Trelegy Ellipta Use In Pregnancy & Lactation

Fertility: There are no data on the effects of Trelegy Ellipta on human fertility. Animal studies indicate no effects on male or female fertility (see PHARMACOLOGY: Toxicology: Preclinical Safety Data under Actions).
Use in Pregnancy: There are insufficient data from the use of Trelegy Ellipta in pregnant women. Animal studies have shown reproductive toxicity after administration of beta₂-agonists or corticosteroids (see PHARMACOLOGY: Toxicology: Preclinical Safety Data under Actions).
Trelegy Ellipta should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the foetus.
Use in 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 Trelegy Ellipta therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.