Animal reproduction studies were conducted with the individual components of this drug, tiotropium bromide and olodaterol. There are no adequate and well-controlled human studies that have investigated the effects of this drug on preterm labor or labor at term, and in pregnant women.

Tiotropium:
No structural abnormalities were seen with inhaled tiotropium at doses 8 and 790 times the RHDID (recommended human daily inhalation doses) administered during organogenesis in 2 animal models. In rats, tiotropium caused fetal resorption, litter loss, decreases in the number of live pups at birth and the mean pup weights, and a delay in pup sexual maturation at approximately 40 times the RHDID.
In rabbits, tiotropium caused an increase in post-implantation loss at approximately 430 times the RHDID, which was also maternotoxic. Such effects were not observed at approximately 5 and 95 times the RHDID in rats and rabbits respectively.

Olodaterol:
Doses of inhaled olodaterol at 1353 and 2731 times the RHDID were not teratogenic in 2 animal models when given during organogenesis. Placental transfer of olodaterol was observed in pregnant rats. Olodaterol has been shown to be teratogenic in New Zealand rabbits at approximately 7130 times the RHDID. Olodaterol exhibited the following fetal toxicities: enlarged or small heart atria or ventricles, eye abnormalities, and split or distorted sternum. No significant effects occurred at approximately 1353 times the RHDID.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Comment: The use of this drug during labor should be restricted to patients in whom the benefits clearly outweigh the risks due to a potential interference of beta-agonist with uterine contractility.

See references

Benefit should outweigh risk.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

Separate intravenous tiotropium doses of 10 mg/kg and olodaterol doses of 0.4 micromol/kg administered to lactating rats were used to determine drug and metabolite presence in milk at higher than plasma concentrations; because of differences in lactation physiology, the clinical relevance of this is not clear.

See references