Xcopri Use In Pregnancy & Lactation

Women of childbearing potential and contraception in males and females: Cenobamate is not recommended in women of childbearing potential not using contraception. Women of reproductive potential concomitantly using oral contraceptives should practice additional or alternative non-hormonal measures of birth control during treatment with cenobamate and until 4 weeks after treatment discontinuation (see Interactions).
Pregnancy: Risk related to epilepsy and antiepileptic medicinal products in general: It has been shown that in the offspring of treated women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3% in the general population. In the treated population, an increase in malformations has been noted with polytherapy; however, the extent to which the treatment and/or the underlying condition is responsible has not been elucidated. Discontinuation of antiepileptic treatments may result in exacerbation of the disease which could be harmful to the mother and the foetus.
Risk related to cenobamate: There are no adequate data from the use of XCOPRI in pregnant women.
Animal studies have shown that cenobamate crosses the placenta of rats. Studies in animals have shown reproductive toxicity at levels below clinical exposure (see Pharmacology: Toxicology: Preclinical safety data under Actions). XCOPRI should not be used during pregnancy unless the clinical condition of the woman requires treatment with cenobamate. Women of childbearing potential must use effective contraception during use of cenobamate and until 4 weeks after treatment discontinuation (see Interactions).
Breast-feeding: It is unknown whether cenobamate or its metabolites are excreted in human milk.
Studies in rats showed excretion of cenobamate in the maternal milk (see Pharmacology: Toxicology: Preclinical safety data under Actions). A risk to the suckling child cannot be excluded. As a precautionary measure, breast-feeding should be discontinued during treatment with XCOPRI.
Fertility: The effects of cenobamate on human fertility are unknown. Animal data are insufficient due to exposure below clinical levels (see Pharmacology: Toxicology: Preclinical safety data under Actions).