Bempedoic acid (Nilemdo) has been launched

Contraindications for Bempedoic Acid (Nilemdo)

Bempedoic acid (Nilemdo) is strictly contraindicated in the following situations: ①hypersensitivity to bempedoic acid or any excipient (e.g., lactose, microcrystalline cellulose); ②confirmed or suspected pregnancy, as animal studies suggest possible adverse effects on fetal development; ③concurrent use of simvastatin at doses exceeding 40 mg daily, because co-administration with high-dose simvastatin increases the risk of muscle toxicity (including rhabdomyolysis). In addition, although not explicitly contraindicated, patients with severe hepatic insufficiency or decompensated liver disease should avoid use, as the active substance requires hepatic metabolism for activation. For the above contraindications, patients must strictly follow the physician's judgment and must not decide on their own to initiate therapy. If allergic reactions (rash, pruritus, dyspnoea) occur or pregnancy is discovered during treatment, immediate discontinuation and urgent medical consultation are required.

Monitoring Considerations for Bempedoic Acid (Nilemdo)

Beyond routine precautions, physicians should pay particular attention to the following: ①Uric acid elevation and gout – bempedoic acid may inhibit renal uric acid excretion, leading to increased serum uric acid levels; therefore, patients with elevated baseline uric acid or a history of gout require close monitoring, with consideration of concomitant urate-lowering therapy if needed. ②Liver enzyme abnormalities – transient transaminase elevations may occur during treatment, usually without clinical symptoms, but if persistent and significant, dose reduction or discontinuation should be considered. ③Renal function monitoring – some patients may experience a mild decrease in glomerular filtration rate or a rise in serum creatinine, especially when co-administered with other drugs affecting renal function. It is recommended to check the above parameters at baseline and every 6 months thereafter. If patients develop symptoms suggestive of liver injury, such as fatigue, nausea, or jaundice, they should seek immediate medical attention. All monitoring measures are intended to maximise therapeutic benefit and minimise potential risks.

Use in Special Populations for Bempedoic Acid (Nilemdo)

Bempedoic acid (Nilemdo) is not indicated for children and adolescents under 18 years of age. To date, no clinical trial data are available for this age group, and its safety, efficacy, and long-term effects have not been established. Paediatric hypercholesterolaemia should generally be managed initially with lifestyle interventions (diet, exercise) and specialist care for familial hypercholesterolaemia, with drug therapy carefully selected from statins or ezetimibe, which have adequate paediatric evidence. Therefore, parents or guardians must not administer bempedoic acid (Nilemdo) to minors, even if their lipid levels are similar to those in adults. If an adolescent patient requires lipid-lowering therapy under special circumstances, the evaluation should be conducted by a paediatric endocrinologist or paediatric cardiologist, and an approved alternative agent should be chosen. The product packaging clearly states the age restriction, and prescribing physicians will strictly verify this.