Use in Pregnancy: There are limited amount of data from the use of vedolizumab in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
Entyvio is to be used during pregnancy only if the benefits clearly outweigh any potential risk to both the mother and foetus.
Use in Lactation: It is unknown whether vedolizumab is excreted in human milk or absorbed systemically after ingestion.
Available pharmacodynamic/toxicological data in animals have shown excretion of vedolizumab in milk (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
Because maternal antibodies (IgG) are excreted in breast milk, it is recommended that a decision be made whether to discontinue breast-feeding or to discontinue/abstain from Entyvio therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: There are no data on the effects of vedolizumab on human fertility. Effects on male and female fertility have not been formally evaluated in animal studies (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
Women of childbearing potential: Women of childbearing potential are strongly recommended to use adequate contraception to prevent pregnancy and to continue its use for at least 18 weeks after the last treatment with