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Risankizumab Pregnancy and Breastfeeding Warnings

Risankizumab is also known as: Skyrizi

Medically reviewed by Drugs.com. Last updated on Jul 15, 2019.

Risankizumab Pregnancy Warnings

Benefit should outweigh risk.

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. Human IgG is known to cross the placental barrier; therefore, this drug may be transmitted from the mother to the developing fetus.

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.

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

Risankizumab Breastfeeding Warnings

Safety has not been established.

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

References for pregnancy information

  1. "Product Information. Skyrizi (risankizumab)." AbbVie US LLC, North Chicago, IL.

References for breastfeeding information

  1. "Product Information. Skyrizi (risankizumab)." AbbVie US LLC, North Chicago, IL.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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