Risankizumab Pregnancy and Breastfeeding Warnings

Brand names: Skyrizi

Medically reviewed by Drugs.com. Last updated on Feb 20, 2024.

Risankizumab Pregnancy Warnings

Safety has not been established.
-According to some authorities, this drug should be avoided during pregnancy.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned.

Risk Summary: Clinical data is insufficient to establish a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcome.

Comments:
-Monoclonal antibodies can be actively transported across the placental barrier and may cause immunosuppression to the exposed infant.
-There are adverse pregnancy outcomes reported in women with inflammatory bowel disease.
-There is a pregnancy exposure registry that monitors outcomes in women who become pregnant while in treatment with this drug. Patients are encouraged to enroll at http://glowpregnancyregistry.com.

Animal studies conducted in cynomolgus monkeys 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.

See references

Risankizumab Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Until more data is available, this drug should be used with caution during breastfeeding, especially when nursing a newborn or preterm infant.
-Waiting for at least 2 weeks postpartum to resume therapy is recommended.

This drug is a large protein molecule and the amount in milk is likely to be very low; absorption is unlikely because it is probably destroyed in the infant GI tract.

See references

Further information

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

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