Trelegy Ellipta Use In Pregnancy & Lactation

Fertility: There are no data on the effects of Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta) on human fertility. Animal studies indicate no effects on male or female fertility (see Pharmacology: Toxicology: Pre-clinical Safety Data under Actions).
Pregnancy: There are insufficient data from the use of Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta) in pregnant women. Animal studies have shown reproductive toxicity after administration of beta₂-agonists or corticosteroids (see Pharmacology: Toxicology: Pre-clinical Safety Data under Actions).
Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta) should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the foetus.
Lactation: It is unknown whether fluticasone furoate, umeclidinium, vilanterol or their metabolites are excreted in human milk. However, other corticosteroids, muscarinic antagonists and beta₂-agonists are detected in human milk. A risk to breast-fed newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta) therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.