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

AU TGA pregnancy category: B3
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%.

Animal studies are not available for the combination product. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 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.


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 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

Umeclidinium:
Animal studies of subcutaneous administration during lactation 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 milk.

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Yes (umeclidinium); Data not available (fluticasone, vilanterol)

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references