{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "golimumab",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "If possible, complete all age-appropriate vaccinations according to current immunization guidelines [see Warnings and Precautions (5.11) ] . 2.2 Recommended Dosage for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis The recommended SIMPONI dosage in adults is 50 mg administered by subcutaneous injection once a month.",
        "source": "US FDA label for golimumab (Simponi), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/golimumab.json",
        "verbatim": true
      },
      {
        "text": "Table 1: Recommended Subcutaneous Dosage for Adults and Pediatric Patients Weighing at least 15 kg with Moderately to Severely Active Ulcerative Colitis Weight for Patients with UC Recommended Dosage of SIMPONI Week 0 Week 2 Week 6 and every 4 weeks thereafter Adults and pediatric patients 40 kg and greater For pediatric patients weighing 15 kg or greater, administer the appropriate dose using the prefilled syringe (50 mg/0.5 mL or 100 mg/mL).",
        "source": "This line points to a numbered table that this card does not show - read that table in the label before you dose. US FDA label for golimumab (Simponi), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/golimumab.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Ulcerative Colitis The safety and effectiveness of SIMPONI for the treatment of moderately to severely active ulcerative colitis have been established in pediatric patients weighing at least 15 kg. Use of SIMPONI for this indication is supported by evidence from adequate and well-controlled studies in adults with additional safety and efficacy data from an open-label, study in 69 pediatric patients (4 to 17 years of age).",
        "source": "US FDA label for golimumab (Simponi), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/golimumab.json",
        "verbatim": true
      },
      {
        "text": "Concurrent use of stable doses of oral corticosteroids (≤10 mg/day or 0.2 mg/kg/day prednisone or equivalent, whichever was less) and/or NSAIDs was permitted.",
        "source": "US FDA label for golimumab (Simponi), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/golimumab.json",
        "verbatim": true
      },
      {
        "text": "Table 1: Recommended Subcutaneous Dosage for Adults and Pediatric Patients Weighing at least 15 kg with Moderately to Severely Active Ulcerative Colitis Weight for Patients with UC Recommended Dosage of SIMPONI Week 0 Week 2 Week 6 and every 4 weeks thereafter Adults and pediatric patients 40 kg and greater For pediatric patients weighing 15 kg or greater, administer the appropriate dose using the prefilled syringe (50 mg/0.5 mL or 100 mg/mL).",
        "source": "This line points to a numbered table that this card does not show - read that table in the label before you dose. US FDA label for golimumab (Simponi), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/golimumab.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 golimumab (Simponi), retrieved 2026-08-29",
        "cached_file": "labels/golimumab.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 golimumab (Simponi), retrieved 2026-08-29",
        "cached_file": "labels/golimumab.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Available data from postmarketing case reports with golimumab use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.",
        "source": "US FDA label for golimumab (Simponi), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/golimumab.json",
        "verbatim": true
      },
      {
        "text": "An observational study of northern European births observed similar unadjusted rates of major birth defects in infants exposed in utero to golimumab compared to no treatment or non-biologic systemic therapy.",
        "source": "US FDA label for golimumab (Simponi), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/golimumab.json",
        "verbatim": true
      },
      {
        "text": "However, this study had important limitations (see Data ) .",
        "source": "US FDA label for golimumab (Simponi), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/golimumab.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "In a pre- and post-natal development study with pregnant monkeys, subcutaneous administration of golimumab, during the later gestational and lactation periods, at doses producing maximal maternal blood concentrations approximately 460 times those found with the MRHD had no adverse developmental effects on infants (see Data ) .",
        "source": "US FDA label for golimumab (Simponi), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/golimumab.json",
        "verbatim": true
      },
      {
        "text": "Golimumab was present in fetal serum at the end of the second trimester and in neonatal serum from the time of birth and for up to 6 months postpartum. 8.2 Lactation Risk Summary There is no information regarding the presence of SIMPONI in human milk, the effects on breastfed infants, or the effects on milk production.",
        "source": "US FDA label for golimumab (Simponi), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/golimumab.json",
        "verbatim": true
      },
      {
        "text": "Maternal IgG is known to be present in human milk.",
        "source": "US FDA label for golimumab (Simponi), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/golimumab.json",
        "verbatim": true
      }
    ]
  }
}