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Fluticasone / vilanterol Pregnancy and Breastfeeding Warnings

Fluticasone / vilanterol is also known as: Breo Ellipta

Fluticasone / vilanterol Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU pregnancy category: B3 US FDA pregnancy category: C Comments: Patients should contact their physician if pregnancy occurs while taking this drug.

No teratogenicity interactions between fluticasone and vilanterol were seen in animals at the maximum recommended human daily inhalation dose (MRHDID) alone or in combination. Vilanterol caused decreased or absent ossification in cervical vertebral centrum and metacarpals in animals at approximately 1,000 times the MRHDID. Hypoadrenalism occurred in infants born to mothers using corticosteroids during pregnancy. There are no controlled data in human pregnancy. 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. 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.

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Fluticasone / vilanterol Breastfeeding Warnings

US: Caution is recommended. UK: 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 (fluticasone and vilanterol) Excreted into animal milk: Unknown (fluticasone and vilanterol) The effects in the nursing infant are unknown.

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References for pregnancy information

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

References for breastfeeding information

  1. "Product Information. Breo Ellipta (fluticasone-vilanterol)." 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

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