Glycoair 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. Likewise there are no data from the use of either indacaterol or glycopyrronium in pregnant women.
No effects on the embryo or fetus were seen at any dose level during an inhalation embryo-fetal development study in rats. Indacaterol and glycopyrronium were not teratogenic in rats or rabbits following subcutaneous and inhalation administration respectively.
The potential risk for humans is unknown. Therefore as there is no adequate experience in pregnant women, it should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the fetus.
Clinical Considerations: Labor and delivery: Information related to indacaterol: Like other beta₂-adrenergic agonist containing drugs, Indacaterol may inhibit labor due to a relaxant effect on uterine smooth muscle.
Information related to glycopyrronium: In pregnant women undergoing Caesarean section, 86 minutes after a single intramuscular injection of 0.006 mg/kg glycopyrronium bromide, the concentration of glycopyrronium in the umbilical venous (0.28 (0.25) ng/mL) and in the umbilical arterial (0.18 (0.11) ng/mL) plasma were low (clinically insignificant).
Data: Animal data: Indacaterol: Adverse effects with respect to pregnancy and embryonal/foetal development in rabbits after subcutaneous administration, was only to be demonstrated at doses more than 500-fold than achieved following the daily inhalation of 150 microgram in humans (based on AUC0-24h).
Glycopyrronium: Glycopyrronium was not teratogenic in rats or rabbits following inhalation. Reproduction studies in rats and other data in animals did not indicate a concern regarding pre- and post-natal development. Glycopyrronium and its metabolites did not significantly cross the placental barrier of pregnant mice, rabbits and dogs. Published data for glycopyrronium in animals do not indicate any reproductive toxicity issues.
Lactation: It is not known whether indacaterol and/or glycopyrronium passes into human breast milk. There are no data on the effects of indacaterol and/or glycopyrronium on the breastfed child or on milk production. Indacaterol and glycopyrronium (including its metabolites) have been detected in the milk of lactating rats after subcutaneous and intravenous administration. Glycopyrronium reached up to 10- fold higher concentrations in the milk than in the blood of the dam after intravenous administration. Therefore the use of indacaterol/glycopyrronium 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: There are no special recommendations.
Infertility: Information related to indacaterol and glycopyrronium: Reproduction studies or other data in animals did not indicate a concern regarding fertility in either males or females.