Breztri Aerosphere Use In Pregnancy & Lactation

Pregnancy: There are no adequate data on the use of BREZTRI AEROSPHERE in pregnant women.
Data on the use of inhaled budesonide in more than 2500 exposed pregnancies indicate no increased teratogenic risk associated with budesonide. Single-dose studies in humans found that very small amounts of glycopyrronium passed the placental barrier. There are no adequate data from use of formoterol or glycopyrronium in pregnant women.
No animal reproductive toxicology studies have been conducted with BREZTRI AEROSPHERE. Budesonide has been shown to induce embryofoetal toxicity in rats and rabbits, a class effect of glucocorticoids. At very high doses/systemic exposure levels, formoterol caused implantation losses as well as decreases in birth weight and early postnatal survival, whereas glycopyrrolate had no significant effects on reproduction (see Pharmacology: Toxicology: Preclinical safety data under Actions).
BREZTRI AEROSPHERE should only be used during pregnancy if the expected benefits outweigh the potential risks.
Breast-feeding: A clinical pharmacology study has shown that inhaled budesonide is excreted in breast milk. However, budesonide was not detected in nursing infant blood samples. Based on pharmacokinetic parameters, the plasma concentration in the child is estimated to be less than 0.17% of the mother's plasma concentration. Consequently, no effects due to budesonide are anticipated in breast-fed children whose mothers are receiving therapeutic doses of BREZTRI AEROSPHERE. It is not known whether glycopyrronium or formoterol are excreted in human milk. Evidence of transfer of glycopyrronium and formoterol into maternal milk in rats has been reported.
Administration of BREZTRI AEROSPHERE to women who are breast-feeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.
Fertility: Studies in rats have shown slight reductions in fertility only at dose levels higher than the maximum human exposure to formoterol (see Pharmacology: Toxicology: Preclinical safety data under Actions). Budesonide and glycopyrronium individually, did not cause any adverse effects on fertility in rats. It is unlikely that BREZTRI AEROSPHERE administered at the recommended dose will affect fertility in humans.