Laos Lucius version of Asimini for special populations

1. Pregnancy

According to the results of animal studies and the mechanism of action, Asciminib can cause embryo-fetal injury when administered to pregnant women. There are no available data on the use of Asciminib in pregnant women to assess drug-related risks.

Animal reproduction studies in pregnant rats and rabbits have shown that oral administration of asciminil during organogenesis induces structural abnormalities, embryo-fetal mortality, and growth changes.

Inform pregnant women and women of reproductive potential about the potential risks to the fetus.

2. Lactation

There are no data on the presence of Asciminib or its metabolites in human milk, its effects on breastfed children, or milk production.

Due to the possibility of serious adverse effects in breastfed infants, women are advised not to breastfeed during treatment with Asciminib and for 1 week after the last dose.

3. Males and females of reproductive potential

According to the results of animal studies, Asciminib can cause embryo-fetal injury when administered to pregnant women [see "Use in specific populations"].

Verify the gestational status of females of reproductive potential before initiating Asciminib treatment.

During treatment with Asciminib and for 1 week after the last dose, women of reproductive potential should use an effective method of contraception.

According to the results of animal studies, Asciminib may impair fertility in women of reproductive potential. The reversibility of this effect on fertility is unknown.

4. Children's medication

The safety and efficacy of Asciminib in pediatric patients have not been determined.

5. Medication for the elderly

Overall, no difference in the safety or efficacy of Asciminib was observed in patients aged 65 years and older compared to younger patients. The number of patients aged 75 years and older was insufficient to assess whether there was a difference in safety or efficacy.

6. Renal impairment

For patients with mild to severe renal impairment (estimated glomerular filtration rate [eGFR] 15 to 89 mL/min/1.73 m2) who do not require Asciminib dialysis, no dose adjustment is required.

7. Liver damage

Dose adjustment is not required for patients with mild [total bilirubin≤ upper limit of normal (ULN) and aspartate aminotransferase (AST) > ULN or total bilirubin > 1 to 1.5 times ULN and any AST] to severe hepatic impairment (total bilirubin > 3 times ULN and any AST) treated with Asciminib.