Pregnancy: There are no adequate data from the use of Enstilar in pregnant women. When administered orally in animals, studies of calcipotriol have not shown teratogenic effects, though reproductive toxicity has been shown (see Pharmacology: Toxicology: Preclinical safety data under Actions). Studies in animals with glucocorticoids have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions), but a number of epidemiological studies (less than 300 pregnancy outcomes) have not revealed congenital anomalies among infants born to women treated with corticosteroids during pregnancy. The potential risk for humans is uncertain.
Therefore, during pregnancy, Enstilar should only be used when the potential benefit justifies the potential risk.
Breast-feeding: Betamethasone passes into breast milk, but risk of an adverse reaction in the infant is very small with therapeutic doses. There are no data on the excretion of calcipotriol in breast milk. Caution should be exercised when prescribing Enstilar to women who breast-feed. The patient should be instructed not to use Enstilar on the breast when breast-feeding.
Fertility: Studies in rats with oral doses of calcipotriol or betamethasone dipropionate demonstrated no impairment of male and female fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions). There are no data on human fertility.