Umeclidinium

The Basics

What is Umeclidinium?

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

Brand names for Umeclidinium

Anoro Ellipta

How Umeclidinium is classified

Parasympatholytics, Muscarinic Antagonists, Bronchodilator Agents

Umeclidinium During Pregnancy

Umeclidinium 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 Umeclidinium while pregnant

There are insufficient data on the use of ANORO ELLIPTA or its individual components, umeclidinium and vilanterol, in pregnant women to inform a drug-associated risk. (See Clinical Considerations.) In animal reproduction studies, umeclidinium administered via inhalation or subcutaneously to pregnant rats and rabbits was not associated with adverse effects on embryofetal development at exposures approximately 50 and 200 times, respectively, the human exposure at the maximum recommended human daily inhaled dose (MRHDID). Vilanterol administered via inhalation to pregnant rats and rabbits produced no fetal structural abnormalities at exposures approximately 70 times the MRHDID. (See Data.) The estimated risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Taking Umeclidinium While Breastfeeding

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

Although no published data exist on the use of umeclidinium during breastfeeding, it produces low systemic maternal serum levels and any drug in breastmilk are not likely to be absorbed by the infant. The risk to the breastfed infant of maternal umeclidinium inhalation is small. Combination products such as Anoro Ellipta are likely to be acceptable for similar reasons.

Maternal / infant drug levels

Although no published data exist on the use of umeclidinium during breastfeeding, it produces low systemic maternal serum levels and any drug in breastmilk are not likely to be absorbed by the infant. The risk to the breastfed infant of maternal umeclidinium inhalation is small. Combination products such as Anoro Ellipta are likely to be acceptable for similar reasons.

Possible effects of Umeclidinium on milk supply

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

Possible alternatives to Umeclidinium

Aclidinium, Tiotropium.