Medical Information

Asciminib, as a novel kinase inhibitor targeting BCR-ABL1 protein, requires individualized medication plans based on physiological status and organ function differences for special populations. The following is a systematic explanation of medication precautions for seven categories of populations, including pregnancy and liver and kidney dysfunction.

1. Medication during pregnancy

(1) Animal studies have shown that it may cause structural abnormalities, death, or growth changes in embryos, and patients should be informed of potential risks to the fetus.

(2) Before treatment, it is necessary to confirm the pregnancy status, and effective contraceptive measures should be taken during the medication period and one week after discontinuation.

2. Medication during lactation

(1) Lack of drug metabolism data in human breast milk, breastfeeding should be avoided during treatment and one week after the last dose.

3. Fertility potential patients

(1) May impair female fertility, but it is not yet clear whether the impact is reversible.

(2) Before treatment, it is necessary to confirm the pregnancy status of the female, and continuous contraception is required during the medication period and one week after discontinuation.

4. Pediatric patients

(1) The safety and efficacy have not been established yet, and there are currently no clear medication recommendations.

5. Elderly patients

(1) There is no significant difference in safety and efficacy between patients aged 65 years or older and younger patients, and no special adjustments are needed.

6. Liver dysfunction

(1) Patients with mild to severe liver function impairment do not require dose adjustment, and changes in drug exposure have no clinical significance.

7. Renal insufficiency

(1) Patients with mild to severe kidney injury who do not require dialysis do not require dose adjustment, and there is a lack of data on end-stage renal disease patients.