Entyvio Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk.
AU TGA pregnancy category: B2
US FDA pregnancy category: B
Comments:
-A pregnancy exposure registry is available.
-The likelihood of an adverse effect is greater during the second and third trimester. Monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester.
Animal studies showed no fetal harm or adverse effects on pre- or post-natal development at dose levels 20 times the recommended human dose. There are no controlled data in human pregnancy.
To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-TAKEDA7 (1-877-825-3327) or MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS)
Website: https://mothertobaby.org/ongoing-study/entyvio/
AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no 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.
See references
Entyvio Breastfeeding Warnings
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments:
-A risk to the nursing infant cannot be excluded.
-Maternal antibodies (IgG) are excreted in breast milk.
Limited information indicates that this drug is excreted in small amounts in breastmilk and does not adversely affect the nursing infant. Because it is a large protein molecule, absorption is unlikely because it is probably destroyed in the infant's GI tract.
See references
