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Pregnancy: No clinical data on exposed pregnancies in COPD patients are available. Studies in animals have shown reproductive toxicity associated with an increased incidence of 1 skeletal variation in rabbits (see Nonclinical Safety Data under Actions). The potential risk for humans is unknown. Because there are no adequate and well-controlled studies in pregnant women, indacaterol should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.
Labour and delivery: Like other beta2-adrenergic agonists, ONBREZ BREEZHALER may inhibit labor due to a relaxant effect on uterine smooth muscle.
Lactation: It is not known whether indacaterol passes into human breast milk. The substance has been detected in the milk of lactating rats. Because many drugs are excreted in human milk, as with other inhaled β2-adrenergic drugs, the use of Onbrez Breezhaler by breastfeeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant.
Females and males of reproductive potential: Reproduction studies or other data in animals did not reveal a problem or potential problem concerning fertility in either males or females.
