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Ustekinumab Pregnancy and Breastfeeding Warnings

Ustekinumab is also known as: Stelara

Ustekinumab Pregnancy Warnings

Developmental toxicity studies in animals found no evidence of harm to the fetus due to this drug. There are no controlled data in human pregnancy. 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 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.

Use is recommended only if clearly needed and the benefit outweighs the risk. AU TGA pregnancy category: B1 US FDA pregnancy category: B Comment: -Women of childbearing potential should use effective methods of contraception during treatment and for at least 15 weeks after treatment.

See references

Ustekinumab Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.

No information is available on the clinical 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.

See references

References for pregnancy information

  1. "Product Information. Stelara (ustekinumab)." Centocor Inc, Malvern, PA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Stelara (ustekinumab)." Centocor Inc, Malvern, PA.
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

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