Revolade Use In Pregnancy & Lactation

Pregnancy: There are no or limited amount of data from the use of Revolade in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown.
Revolade is not recommended during pregnancy.
Women of childbearing potential/Contraception in males and females: Revolade is not recommended in women of childbearing potential not using contraception.
Breast-feeding: It is not known whether Revolade/metabolites are excreted in human milk. Studies in animals have shown that Revolade is likely secreted into milk (see Pharmacology: Toxicology: Preclinical safety data under Actions); therefore a risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to continue/abstain from Revolade therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: Fertility was not affected in male or female rats at exposures that were comparable to those in humans. However a risk for humans cannot be ruled out (see Pharmacology: Toxicology: Preclinical safety data under Actions).