This drug is an oral ATP citrate lyase inhibitor and belongs to a new type of lipid-lowering drug.

1、 Drug name

1. Product Name: ネセトール ® (Nexletol)

2. Common name: Bempedoic Acid

3. Dosage form: Film coated tablets

2、 Indications

1. Hypercholesterolemia.

2. Familial hypercholesterolemia.

3、 Specifications and characteristics

1. Specification: 180mg/tablet.

2. Appearance: Oval shaped film coated tablets ranging from white to slightly yellow white.

4、 Main components

1. Active ingredient: Bempedoic Acid 180mg.

5、 Usage and dosage

Regular dosage: Adults take 180mg once a day orally.

6、 Dose adjustment

If used in combination with HMG CoA reductase inhibitors (statins) or if the patient has renal dysfunction, although there is no need to adjust the dosage, relevant monitoring should be strengthened.

7、 Medication precautions

1. Dosage: This product is not affected by diet and can be taken before or after meals.

2. Administration method: The entire tablet must be swallowed. If it is packaged in PTP, it should be taken out of the PTP aluminum foil plate before consumption to prevent esophageal damage caused by ingestion.

3. Handling of missed doses: It is recommended that if missed doses are taken, they should be replenished as soon as possible; But if it is close to the next medication time, the missed dose should be skipped and the regular medication plan should be resumed. It is not allowed to take double the dose at once.

8、 Medication for special populations

1. Pregnant women and women who may become pregnant: Do not use. Animal experiments have shown fetal toxicity (skeletal abnormalities) and developmental effects after birth. Effective contraceptive measures must be taken during the medication period and at least one week after discontinuation.

2. Breastfeeding women: It is recommended to stop breastfeeding. Drugs can be secreted through human breast milk.

3. Children: Safety has not been established yet (no clinical data available).

4. Elderly: No special restrictions, use according to regular dosage.

5. Patients with liver dysfunction:

Severe (Child Pugh C grade): may cause an increase in blood drug concentration and should be used with caution.

Mild to moderate (Child Pugh A/B grade): No dose adjustment required.

6. Patients with renal insufficiency:

Mild to moderate: No need to adjust dosage.

Patients with severe and end-stage renal disease undergoing dialysis: Although there is no need to adjust the dosage, the increased drug exposure requires close observation of efficacy and safety.

Gout or hyperuricemia patients: There is a risk of deterioration and close monitoring of serum uric acid levels is necessary.

9、 Adverse reactions

1. Common adverse reactions (incidence rate 1%~5%): hyperuricemia, gout, joint pain, muscle pain, muscle spasms, anemia, decreased hemoglobin, abnormal liver function, elevated liver enzymes (AST/ALT), elevated blood creatinine, elevated blood urea, decreased glomerular filtration rate.

Incidence rate ≥ 5%: limb pain.

2. Serious risks to be aware of:

Rhabdomyolysis: Especially when combined with statins, the risk increases and CK values need to be monitored regularly.

Hyperuricemia/worsening of gout: Regular testing of serum uric acid is required.

Hepatotoxicity: Regular monitoring of liver function is necessary.

10、 Contraindications

1. Individuals with a history of allergies to the ingredients of this medication.

2. Pregnant or potentially pregnant women.

11、 Drug interactions

1. Statins: This product can significantly increase the blood concentrations of simvastatin, pravastatin, rosuvastatin, and atorvastatin. When used in combination, close monitoring of symptoms of rhabdomyolysis such as muscle pain and CK values is necessary.

2. Probenecid: can increase the blood concentration of beperidone.

3. Yizhemai Bu: It can increase the blood concentration of Yizhemai Bu and its metabolites.

4. Oral contraceptives: can increase the blood concentration of norgestrel.

5. Other: No clinically significant interaction was observed with metformin.

12、 Storage method

1. Store at room temperature.

2. The validity period is 48 months.

13、 Manufacturer

Otsuka Pharmaceutical Co., Ltd

Nexletolinformation