Trelegy Ellipta Use In Pregnancy & Lactation

Pregnant Women: There are no adequate and well-controlled studies with TRELEGY ELLIPTA or the individual components, fluticasone furoate, umeclidinium and vilanterol, in pregnant women. Corticosteroids and beta₂-agonists have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Because animal studies are not always predictive of human response, TRELEGY ELLIPTA should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Women should be advised to contact their physician if they become pregnant while taking TRELEGY ELLIPTA.
Use in Labour and Delivery: There are no adequate and well-controlled human studies that have investigated the effects of TRELEGY ELLIPTA or the individual components, fluticasone furoate, umeclidinium and vilanterol, during labour and delivery. Because beta-agonists may potentially interfere with uterine contractility, TRELEGY ELLIPTA should be used during labour only if the potential benefit justifies the potential risk.
Breast-feeding: It is not known whether fluticasone furoate, umeclidinium or vilanterol are excreted in human breast milk. However, other corticosteroids and beta₂-agonists have been detected in human milk.
Furthermore, other muscarinic antagonists (including metabolites) are excreted into the milk of lactating rats. A risk to breastfed newborns/infants cannot be excluded. Therefore, the use of TRELEGY ELLIPTA by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant.