CoA reductase. Fenofibrate, by contrast, primarily reduces triglycerides through PPARα activation. The two classes can be complementary, and clinicians may combine them when a broader lipid‑lowering effect is needed.
What are the storage and handling requirements for Lipivim?+
Lipivim should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original packaging, protect it from moisture and direct light, and ensure the container is tightly closed to maintain stability.
How is Lipivim administered?+
Lipivim is taken orally, usually with a meal to improve absorption. Tablets should be swallowed whole with a glass of water; they are not intended to be crushed, chewed, or dissolved.
What are the most serious risks associated with Lipivim?+
The most serious adverse events include rhabdomyolysis (severe muscle breakdown), significant liver injury, and severe hypersensitivity reactions such as anaphylaxis. Patients should promptly report unexplained muscle pain, dark urine, jaundice, or rash to their healthcare provider.
Who should not use Lipivim?+
Lipivim is contraindicated in patients with active liver disease, severe renal impairment, known hypersensitivity to fenofibrate or other fibrates, and in those taking contraindicated medicines such as gemfibrozil. Caution is also advised for individuals with a history of muscle disorders.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Fenofibrate Micronised
Route
Oral Use
Manufacturer
Vim Spectrum Srl
Origin
EU

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