Relvar Ellipta Use In Pregnancy & Lactation

Pregnancy: Studies in animals have shown reproductive toxicity at exposures which are not clinically relevant (see Pharmacology: Toxicology: Preclinical safety data under Actions). There are no or limited data from the use of fluticasone furoate and vilanterol trifenatate in pregnant women.
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.
Breast-feeding: There is insufficient information on the excretion of fluticasone furoate or vilanterol trifenatate and/or metabolites in human milk. However, other corticosteroids and beta₂-agonists are detected in human milk (see Pharmacology: Toxicology: Preclinical 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 therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: There are no fertility data in humans. Animal studies showed no effect of fluticasone furoate/vilanterol trifenatate on fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).