Europe — EMA
Nustendi (Ezetimibe, Bempedoic Acid)
GNH USA supplies Nustendi (Ezetimibe, Bempedoic Acid), a lipid‑lowering agent for primary hypercholesterolaemia and related disorders.
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What is Ezetimibe, Bempedoic Acid?
Ezetimibe, the active ingredient in Nustendi, is a lipid‑lowering agent presented as a tablet for oral use. It reduces cholesterol absorption and is used in adults with primary hypercholesterolaemia, often in combination with other therapies. GNH USA supplies Nustendi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and pharmacies worldwide.
What is Ezetimibe, Bempedoic Acid used for?
Nustendi combines two lipid‑modifying agents that act on cholesterol metabolism pathways. It is indicated for: - Primary hypercholesterolaemia: helps lower LDL‑cholesterol when diet and statins alone are insufficient. - Heterozygous familial hypercholesterolaemia (HeFH): provides additional LDL‑cholesterol reduction in genetically predisposed patients. - Statin‑intolerant patients: offers an alternative LDL‑cholesterol‑lowering option for those who cannot tolerate adequate statin doses.
What are the side effects of Ezetimibe, Bempedoic Acid?
Side‑effect profiles reflect the actions of both components.
Common Side Effects: - Gastrointestinal discomfort: mild abdominal pain or dyspepsia. - Elevated liver enzymes: transient increases in ALT/AST. - Muscle pain: mild myalgia without weakness. - Headache: occasional tension‑type headache. - Fatigue: general tiredness reported by some patients.
Serious or Rare Side Effects: - Rhabdomyolysis: severe muscle breakdown, especially with concurrent statins. - Acute liver injury: marked elevation of transaminases with jaundice. - Severe hypersensitivity: rash, angio‑edema or anaphylaxis. - Kidney impairment: acute renal failure in rare cases. - Hyperuricaemia: gout flares in predisposed individuals.
What precautions apply to Ezetimibe, Bempedoic Acid?
When prescribing Nustendi, clinicians should consider several safety aspects. - Liver function monitoring: check ALT/AST before initiation and periodically thereafter. - Statin co‑administration: assess risk of myopathy and adjust statin dose if needed. - Renal function: evaluate baseline creatinine in patients with chronic kidney disease. - Pregnancy and lactation: avoid use unless the potential benefit outweighs risk. - Drug interactions: review concomitant medications for CYP‑related effects. - Store at below 25°C: keep in the original container, protect from moisture and direct sunlight.
What does Ezetimibe, Bempedoic Acid interact with?
Nustendi may interact with several medicines that share metabolic pathways or affect muscle tissue.
Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine) may reduce bempedoic‑acid exposure. - High‑intensity statins (atorvastatin >40 mg) increase risk of rhabdomyolysis. - Cyclosporine: may raise ezetimibe concentrations.
Moderate Interactions (Monitor Closely): - Fibrates (gemfibrozil, fenofibrate) – additive risk of myopathy. - Warfarin – potential alteration of INR values. - Niacin – may increase flushing and liver enzyme changes.


