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Umeclidinium Pregnancy and Breastfeeding Warnings

Umeclidinium is also known as: Incruse Ellipta

Medically reviewed on Aug 8, 2017

Umeclidinium Pregnancy Warnings

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. There are no adequate and well-controlled studies in pregnant women.

AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage.

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

AU TGA pregnancy category: B1
US FDA pregnancy category: C

Comments: Patients should contact their physicians if they become pregnant while taking this drug.

See references

Umeclidinium Breastfeeding Warnings

Subcutaneous administration to lactating rats at approximately 25 times 129 the maximum recommended human daily inhaled dose (MRHDID) in adults resulted in a quantifiable level of umeclidinium in 2 pups, which may indicate transfer of this drug in milk. There are not well-controlled human studies on the use of this drug during lactation.

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
Excreted into animal milk: Yes

The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Incruse Ellipta (umeclidinium)." GlaxoSmithKline, Research Triangle Park, NC.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Incruse Ellipta (umeclidinium)." GlaxoSmithKline, Research Triangle Park, NC.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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