Emgality Pregnancy Warnings
Benefit should outweigh risk
AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned
Risk Summary: There are no data on the developmental risks associated with this drug in human pregnancy; animal data have not shown adverse effects on embryofetal development.
Comments: Published data suggest that women with migraine may be at increased risk of preeclampsia during pregnancy.
No adverse effects on development have been observed in rats and rabbits receiving this drug during organogenesis or rats receiving this drug throughout pregnancy and lactation. Tested doses were up to 38 times (rats) and 64 times (rabbits) the plasma exposure expected at recommended human dose. Human immunoglobulin (IgG) is known to cross the placental barrier. There are no controlled data in human pregnancy.
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.
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Emgality Breastfeeding Warnings
Human IgG is known to be excreted in breast milk during the first days after birth, decreasing to low concentrations soon afterward. Use of this drug may be considered after waiting a few days, but only if clinically needed.
Benefit should outweigh risk
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
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.
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