Scemblix Use In Pregnancy & Lactation

Treatment of women of childbearing potential/contraception: The pregnancy status of women of child-bearing potential should be verified prior to starting treatment with Scemblix.
Sexually active women of childbearing potential should use effective contraception (methods that result in less than 1% pregnancy rates) during treatment with Scemblix and for at least 3 days after the last dose.
Pregnancy: There are no studies in pregnant women therefore it is not possible to provide statements on a medicinal product-associated risk.
Animal reproduction studies in pregnant rats and rabbits demonstrated that oral administration of asciminib during organogenesis induced embryotoxicity, fetotoxicity and malformations (see Pharmacology: Toxicology: Preclinical data under Actions). Asciminib is not recommended during pregnancy and in women of childbearing potential who do not use contraceptives. If Scemblix is used during pregnancy or if the patient becomes pregnant during treatment with Scemblix, the patient must be informed of the potential risk to the foetus (see Precautions).
Breast-feeding: It is unknown whether asciminib or its metabolites are excreted in human milk following administration of Scemblix. There are no data on the effects of asciminib on the breast-fed infant or milk production.
Because of the potential for serious adverse effects in the breast-fed infant, breast-feeding is not recommended during treatment with Scemblix and for at least 3 days after the last dose.
Fertility: There are no data on the effects of Scemblix on human fertility.
In the rat fertility study asciminib did not affect reproductive function in male and female rats (see Pharmacology: Toxicology: Preclinical data: Fertility under Actions).