Ultibro Breezhaler Use In Pregnancy & Lactation

Pregnancy: There are no data from the use of Ultibro Breezhaler in pregnant women available. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant exposures (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Indacaterol may inhibit labour due to a relaxant effect on uterine smooth muscle. Therefore, Ultibro Breezhaler should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus.
Breast-feeding: It is not known whether indacaterol, glycopyrronium and their metabolites are excreted in human milk. Available pharmacokinetic/toxicological data have shown excretion of indacaterol, glycopyrronium and their metabolites in the milk of lactating rats. The use of Ultibro Breezhaler by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Fertility: Reproduction studies and other data in animals do not indicate a concern regarding fertility in either males or females.