{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "vedolizumab",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "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",
        "cached_file": "labels/vedolizumab.json",
        "verbatim": true
      },
      {
        "text": "Subcutaneous Injection : 108 mg subcutaneously once every two weeks.",
        "source": "US FDA label for vedolizumab (ENTYVIO), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/vedolizumab.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/vedolizumab.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "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",
        "cached_file": "labels/vedolizumab.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "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",
        "cached_file": "labels/vedolizumab.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "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",
        "cached_file": "labels/vedolizumab.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "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",
        "cached_file": "labels/vedolizumab.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/vedolizumab.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/vedolizumab.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "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",
        "cached_file": "labels/vedolizumab.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/vedolizumab.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/vedolizumab.json",
        "verbatim": true
      }
    ]
  }
}