Fluticasone / vilanterol Pregnancy and Breastfeeding Warnings

Brand names: Breo Ellipta

Medically reviewed by Drugs.com. Last updated on Dec 20, 2023.

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.
-Women with poorly or moderately controlled asthma are at increased risk of perinatal outcomes such as pre-eclampsia, prematurity, low birth weight, and small for gestational age neonates.
-Closely monitor pregnant women and adjust medication for optimal asthma control.
-Although there are no studies, because of the potential for beta-agonist interference with uterine contractility, use during labor should be restricted to those in whom benefits clearly outweigh risks.

No teratogenicity interactions between fluticasone and vilanterol were seen in animals at the maximum recommended human daily inhalation dose (MRHDID) alone or in combination when given during organogenesis; the highest doses used were 5 and 40 times the MRHDID.
Animals receiving only fluticasone during organogenesis at doses approximately 4 times the MRHDID did not show any structural abnormalities; studies giving approximately 1 times the MRHDID during late gestation and lactation showed no observed effects on offspring development.
Vilanterol caused decreased or absent ossification in cervical vertebral centrum and metacarpals in animals at approximately 1,000 times and 13,000 times the MRHDID; no evidence of structural abnormalities were seen at doses approximately 160 times the MRHDID. Vilanterol given to dams during late gestation and lactation at doses up to approximately 3900 times the MRHDID showed no evidence of effects in offspring development.
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

Caution is recommended.

Excreted into human milk: Unknown (fluticasone and vilanterol)
Excreted into animal milk: Unknown (fluticasone and vilanterol)

Comments:
-The effects in the nursing infant or on milk production are unknown.
-Low concentrations of other inhaled corticosteroids have been detected in human milk.
-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

Further information

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