Adalimumab

DRUG INFORMATION

  ADULT
    - Administer by subcutaneous injection ( 2 ) Rheumatoid Arthritis, Psoriatic
      Arthritis, Ankylosing Spondylitis ( 2.1 ): Adults: 40 mg every other week.
      Source: US FDA label for adalimumab (Adalimumab-aacf), section 'dosage and
      administration', retrieved 2026-08-29
    - Some patients with RA not receiving methotrexate may benefit from increasing the
      dosage to 40 mg every week or 80 mg every other week.
      Source: US FDA label for adalimumab (Adalimumab-aacf), section 'dosage and
      administration', retrieved 2026-08-29
    - Juvenile Idiopathic Arthritis ( 2.2 ): Pediatric Weight 2 Years of Age and Older
      Recommended Dosage 10 kg (22 lbs) to less than 15 kg (33 lbs) 10 mg every other
      week 15 kg (33 lbs) to less than 30 kg (66 lbs) 20 mg every other week 30 kg (66
      lbs) and greater 40 mg every other week Crohn's Disease ( 2.3 ): Adults: 160 mg on
      Day 1 (given in one day or split over two consecutive days); 80 mg on Day 15; and
      40 mg every other week starting on Day 29.
      Source: US FDA label for adalimumab (Adalimumab-aacf), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of Adalimumab-aacf have been established for:
      reducing signs and symptoms of moderately to severely active polyarticular JIA in
      pediatric patients 2 years of age and older. the treatment of moderately to
      severely active Crohn's disease in pediatric patients 6 years of age and older.
      Source: US FDA label for adalimumab (Adalimumab-aacf), section 'pediatric use',
      retrieved 2026-08-29
    - Administer by subcutaneous injection ( 2 ) Rheumatoid Arthritis, Psoriatic
      Arthritis, Ankylosing Spondylitis ( 2.1 ): Adults: 40 mg every other week. Some
      patients with RA not receiving methotrexate may benefit from increasing the dosage
      to 40 mg every week or 80 mg every other week.
      Source: US FDA label for adalimumab (Adalimumab-aacf), section 'dosage and
      administration', retrieved 2026-08-29
    - Juvenile Idiopathic Arthritis ( 2.2 ): Pediatric Weight 2 Years of Age and Older
      Recommended Dosage 10 kg (22 lbs) to less than 15 kg (33 lbs) 10 mg every other
      week 15 kg (33 lbs) to less than 30 kg (66 lbs) 20 mg every other week 30 kg (66
      lbs) and greater 40 mg every other week Crohn's Disease ( 2.3 ): Adults: 160 mg on
      Day 1 (given in one day or split over two consecutive days); 80 mg on Day 15; and
      40 mg every other week starting on Day 29.
      Source: US FDA label for adalimumab (Adalimumab-aacf), 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 adalimumab (Adalimumab-aacf),
      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 adalimumab (Adalimumab-aacf),
      retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Available studies with use of adalimumab during pregnancy do not
      reliably establish an association between adalimumab and major birth defects.
      Source: US FDA label for adalimumab (Adalimumab-aacf), section 'pregnancy',
      retrieved 2026-08-29
    - Clinical data are available from the Organization of Teratology Information
      Specialists (OTIS)/MotherToBaby Pregnancy Registry in pregnant women with
      rheumatoid arthritis (RA) or Crohn's disease (CD) treated with adalimumab.
      Source: US FDA label for adalimumab (Adalimumab-aacf), section 'pregnancy',
      retrieved 2026-08-29
    - Registry results showed a rate of 10% for major birth defects with first trimester
      use of adalimumab in pregnant women with RA or CD and a rate of 7.5% for major
      birth defects in the disease-matched comparison cohort.
      Source: US FDA label for adalimumab (Adalimumab-aacf), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Adalimumab did not elicit harm to the fetuses or malformations. 8.2 Lactation Risk
      Summary Limited data from case reports in the published literature describe the
      presence of adalimumab in human milk at infant doses of 0.1% to 1% of the maternal
      serum concentration.
      Source: US FDA label for adalimumab (Adalimumab-aacf), section 'use in specific
      populations', retrieved 2026-08-29
    - Published data suggest that the systemic exposure to a breastfed infant is
      expected to be low because adalimumab is a large molecule and is degraded in the
      gastrointestinal tract.
      Source: US FDA label for adalimumab (Adalimumab-aacf), section 'use in specific
      populations', retrieved 2026-08-29
    - There are no reports of adverse effects of adalimumab products on the breastfed
      infant and no effects on milk production.
      Source: US FDA label for adalimumab (Adalimumab-aacf), section 'use in specific
      populations', retrieved 2026-08-29