Onbrez Breezhaler Use In Pregnancy & Lactation

Pregnancy: Risk Summary: There are no adequate and well-controlled studies in pregnant women to inform a product-associated risk. There are no data from the use of indacaterol in pregnant women. Indacaterol was not teratogenic in rats or rabbits following subcutaneous administration.
The potential risk for humans is unknown. Therefore, indacaterol should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.
Clinical considerations: Labour and delivery: Like other beta₂-adrenergic agonists, indacaterol may inhibit labor due to a relaxant effect on uterine smooth muscle.
Data: Animal data: Adverse effects with respect to pregnancy and embryonal/foetal development in rabbits after subcutaneous administration, was only be demonstrated at doses more than 500-fold than achieved following the daily inhalation of 150 microgram in humans (based on AUC_0-24h).
Lactation: Risk Summary: It is not known whether indacaterol passes into human breast milk. There are no data on the effects of indacaterol on the breastfed child or on milk production. Indacaterol has been detected in the milk of lactating rats after subcutaneous administration. Because many drugs are transferred into human milk, as with other inhaled beta₂-adrenergic drugs, the use of Onbrez 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.
Females and males of reproductive potential: There are no special recommendations.
Infertility: Reproduction studies or other data in animals did not reveal a problem or potential problem concerning fertility in either males or females.