Seebri Breezhaler Use In Pregnancy & Lactation

Women of Childbearing Potential: There are no special recommendations for women of childbearing potential.
Fertility: Reproduction studies and other data in animals did not indicate a concern regarding fertility in either males or females (see Nonclinical Safety Data under Toxicology under Actions).
Pregnancy: No clinical data on exposed pregnancies in COPD patients are available. Seebri Breezhaler was not teratogenic in rats or rabbits following inhalational administration (see Nonclinical Safety Data under Toxicology under Actions). In human parturients undergoing caesarean section, 86 min after a single IM injection of 0.006 mg/kg glycopyrronium bromide, umbilical plasma concentrations were low. As there is no adequate experience in pregnant women, Seebri Breezhaler should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the fetus.
Breastfeeding: It is not known whether glycopyrronium bromide passes into human breast milk. However, glycopyrronium bromide (including its metabolites) was excreted into the milk of lactating rats. The use of Seebri Breezhaler by breastfeeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant (see Nonclinical Safety Data under Toxicology under Actions).