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Guselkumab Pregnancy and Breastfeeding Warnings

Guselkumab is also known as: Tremfya

Medically reviewed by Drugs.com. Last updated on Jul 15, 2020.

Guselkumab Pregnancy Warnings

In animal studies on the pre- and post-natal development, no adverse developmental effects were observed in offspring after subcutaneous administration of this drug during organogenesis through parturition at doses up to 30 times the maximum recommended human dose (MRHD). Neonatal animal deaths were observed at 6- to 30-times the MRHD. The clinical significance of these findings is unknown. 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.

Benefit should outweigh risk.

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

Risk Summary: There are no data on the use of this drug in pregnant women to inform a drug associated risk of adverse developmental outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, this drug may be transmitted from the mother to the developing fetus.

See references

Guselkumab Breastfeeding Warnings

Benefit should outweigh risk.

Excreted into human milk: Unknown
Excreted into animal milk: No

Comments:
-Maternal IgG is excreted into human milk.
-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. Tremfya (guselkumab)." Janssen Biotech, Inc., Horsham, PA, PA.

References for breastfeeding information

  1. 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 -]):
  2. "Product Information. Tremfya (guselkumab)." Janssen Biotech, Inc., Horsham, PA, PA.

Further information

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