Medical Information

Special attention should be paid to the risks of pregnancy and lactation, the impact on fertility, and the management of high blood sugar in elderly patients when using Alpelisib for special populations. Differentiated medication strategies should be adopted for different populations.

1. Pregnant women

(1) Apilis needs to be used in combination with Fluvistran, and pregnancy risks should refer to the Fluvistran instruction manual. Clinical confirmation of pregnancy requires testing, and women of childbearing age should strictly use contraception during treatment and one week after the last dose.

(2) Animal studies have shown that it may increase the risk of congenital heart disease in fetuses, and pregnant women should avoid using it. The background risk of major birth defects in the general population in the United States is 2% -4%, and the risk of miscarriage is 15% -20%.

2. Lactating women

(1) There is currently no data on the presence of drugs in human breast milk, but they may cause serious adverse reactions in infants. It is recommended to stop breastfeeding during the treatment period and within one week after the last dose.

(2) The breastfeeding information for the combined use of Fluvustat should be referred to separately from its instructions, and the risks of both should be evaluated in combination.

3. Male and female of childbearing age

(1) Women need to confirm their pregnancy status before treatment and use effective contraceptive measures until one week after the last dose. Men need to use condoms and other contraceptive methods.

(2) Animal studies have shown that it may impair fertility, and the risk of infertility should be fully communicated before treatment.

4. Pediatric patients

At present, safety and efficacy have not been established in pediatric patients, and there is a lack of clinical data to support pediatric medication.

5. Elderly patients

(1) The incidence of hyperglycemia is significantly increased in patients aged 75 and above (74% vs 66%), with a risk of grade 3-4 hyperglycemia reaching 56%. We need to strengthen blood glucose monitoring and intervention.

(2) The SOLAR-1 trial showed that elderly patients are more prone to adverse reactions such as dehydration and acute kidney injury.

6. Individuals with abnormal liver and kidney function

(1) Mild to moderate renal impairment (CLcr 30-90mL/min) does not require dose adjustment, while data for severe impairment (CLcr<30mL/min) is insufficient.

(2) The medication data for patients with liver function impairment is limited and requires careful evaluation. Severely injured individuals may need to adjust their dosage.