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Ustekinumab Pregnancy and Breastfeeding Warnings

Ustekinumab is also known as: Stelara

Ustekinumab Pregnancy Warnings

Animal studies have revealed no evidence of maternal toxicity, embryotoxicity, or teratogenicity. There are no controlled data in human pregnancy. FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

FDA pregnancy category: B Ustekinumab should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

See references

Ustekinumab Breastfeeding Warnings

Caution is recommended if ustekinumab is administered to a nursing woman. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.

Ustekinumab is excreted in the milk of lactating monkeys. IgG is excreted in human milk, so it is expected that ustekinumab will be present in human milk. It is not known if ustekinumab is absorbed systemically after ingestion. However, published data suggest that antibodies in breast milk do not enter the neonatal and infant circulation in substantial amounts.

See references

References for pregnancy information

  1. "Product Information. Stelara (ustekinumab)." Centocor Inc, Malvern, PA.

References for breastfeeding information

  1. "Product Information. Stelara (ustekinumab)." Centocor Inc, Malvern, PA.

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