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Fluticasone / umeclidinium / vilanterol Pregnancy and Breastfeeding Warnings

Fluticasone / umeclidinium / vilanterol is also known as: Trelegy Ellipta

Medically reviewed on Apr 30, 2018

Fluticasone / umeclidinium / vilanterol Pregnancy Warnings

Use is recommended during late gestation and labor only if clearly needed and the benefit outweighs the risk.

US FDA pregnancy category: Not assigned.

Risk Summary:
-There are insufficient data on the use of this drug or its individual components, fluticasone furoate, umeclidinium, and vilanterol, in pregnant women to inform a drug-associated risk.

Comments:
-Beta-agonists interfere with uterine contractility.
-In clinically recognized pregnancies, the risks of major birth defects are 2% to 4%, and of miscarriage 15% to 20%.

Fluticasone Furoate:
No evidence of structural abnormalities in fetuses was observed in pregnant rats and rabbits receiving this drug during the period of organogenesis, at doses up to approximately 9 and 2 times the maximum recommended human daily inhalation doses (MRHDID). No evidence of effects on offspring development in dams receiving this drug during late gestation and lactation was observed.

Umeclidinium:
No evidence of teratogenic effects was observed in rats and rabbits receiving this drug via inhalation or subcutaneously during the period of organogenesis, at doses up to approximately 50 and 200 times the MRHDID. No evidence of effects on offspring development in dams receiving this drug during late gestation and lactation was observed.

Vilanterol:
No evidence of embryofetal structural abnormalities was observed at any dose in rats or in rabbits up to approximately 160 times the MRHDID. However, fetal skeletal variations were observed in rabbits at approximately 1,000 times the MRHDID. The skeletal variations included decreased or absent ossification in cervical vertebral centrum and metacarpals. No evidence of effects in offspring development was observed in dams received vilanterol during late gestation and the lactation periods at high doses.

Fluticasone Furoate and Vilanterol:
No evidence of embryofetal structural abnormalities was observed in pregnant rats receiving this combination during the period of organogenesis at doses up to approximately 9 and 40 times the MRHDID.

Fluticasone furoate, umeclidinium and vilanterol:
This combination has not been studied in pregnant animals. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Fluticasone / umeclidinium / vilanterol Breastfeeding Warnings

Umeclidinium:
Subcutaneous administration of umeclidinium, one of the ingredients of this drug, to lactating rats at approximately 25 times the maximum recommended human daily inhalation doses (MRHDID) resulted in a quantifiable level of umeclidinium in 2 of 54 pups, which may indicate transfer of umeclidinium in rat 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
Excreted into animal milk: Yes (umeclidinium); Data not available (fluticasone, vilanterol)

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Trelegy Ellipta (fluticasone/umeclidinium/vilanterol)." GlaxoSmithKline, Research Triangle Park, NC.

References for breastfeeding information

  1. "Product Information. Trelegy Ellipta (fluticasone/umeclidinium/vilanterol)." 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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