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A synthetic steroid with antigonadotropic and antiestrogenic activity due to the suppression of the pituitary gland’s gonadotropic hormone and with androgenic effects (Sanofi 2017, AEMPS 2017). Used to treat endometriosis, fibrocystic breast disease, hereditary angioedema, mastalgia, premenstrual syndrome and menorrhagia. Administration orally twice a day.
Since the last update we have not found published data on its excretion in breastmilk or its effect on breastfed infants.
In the absence of data regarding protein binding and the volume of distribution, the known pharmacokinetic data (low molecular weight, high pKa and prolonged half-life) make it likely that it would transfer to milk in amounts which could be significant.
Because of its potential androgenic effect on the infant and prolactin inhibition, it should be avoided during breastfeeding (Hale 2019 p193, Sanofi 2017, AEMPS 2017, Briggs 2015) and replaced by known safe alternatives. (Yeich 2023, Bouillet 2015)