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Vedolizumab Pregnancy and Breastfeeding Warnings

Vedolizumab is also known as: Entyvio

Medically reviewed on Jun 6, 2018

Vedolizumab Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: B

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.

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.

A pregnancy registry has been established to monitor maternal-fetal outcomes of pregnant women exposed to vedolizumab. Registry information can be obtained by calling 1877-TAKEDA7 (1-877-825-3327).

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

Vedolizumab Breastfeeding Warnings

Exercise caution when administering to a nursing woman.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

See references

References for pregnancy information

  1. "Product Information. Entyvio (vedolizumab)." Takeda Pharmaceuticals America, Lincolnshire, IL.

References for breastfeeding information

  1. "Product Information. Entyvio (vedolizumab)." Takeda Pharmaceuticals America, Lincolnshire, IL.

Further information

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