No reports describing the use of aclidinium during human lactation have been located. The molecular weight of the parent drug (about 565) and the long effective half-life (5-8 hours) suggest that the drug will be excreted into breast milk. However, the low (unspecified) plasma concentrations indicate the amount excreted into milk will also be low. The most common adverse reactions in nonpregnant adults were headache, nasopharyngitis, and cough (1).

If a woman is receiving this drug while breastfeeding, her nursing infant should be monitored for these effects.

Aclidinium bromide, a dry powder for inhalation, is indicated for the long-term, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. It is an antimuscarinic agent that is often referred to as an anticholinergic. Aclidinium is rapidly and extensively hydrolyzed to inactive metabolites so that plasma concentrations (not specified) are low. The estimated effective half-life is 5-8 hours (1).

Animal Data: Reproduction studies have been conducted in rats and rabbits. No evidence of structural anomalies was observed in rats exposed during organogenesis to about 15 times the recommended human daily dose based on summed AUC of aclidinium and its metabolites (RHDD) (based on inhaled doses ≤5 mg/kg/day). However, during lactation, exposures that were about 5 times the RHDD (based on inhaled doses ≥0.2 mg/kg/day) resulted in decreased pup weights. These doses also caused maternal toxicity. In rabbits during organogenesis, no evidence of structural anomalies was observed at exposures that were about 20 times the RHDD (based on inhaled doses ≤3.6 mg/kg/day). Compared with controls, an increased incidence of liver lobes was noted at exposures that were about 1400 times the RHDD (based on oral doses ≥150 mg/kg/day) and decreased fetal body weights occurred at exposures that were about 2300 times the RHDD (based on oral doses ≥300 mg/kg/day). Both exposures caused maternal toxicity (1).

Long-term studies for carcinogenicity in mice and rats were negative. In various tests for mutagenicity, both positive and negative assays were noted. In male and female rats given inhaled doses that were about 15 times the RHDD, impaired fertility and reproductive performance were observed, as well as paternal toxicity. However, in other rat studies (treated males mated with untreated females; treated females mated with untreated males), no effects on fertility were observed at inhaled doses, resulting in exposures that were about 30 and 15 times the RHDD, respectively (1).

Placental Transfer: It is not known if aclidinium or its metabolites cross the human placenta. The molecular weight of the parent drug (about 565) and the long half-life suggest that the drug will cross to the embryo-fetus. However, the low (unspecified) plasma concentrations indicate that the amount crossing will also be low.