Minirin Use In Pregnancy & Lactation

Pregnancy: Tablet & Oral lyophilisate: 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 bleeding complications indicate no adverse effects of desmopressin on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development.
Caution should be exercised when prescribing to pregnant women.
Fertility studies have not been done. In vitro analysis of human cotyledon models have shown that there is no transplacental transport of desmopressin when administered at therapeutic concentration corresponding to recommended dose.
Nasal spray: 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 doses.
Injection & Nasal spray: Published data on a limited number of exposed pregnancies in women with diabetes insipidus (n=53) as well as data on exposed pregnancies in women with bleeding complications (n=216) indicate no adverse effects of desmopressin on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development.
Caution should be exercised when prescribing MINIRIN to pregnant women.
Injection: Animal reproduction studies have shown no clinically relevant effects on parents and offspring. In vitro analysis of human cotyledon models have shown that there is no transplacental transport of desmopressin when administered at therapeutic concentration corresponding to recommended dose.
Lactation: Results from analyses of milk from nursing mothers receiving a high dose desmopressin acetate (300 microgram intranasally), indicate that the amounts of desmopressin that may be transferred to the child are considerably less than the amounts required to influence diuresis.
Nasal spray: Whether desmopressin will accumulate in breast milk upon repeated doses has not been studied.
Fertility: Injection: Studies with desmopressin in animals have shown no impairment of fertility in male and female rats.
Nasal spray: Fertility studies have not been carried out.