Incruse ellipta Pregnancy Warnings
There was no evidence of teratogenicity in animals at approximately 50 and 200 times the maximum recommended human daily inhaled dose (MRHDID) administered during organogenesis. There are no adequate and well-controlled studies in pregnant women. 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%.
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 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.
The manufacturer makes no recommendation regarding use during pregnancy.
AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned
Comments:
-There is insufficient data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
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Incruse ellipta Breastfeeding Warnings
Subcutaneous administration of 60 mcg/kg/day to lactating rats at resulted in quantifiable umeclidinium levels in 2 of 54 pups, indicating possible transfer of this drug in milk.
The manufacturer makes no recommendation regarding use during lactation.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
-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.
-This drug was found in the plasma of pups of lactating animals, suggesting transfer in milk.
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