Skyrizi pen Pregnancy Warnings
Benefit should outweigh risk.
AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned.
Risk Summary: Limited data available using this drug use in pregnant women are insufficient to evaluate a risk of major birth defects, miscarriage, or adverse maternal or fetal outcome.
Comments:
-IgG is known to cross the placental barrier; therefore, this drug may be transmitted from the mother to the developing fetus.
Animal studies revealed no treatment-related effects on growth and development, malformations, developmental immunotoxicology, or neurobehavioral development in the fetus; however, a dose-dependent increase in fetal/infant loss was noted. No maternal toxicity was found in animal studies. 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 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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Skyrizi pen Breastfeeding Warnings
No information is available on the use of this drug during breastfeeding. Because it is a large protein molecule, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant Gi tract. This drug should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.
Caution is recommended.
Excreted into human milk: Data not available
Excreted into animal milk: Data not available
Comments:
-Maternal IgG is known to be present in human milk.
Comments:
-The effects in the nursing infant are unknown.
See references
