Aclidinium

The Basics

What is Aclidinium?

Used as maintenance treatment in patients with chronic obstructive pulmonary disease (COPD).

Brand names for Aclidinium

Duaklir Pressair

How Aclidinium is classified

Anti-Asthmatic Agents, Parasympatholytics, Muscarinic Antagonists, Bronchodilator Agents

Aclidinium During Pregnancy

Aclidinium pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Aclidinium while pregnant

There are no adequate and well-controlled studies of DUAKLIR PRESSAIR or its individual components, formoterol fumarate or aclidinium bromide, in pregnant women to inform drugassociated risks. No adverse developmental effects were seen with inhalation administration of aclidinium bromide to pregnant rats and rabbits during organogenesis at 15 or 20 times, respectively, the maximum recommended human daily inhaled dose (MRHDID). However, reduced pup weights were seen when pregnant rats continued inhalation administration through lactation at 5 times the MRHDID of aclidinium bromide. Adverse developmental effects occurred when rabbits were orally dosed with aclidinium bromide at approximately 1,400 times the MRHDID . Formoterol fumarate alone, administered by the oral route, was teratogenic in rats and rabbits at 1,200 and 49,000 times the MRHDID, respectively. Formoterol fumarate was also embryocidal, increased pup loss at birth and during lactation, and decreased pup weight in rats at 85 times the MRHDID. These adverse effects generally occurred at large multiples of the MRHDID when formoterol fumarate was administered by the oral route to achieve high systemic exposures. No teratogenic, embryocidal, or developmental effects were seen in rats that received inhalation doses up to 280 times the MRHDID . The estimated background risk of major birth defects and miscarriage of the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Labor Or Delivery There are no well-controlled human studies that have investigated the effects of DUAKLIR PRESSAIR during labor and delivery. Because of the potential for beta-agonist interference with uterine contractility, use of DUAKLIR PRESSAIR during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. Data Animal Data Aclidinium Bromide In an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 6-17, no evidence of structural alterations was observed at approximately 15 times the maximum recommended human daily inhaled dose (MRHDID) [based on summed AUCs of aclidinium bromide and its metabolites at inhaled doses less than or equal to 5.0 mg/kg/day]. However, in a pre- and post-natal development study, decreased pup weights were observed when pregnant rats were exposed from gestation day 6 and continuing during the lactation period at approximately 5 times the MRHDID [based on summed AUCs of aclidinium bromide and its metabolites at inhaled doses greater than or equal to 0.2 mg/kg/day]. Maternal toxicity was also observed at inhaled doses greater than or equal to 0.2 mg/kg/day. In an embryo-fetal development study in pregnant Himalayan rabbits administered inhaled doses of aclidinium bromide during the period of organogenesis from gestation days 6-19, no evidence of structural alterations was observed at approximately 20 times the MRHDID [based on summed AUCs of aclidinium bromide and its metabolites at inhaled doses less than or equal to 3.6 mg/kg/day]. However, in another embryo-fetal development study in pregnant Himalayan rabbits dosed orally from gestation days 6-19, increased incidences of additional liver lobes (3-5%), as compared to 0% in the control group, were observed at approximately 1,400 times the MRHDID [based on summed AUCs of aclidinium bromide and its metabolites at oral doses greater than or equal to 150 mg/kg/day], and decreased fetal body weights were observed at approximately 2,300 times the MRHDID [based on summed AUCs of aclidinium bromide and its metabolites at oral doses greater than or equal to 300 mg/kg/day]. These fetal findings were observed in the presence of maternal toxicity. Formoterol Fumarate In a fertility and reproduction study, male rats were orally dosed for 9 weeks and females for 2 weeks prior to pairing and throughout the mating period. Females were either dosed up to gestation day 19 or up until weaning of their offspring. Males were dosed up to 25 weeks. Umbilical hernia was observed in rat fetuses at oral doses 1,200 times and greater than the MRHDID (on a mg/m² basis at maternal oral doses of 3 mg/kg/day and higher). Brachygnathia, abnormal shortness of the mandible, was observed in rat fetuses at a dose 6,000 times the MRHDID (on a mg/m² basis at a maternal oral dose of 15 mg/kg/day). Pregnancy was prolonged at a dose 6,000 times the MRHDID (on a mg/m² basis at a maternal oral dose of 15 mg/kg/day). Fetal and pup deaths occurred at doses approximately 1,200 times the MRHDID and higher (on a mg/m² basis at oral doses of 3 mg/kg/day and higher) during gestation. In an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 6-15, no teratogenic, embryocidal or developmental effects were seen at doses up to 280 times the MRHDID (on a mg/m² basis with maternal inhalation doses up to 0.69 mg/kg/day). In an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation days 6-18, subcapsular cysts on the liver were observed in the fetuses at a dose 49,000 times the MRHDID (on a mg/m² basis with a maternal oral dose of 60 mg/kg/day). No teratogenic effects were observed at doses up to 2,800 times the MRHDID (on a mg/m² basis at maternal oral doses up to 3.5 mg/kg/day). In a pre- and post-natal development study, pregnant female rats received formoterol at oral doses of 0, 0.21, 0.84, and 3.4 mg/kg/day from gestation day 6 through the lactation period. Pup survival was decreased from birth to postpartum day 26 at doses 85 times the MRHDID and higher (on a mg/m² basis at maternal oral doses of 0.21 mg/kg/day and higher), although there was no evidence of a doseresponse relationship. There were no treatment-related effects on the physical, functional, and behavioral development of rat pups.

Taking Aclidinium While Breastfeeding

What are recommendations for lactation if you're taking Aclidinium?

Although no published data exist on the use of aclidinium during breastfeeding, it produces low maternal serum levels because of rapid hydrolysis to inactive metabolites. The risk to the breastfed infant of maternal aclidinium inhalation is small.

Maternal / infant drug levels

Although no published data exist on the use of aclidinium during breastfeeding, it produces low maternal serum levels because of rapid hydrolysis to inactive metabolites. The risk to the breastfed infant of maternal aclidinium inhalation is small.

Possible effects of Aclidinium on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Aclidinium

Tiotropium, Umeclidinium.