Valdoxan Use In Pregnancy & Lactation

Effects on fertility: Oral reproductive toxicity trials with agomelatine in rats showed no effect on fertility at plasma exposures of 60-100-fold human exposure at the maximal recommended clinical dose. No effect of agomelatine on juvenile rat behavioural performances, visual and reproductive function were observed. There were mild non dose dependent decreases in body weight and food intake, delayed preputial separation and decreased long bone growth related to the pharmacological properties and some minor (reversible) effects (e.g., decreased prostate weight with atrophy/decreased amount of seminal fluid, decreased weight of testis) on male reproductive tract without any impairment on reproductive performances.
Use in pregnancy: Animal trials do not indicate direct or indirect harmful effects with respect to pregnancy, embryofoetal development, parturition or postnatal development at systemic exposures (plasma AUC) of 100-fold or greater the human exposure at the maximal recommended clinical dose. Agomelatine and/or its metabolites passes into the placenta and foetuses of pregnant rats. No clinical data on exposed pregnancies are available. As a precautionary measure, it is recommended to avoid the use of agomelatine during pregnancy.
Use in lactation: It is not known whether agomelatine and/or its metabolites are excreted into human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of agomelatine/metabolites in milk. There were no adverse effects on offspring following oral administration of agomelatine to rats from prior to mating until weaning, with systemic exposures (plasma AUC) of 100-fold human exposure at the maximal recommended clinical dose. The effects of agomelatine on the nursing infant have not been established. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from agomelatine therapy following consideration of the relative benefits of breast feeding for the child and of therapy for the woman.