Europe — EMA
Nustendi (Ezetimibe, Bempedoic Acid)
GNH USA supplies Nustendi (Ezetimibe / Bempedoic Acid), a combination lipid‑lowering agent for primary hyperlipidemia and cardiovascular risk reduction.
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What is Ezetimibe, Bempedoic Acid?
Ezetimibe, the active ingredient in Nustendi, is a combination lipid‑lowering agent presented as a tablet for oral use. It lowers cholesterol and triglyceride levels in adults with primary hyperlipidemia, particularly when diet and statin therapy alone are insufficient. GNH USA supplies Nustendi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
GNH USA supplies Nustendi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Ezetimibe, Bempedoic Acid used for?
Nustendi is indicated for disorders of lipid metabolism that require additional cholesterol reduction beyond statin therapy.
- Primary hyperlipidemia: provides additional lowering of LDL‑cholesterol when statins alone are inadequate. - Heterozygous familial hypercholesterolemia: helps achieve target LDL‑cholesterol levels in patients with this genetic condition. - Secondary prevention of cardiovascular disease: reduces LDL‑cholesterol as part of a comprehensive risk‑reduction strategy after myocardial infarction or stroke.
What are the side effects of Ezetimibe, Bempedoic Acid?
Adverse reactions reported with the ezetimibe/bempedoic acid combination are generally mild to moderate.
Common Side Effects: - Headache: mild, transient headache. - Muscle pain: occasional myalgia without significant CK elevation. - Gastrointestinal discomfort: nausea, abdominal pain or dyspepsia. - Elevated liver enzymes: mild, reversible increases in ALT/AST. - Fatigue: general tiredness reported by some patients.
Serious or Rare Side Effects: - Rhabdomyolysis: rare severe muscle breakdown, especially with concurrent statins. - Severe liver injury: uncommon but may present with jaundice or marked enzyme rise. - Allergic reactions: rash, pruritus, or angio‑edema in hypersensitive individuals. - Acute kidney injury: rare cases of renal function decline. - Tendon rupture: isolated reports in patients on concomitant statin therapy.
What precautions apply to Ezetimibe, Bempedoic Acid?
When prescribing Nustendi, clinicians should consider several safety aspects.
- Liver function monitoring: check ALT/AST before initiating therapy and periodically thereafter. - Statin co‑administration: assess risk of myopathy when used with high‑intensity statins. - Renal impairment: use caution in patients with severe kidney disease. - Pregnancy and lactation: avoid use unless benefits clearly outweigh risks. - Drug interactions: review concomitant medications for potential CYP or transporter effects. - Store at ambient temperature: keep below 25°C, retain original packaging, and protect from moisture.
What does Ezetimibe, Bempedoic Acid interact with?
Nustendi may interact with several drug classes; interactions are categorized by clinical relevance.
Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampicin): may reduce bempedoic‑acid exposure. - High‑intensity statins (e.g., rosuvastatin >20 mg): increase risk of myopathy.
Moderate Interactions (Monitor Closely): - Bile‑acid sequestrants: may lower ezetimibe absorption; separate dosing by at least 2 h. - Fibrates: additive risk of liver enzyme elevation. - Anticoagulants (warfarin): potential alteration of INR; monitor coagulation parameters. - Antidiabetic agents: monitor glucose control as lipid‑lowering may affect glycaemia.


