Anoro Ellipta Use In Pregnancy & Lactation

Pregnancy: There are no data from the use of umeclidinium/vilanterol in pregnant women. Studies in animals have shown reproductive toxicity at exposures which are not clinically relevant after administration of vilanterol (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Umeclidinium/vilanterol should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the foetus.
Breast-feeding: It is unknown whether umeclidinium or vilanterol are excreted in human milk. However, other beta₂-adrenergic agonists are detected in human milk. A risk to newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue umeclidinium/vilanterol therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: There are no data on the effects of umeclidinium/vilanterol on human fertility. Animal studies indicate no effects of umeclidinium or vilanterol on fertility.