Vedolizumab

DRUG INFORMATION

  ADULT
    - Intravenous Infusion : 300 mg infused over approximately 30 minutes and then every
      eight weeks thereafter.
      Source: US FDA label for vedolizumab (ENTYVIO), section 'dosage and
      administration', retrieved 2026-08-29
    - Subcutaneous Injection : 108 mg subcutaneously once every two weeks.
      Source: US FDA label for vedolizumab (ENTYVIO), section 'dosage and
      administration', retrieved 2026-08-29
    - Provide proper training to patients and/or caregivers on the subcutaneous
      injection technique of ENTYVIO. 2.2 Recommended Dosage in Adults with Ulcerative
      Colitis and Crohn’s Disease Week 0: Administer ENTYVIO 300 mg by intravenous
      infusion over approximately 30 minutes [ see Dosage and Administration (2.3) ].
      Source: US FDA label for vedolizumab (ENTYVIO), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Safety and effectiveness of ENTYVIO in pediatric patients have not been
      established.
      Source: US FDA label for vedolizumab (ENTYVIO), section 'pediatric use', retrieved
      2026-08-29

  RENAL IMPAIRMENT
    - No kidney-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for vedolizumab (ENTYVIO),
      retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for vedolizumab (ENTYVIO),
      retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Available data from the Organization of Teratology Information
      Specialists (OTIS)/MotherToBaby ENTYVIO Pregnancy Registry, published literature
      and pharmacovigilance in pregnant women have not reliably identified an ENTYVIO-
      associated risk of major birth defects, miscarriage or adverse maternal or fetal
      outcomes (see Data ) .
      Source: US FDA label for vedolizumab (ENTYVIO), section 'pregnancy', retrieved
      2026-08-29
    - There are risks to the mother and the fetus associated with inflammatory bowel
      disease in pregnancy (see Clinical Considerations ) .
      Source: US FDA label for vedolizumab (ENTYVIO), section 'pregnancy', retrieved
      2026-08-29
    - No fetal harm was observed in animal reproduction studies with intravenous
      administration of vedolizumab to rabbits and monkeys at dose levels 20 times the
      recommended human dosage (see Data ) .
      Source: US FDA label for vedolizumab (ENTYVIO), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - A pre- and post-natal development study in monkeys showed no evidence of any
      adverse effect on pre- and post-natal development at intravenous doses up to 100
      mg/kg (about 20 times the recommended human dosage). 8.2 Lactation Risk Summary
      Data from a clinical lactation study show the presence of vedolizumab in human
      milk.
      Source: US FDA label for vedolizumab (ENTYVIO), section 'use in specific
      populations', retrieved 2026-08-29
    - Systemic exposure in a breastfed infant is expected to be low because monoclonal
      antibodies are largely degraded in the gastrointestinal tract.
      Source: US FDA label for vedolizumab (ENTYVIO), section 'use in specific
      populations', retrieved 2026-08-29
    - There are no data on the effects of vedolizumab on the breastfed infant, or the
      effects on milk production.
      Source: US FDA label for vedolizumab (ENTYVIO), section 'use in specific
      populations', retrieved 2026-08-29