Infliximab

DRUG INFORMATION

  ADULT
    - ( 2.11 ) Infliximab is administered by intravenous infusion for at least 2 hours
      with an in-line filter ( 2.11 ) Crohn's Disease : 5 mg/kg at 0, 2 and 6 weeks,
      then every 8 weeks.
      Source: US FDA label for infliximab (INFLIXIMAB), section 'dosage and
      administration', retrieved 2026-08-29
    - Some adult patients who initially respond to treatment may benefit from increasing
      the dose to 10 mg/kg every 8 weeks if they later lose their response.
      Source: US FDA label for infliximab (INFLIXIMAB), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2.2 ) Ulcerative Colitis : 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
      Source: US FDA label for infliximab (INFLIXIMAB), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of Infliximab have been established in pediatric
      patients 6 to 17 years of age for induction and maintenance treatment of CD and UC
      [see Dosage and Administration (2.2 , 2.4) and Adverse Reactions (6.1) ] .
      However, the safety and effectiveness of Infliximab in pediatric patients <6 years
      of age with CD or UC have not been established.
      Source: US FDA label for infliximab (INFLIXIMAB), section 'pediatric use',
      retrieved 2026-08-29
    - Prior to treatment, ensure appropriate personnel and medication are available to
      treat reactions (e.g., hypersensitivity) that occur during infusion and shortly
      after infusion. ( 2.11 ) Infliximab is administered by intravenous infusion for at
      least 2 hours with an in-line filter ( 2.11 ) Crohn's Disease : 5 mg/kg at 0, 2
      and 6 weeks, then every 8 weeks.
      Source: US FDA label for infliximab (INFLIXIMAB), section 'dosage and
      administration', retrieved 2026-08-29
    - Concurrent use of folic acid, oral corticosteroids (≤0.2 mg/kg/day of prednisone
      or equivalent), NSAIDs, and/or disease modifying antirheumatic drugs (DMARDs) was
      permitted.
      Source: US FDA label for infliximab (INFLIXIMAB), 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 infliximab (INFLIXIMAB),
      retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Therefore, prescribers should exercise caution when considering resumption of TNF
      blocker therapy in this situation and monitor patients closely. 5.4 Hepatotoxicity
      Severe hepatic reactions, including acute liver failure, jaundice, hepatitis and
      cholestasis, have been reported in postmarketing data in patients receiving
      Infliximab.
      Source: US FDA label for infliximab (INFLIXIMAB), section 'warnings and cautions',
      retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Available observational studies in pregnant women exposed to
      Infliximab showed no increased risk of major malformations among live births as
      compared to those exposed to non-biologics.
      Source: US FDA label for infliximab (INFLIXIMAB), section 'pregnancy', retrieved
      2026-08-29
    - However, findings on other birth and maternal outcomes were not consistent across
      studies of different study design and conduct (see Data ) .
      Source: US FDA label for infliximab (INFLIXIMAB), section 'pregnancy', retrieved
      2026-08-29
    - Monoclonal antibodies such as infliximab are transferred across the placenta
      during the third trimester of pregnancy and may affect immune response in the in
      utero exposed infant (see Clinical Considerations ) .
      Source: US FDA label for infliximab (INFLIXIMAB), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - In a peri- and post-natal development study in mice, no maternal toxicity or
      adverse developmental effects in offspring were observed when dams were
      administered IV doses of 10 or 40 mg/kg of the analogous antibody on GDs 6, 12 and
      18 and lactation days 3, 9 and 15. 8.2 Lactation Risk Summary Published literature
      show that infliximab is present at low levels in human milk.
      Source: US FDA label for infliximab (INFLIXIMAB), section 'use in specific
      populations', retrieved 2026-08-29
    - Systemic exposure in a breastfed infant is expected to be low because infliximab
      is largely degraded in the gastrointestinal tract.
      Source: US FDA label for infliximab (INFLIXIMAB), section 'use in specific
      populations', retrieved 2026-08-29
    - A U.S. multi-center study of 168 women treated with infliximab for inflammatory
      bowel disease (breast milk samples obtained, n=29) showed that infants exposed to
      infliximab through breast milk had no increase in rates of infections and
      developed normally.
      Source: US FDA label for infliximab (INFLIXIMAB), section 'use in specific
      populations', retrieved 2026-08-29