Clascoterone (Winlevi®)

Pregnancy

There is no available data on the use of clascosterone in pregnant women that investigates the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

In animal reproduction studies, administration of clascoterone under the skin of pregnant rats and rabbits during the early pregnancy phase, at doses 8 or 39 times higher than the maximum recommended human dose, respectively, increased malformations in rats and post-implantation loss and resorptions in rabbits.

The risk of major birth defects and miscarriage for the indicated population is unknown.

To prevent the potential risk of clascoterone in pregnant women, it is not advised to use clascoterone during pregnancy until more data is available.

Be sure to talk to your doctor before using clascoterone when pregnant or planning to become pregnant.

Breastfeeding

There is no data regarding the presence of clascoterone or its metabolite in human milk, the effects on the breastfed infant, or milk production.

Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for clascoterone, as well as any potential adverse effects on the breastfed child from clascoterone treatment.