Bezafibrate Sustained-Release Tablets are a prescription medicine mainly used for blood lipid regulation, indicated for a variety of hyperlipidemia types.

1. Indications: Which patients are suitable for bezafibrate?

1.1 Main Indication: Hyperlipidemia

(1) Bezafibrate Sustained-Release Tablets are indicated for the treatment of hyperlipidemia (including familial hyperlipidemia).

(2) It helps improve lipid metabolism disorders by reducing total cholesterol and triglycerides in serum, while increasing high-density lipoprotein cholesterol levels.

1.2 Prerequisite for Use: Administer only after confirmed diagnosis

(1) Before starting treatment, the diagnosis of hyperlipidemia must be confirmed by adequate blood tests.

(2) This medicine should only be considered on the basis of a definite diagnosis, to avoid unnecessary drug exposure and side effect risks.

2. Contraindications: Who must NOT use this medicine?

2.1 Contraindicated in patients with severe renal impairment

Bezafibrate is contraindicated in the following patients:

(1) Patients undergoing dialysis (including peritoneal dialysis).

(2) Patients with severe renal failure.

(3) Patients with serum creatinine ≥ 2.0 mg/dL.

(4) In these patients, impaired drug excretion can easily lead to drug accumulation, which may cause serious adverse reactions such as rhabdomyolysis.

2.2 Contraindicated in patients with a history of hypersensitivity

Patients with a history of hypersensitivity to bezafibrate or any of its ingredients must not use this medicine, to prevent severe reactions such as anaphylactic shock.

2.3 Contraindicated in pregnant women and women of childbearing potential

The safety of bezafibrate in pregnant women has not been established. Therefore, it is contraindicated in pregnant women or women who may become pregnant, to avoid potential harm to the fetus.

3. Use in Special Populations: Groups requiring extra caution

3.1 Patients with renal impairment (non‑contraindicated cases)

Special caution is required in patients with abnormal renal function but not meeting the contraindication criteria:

(1) Concomitant use with HMG‑CoA reductase inhibitors (statins) may increase the risk of rhabdomyolysis and should generally be avoided. If combination therapy is necessary, start at a low dose and closely monitor renal function and creatine kinase levels.

(2) Patients with serum creatinine > 1.5 mg/dL are at high risk even if they do not meet the contraindication criteria and should be treated with caution.

3.2 Patients with hepatic impairment

(1) Bezafibrate may increase plasma drug concentrations and raise the risk of liver injury in patients with hepatic dysfunction or a history of liver disease.

(2) Liver function should be monitored regularly during treatment. If abnormalities such as elevated transaminases occur, discontinue the drug promptly.

3.3 Elderly patients

Elderly patients often have decreased renal function; however, reduced muscle mass may cause serum creatinine to underestimate true renal function. Therefore:

(1) Treatment should start at a low dose, with dosage adjusted according to renal function.

(2) Renal function should be checked regularly during treatment to prevent adverse reactions caused by drug accumulation.

(3) Caution is needed regarding the risk of hypoglycemia when used concomitantly with sulfonylurea antidiabetic drugs.

3.4 Pediatric patients

There are no clinical study data in children; therefore, use in pediatric patients is not recommended.

3.5 Lactating women

(1) Animal studies have shown that bezafibrate is excreted in breast milk.

(2) Lactating women should, under medical supervision, decide whether to continue breastfeeding or discontinue the drug by balancing the therapeutic benefit and the benefits of breastfeeding.

3.6 Patients with cholelithiasis

Bezafibrate may promote gallstone formation in patients with cholelithiasis or a history of the disease. Use with caution and regular follow‑up is recommended.