There are clear restrictions on the use of Alpelisib in patients with severe liver and kidney dysfunction and type 1 diabetes, and the drug regimen should be adjusted according to clinical risks. The following detailed instructions for contraindications include liver function, renal function damage and special precautions for patients with diabetes.

1. Patients with liver dysfunction

(1) Severe liver dysfunction

The pharmacokinetic data of aprepitil in patients with severe liver dysfunction (Child Pugh C grade) is insufficient, and its safety has not been established. Its use should be avoided. Mild to moderate damage (Child Pugh A/B grade) does not require dose adjustment, but adverse reactions need to be closely monitored.

Two patients with renal insufficiency

(1) Severe renal dysfunction

Patients with severe renal impairment and creatinine clearance rate (CLcr)<30mL/min lack pharmacokinetic data and are not recommended for use. Mild to moderate damage (CLcr30-90mL/min) does not require dose adjustment, but caution should be taken to increase the risk of adverse reactions such as hyperglycemia.

Patients with type 31 diabetes

(1) Absolute taboo

Apelix is prohibited for type 1 diabetes patients because it may cause severe hyperglycemia or even ketoacidosis. The SOLAR-1 trial has excluded such patients and there is a lack of safety data support in clinical practice.

(2) Type 2 diabetes management

Type 2 diabetes patients with good control need to strengthen blood glucose monitoring, and FPG should be tested weekly in the first 8 weeks. If FPG>250mg/dL or ketosis occurs, medication should be suspended. It is recommended that the endocrinology department consult and adjust the hypoglycemic plan.

4 Other taboo groups

(1) Pregnant women

Due to the risk of embryonic toxicity, it is prohibited during pregnancy. Women of childbearing age should take effective contraceptive measures during treatment and one week after the last dose, and confirm their pregnancy status before treatment.

(2) Lactating women

During breastfeeding, the use of aspirin is prohibited, and breastfeeding is not allowed within one week after the last dose. Medications may be secreted through breast milk and cause serious adverse reactions to infants.