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Pregnancy: Vedolizumab should be used during pregnancy only if the benefits to the mother are considered to outweigh the risk to the unborn child.
Lactation: Vedolizumab has been detected in human milk. The effect of Vedolizumab on infants is unknown. In a milk-only lactation study assessing the concentration of vedolizumab in breast milk of lactating women with active ulcerative colitis or Crohn's disease receiving vedolizumab, the concentration of vedolizumab in human breast milk was approximately 0.4% to 2.2% of the maternal serum concentration obtained from historical studies of vedolizumab.
The estimated average daily dose of vedolizumab ingested by the infant was 0.02 mg/kg/day, which is approximately 21% of the body weight-adjusted average maternal daily dose. The use of Vedolizumab in lactating women should take into account the benefit of therapy to the mother and potential risks to the infant.
