Golimumab

DRUG INFORMATION

  ADULT
    - 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
    - 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

  CHILD
    - 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
    - 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
    - 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

  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 golimumab (Simponi), 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 golimumab (Simponi), retrieved
      2026-08-29

  PREGNANCY
    - 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
    - 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
    - However, this study had important limitations (see Data ) .
      Source: US FDA label for golimumab (Simponi), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - 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
    - 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
    - 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