Relvar Ellipta Use In Pregnancy & Lactation

Fertility: There are no fertility data in humans. Animal studies showed no effect of vilanterol or fluticasone furoate on fertility (see Pharmacology: Toxicology: Pre-clinical Safety Data under Actions).
Pregnancy: There has been limited pregnancy exposure in humans.
Animal studies have shown reproductive toxicity after administration of beta₂-agonists and corticosteroids (see Pharmacology: Toxicology: Pre-clinical Safety Data under Actions).
Administration of fluticasone furoate/vilanterol to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
Lactation: There is limited information on the excretion of fluticasone furoate or vilanterol or their metabolites in human milk. However, other corticosteroids and beta₂-agonists are detected in human milk (see Pharmacology: Toxicology: Pre-clinical Safety Data under Actions). A risk to breastfed newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue Fluticasone furoate + Vilanterol (as trifenatate) (Relvar Ellipta) therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.