Ongentys Pregnancy Warnings
Not Recommended
AU TGA pregnancy category: B2
US FDA pregnancy category: Not Assigned
Risk Summary: There are no adequate data on the developmental risk associated with use of this drug in pregnant women. Based on animal data, this drug may cause fetal harm.
Comments:
-This drug is not recommended in women of childbearing potential not using contraception.
Oral administration to pregnant rabbits during the period of organogenesis resulted in increased incidence of structural abnormalities at all doses tested with maternal toxicity observed at all but the lowest dose tested. Oral administration to rats throughout gestation did not show adverse effects on embryofetal development. Additionally, this drug is always given concomitantly with levodopa/carbidopa, which is known to cause developmental toxicity in rabbits. There are no controlled data in human pregnancy.
AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no 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.
See references
Ongentys Breastfeeding Warnings
Use is not recommended
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.
Oral administration of this drug to lactating rats resulted in drug levels (or metabolites) similar to that of maternal plasma levels.
See references
