Minirin Use In Pregnancy & Lactation

Tablet/Melt oral lyophilisate: Fertility: Fertility studies have not been carried out. In vitro analysis of human cotyledon models have shown that there is no transplacental transport of desmopressin when administered at therapeutic concentrations corresponding to recommended dose.
Pregnancy: Data on a limited number (n = 53) of exposed pregnancies in women with diabetes insipidus as well as data on a limited number (n = 54) of exposed pregnancies in women with von Willebrand disease indicate no adverse effects of desmopressin on pregnancy or on the health of the foetus/newborn child. No other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Caution should be exercised when giving MINIRIN Melt/tablets to pregnant women.
Lactation: Results from analyses of milk from nursing mothers receiving high dose desmopressin (300 mcg intranasally), show that desmopressin is transferred to the milk but that the amount of desmopressin that can be transferred to the child is low and probably less than the amounts required to influence diuresis. Whether desmopressin will accumulate in breast milk upon repeated doses has not been studied.
Solution for injection: Pregnancy: Reproduction studies performed in rats and rabbits with doses more that 100 times the human dose have revealed no evidence of a harmful action of desmopressin on the foetus. One investigator has reported 3 cases of malformations in children to mothers suffering from diabetes insipidus and receiving desmopressin during pregnancy. However, several other published reports comprising more than 120 cases show that women treated with desmopressin during pregnancy have given birth to normal children. Furthermore a review of a very large data set identifying 29 children who have been exposed to desmopressin during the full pregnancy shows no increase in the malformation rate in the children born.
Lactation: Results from analyses of milk from nursing mothers receiving high dose desmopressin (300 µg intranasally), indicate that the amounts of desmopressin that may be transferred to the child are considerably less than the amounts required to influence diuresis or hemostasis.