Anoro ellipta Pregnancy Warnings
There are no adequate and well-controlled trials of this drug or its individual components.
Umeclidinium: There was no evidence of teratogenic effects in rats and rabbits at approximately 50 and 200 times the maximum recommended human daily inhaled dose (MRHDID) in adults.
Vilanterol: There were no teratogenic effects in rats and rabbits at approximately 13,000 and 70 times the MRHDID in adults. However, fetal skeletal variations were observed in rabbits at approximately 450 times the MRHDID in adults. The skeletal variations included decreased or absent ossification in cervical vertebral centrum and metacarpals.
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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
AU TGA pregnancy category: B3
FDA pregnancy category: C
Comments: Patients should contact their physicians if they become pregnant while taking this drug.
See references
Anoro ellipta Breastfeeding Warnings
Umeclidinium: Administration to lactating rats at approximately 25 times the MRHDID in adults resulted in a quantifiable level of umeclidinium in 2 pups, which may indicate transfer of umeclidinium in milk.
Vilanterol: Beta2-agonists have been detected in human milk.
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Unknown (umeclidinium and vilanterol)
Excreted into animal milk: Yes (umeclidinium), unknown (vilanterol)
Comments:The effects in the nursing infant are unknown.
See references
