Trelegy Ellipta Use In Pregnancy & Lactation

Pregnancy: There are limited data from the use of fluticasone furoate/umeclidinium/vilanterol in pregnant women. Studies in animals have shown reproductive toxicity at exposures which are not clinically relevant (see Pharmacology: Toxicology: Pre-clinical safety data under Actions).
Administration of TRELEGY ELLIPTA to pregnant women should only be considered if the expected benefit to the mother justifies the potential risk to the foetus.
Breast-feeding: It is unknown whether fluticasone furoate, umeclidinium, vilanterol or their metabolites are excreted in human milk. However, other corticosteroids, muscarinic antagonists and 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 TRELEGY ELLIPTA 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 fluticasone furoate/umeclidinium/vilanterol on human fertility. Animal studies indicate no effects of fluticasone furoate, umeclidinium or vilanterol on male or female fertility (see Pharmacology: Toxicology: Pre-clinical safety data under Actions).