Zinbryta Pregnancy Warnings
Animal studies failed to show adverse effects on the developing embryo except at doses 30 times the recommended human dose. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.
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.
This drug should be used during pregnancy only if the benefit outweighs the risk.
AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned
Comments:
-IgG antibodies are known to cross the placenta.
Risk Summary: There are no adequate data on the developmental risk associated with use of this drug in pregnant women.
See references
Zinbryta Breastfeeding Warnings
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:
-Human IgG is excreted into human milk.
-The effects in the nursing infant are unknown.
Because this drug is a large protein molecule with a molecular weight of about 144,000, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract. Some experts recommend avoiding breastfeeding.
See references
