This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Comments:
-There is no data on use in pregnant women.
-Animal studies in mice, rats, and rabbits at 1/3 to 8 times the maximum recommended human dose (MRHD) caused increased fetal malformations and decreased fetal survival and growth, however experience with oral corticosteroids suggests rodents are more prone to corticosteroid teratogenicity than humans.
-Infants born of mothers who received corticosteroids during pregnancy should be observed for hypoadrenalism.
-Most women will require a lower exogenous corticosteroid dose and many will not need corticosteroid treatment during pregnancy.

Animal embryofetal development studies of subcutaneous dosing throughout organogenesis produced cleft palate at doses less than the maximum recommended daily nasal dose (MRHDID) and decreased fetal survival at approximately 2 times the MRHDID. Another embryofetal development study or topical administration showed fetal umbilical hernia at approximated 10 times the MRHDID and delays in fetal ossification at approximately 6 times the MRHDID. A reproductive study of subcutaneous administration throughout pregnancy or in late gestation showed prolonged and difficult labor, fewer live births, lower birth weights, and reduced early pup survival at a dose less than the MRHDID (15 mg/kg), and not findings at 7.5 mcg/kg. An embryofetal study of other topical dermal or oral administration throughout organogenesis showed multiple fetal malformations (e.g. flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at approximately 6 times the MRHDID; the oral rout increased fetal reapportions and cleft palates and/or head malformations (hydrocephaly, domed head) at approximately 30 times the MRHDID; most litters were aborted or resorbed at 110 times the MRHDID, and no effects were seen at approximately 6 times MRHDID. 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%.


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

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

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.
-Other corticosteroids are excreted 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.
-The safety and effectiveness of the implant in nursing females have not been established.

See references