Etanercept

DRUG INFORMATION

  ADULT
    - Recommended Dosage for Adult Patients with RA, AS, PsA and PsO Patient Population
      Recommended Dosage Adult RA, AS, and PsA 50 mg weekly Adult PsO Starting Dose : 50
      mg twice weekly for 3 months Maintenance Dose : 50 mg once weekly See the Enbrel
      (etanercept) "Instructions for Use" insert for detailed information on injection
      site selection and dose administration [see Dosage and Administration (2.3) and
      Patient Counseling Information (17) ] .
      Source: US FDA label for etanercept (ENBREL), section 'dosage and administration',
      retrieved 2026-08-29
    - Based on a study of 50 mg Enbrel twice weekly in patients with RA that suggested
      higher incidence of adverse reactions but similar American College of Rheumatology
      (ACR) response rates, doses higher than 50 mg per week are not recommended.
      Source: US FDA label for etanercept (ENBREL), section 'dosage and administration',
      retrieved 2026-08-29
    - Adult Plaque Psoriasis Patients In addition to the 50 mg twice weekly recommended
      starting dose, starting doses of 25 mg or 50 mg per week were shown to be
      efficacious.
      Source: US FDA label for etanercept (ENBREL), section 'dosage and administration',
      retrieved 2026-08-29

  CHILD
    - Polyarticular Juvenile Idiopathic Arthritis The safety and effectiveness of Enbrel
      have been established in pediatric patients 2 years of age and older with pJIA.
      Enbrel has been studied in 69 children with moderately to severely active
      polyarticular JIA 2 to 17 years of age. The safety and effectiveness of Enbrel in
      pediatric patients less than 2 years of age with pJIA have not been established.
      Source: US FDA label for etanercept (ENBREL), section 'pediatric use', retrieved
      2026-08-29
    - Recommended Dosage for Pediatric Patients with pJIA, PsO and JPsA Body Weight
      Recommended Dosage 63 kg (138 pounds) or more 50 mg weekly Less than 63 kg (138
      pounds) 0.8 mg/kg weekly To achieve pediatric doses other than 25 mg or 50 mg, use
      Enbrel solution in a single-dose vial or reconstituted lyophilized powder in a
      multiple-dose vial.
      Source: US FDA label for etanercept (ENBREL), 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 etanercept (ENBREL), 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 etanercept (ENBREL), retrieved
      2026-08-29

  PREGNANCY
    - Risk Summary Available studies with use of etanercept during pregnancy do not
      reliably support an association between etanercept and major birth defects.
      Source: US FDA label for etanercept (ENBREL), section 'pregnancy', retrieved
      2026-08-29
    - Clinical data are available from the Organization of Teratology Information
      Specialists (OTIS) Enbrel Pregnancy Registry in women with rheumatic diseases or
      psoriasis and a Scandinavian study in pregnant women with chronic inflammatory
      disease.
      Source: US FDA label for etanercept (ENBREL), section 'pregnancy', retrieved
      2026-08-29
    - Both the OTIS Registry and the Scandinavian study showed the proportion of
      liveborn infants with major birth defects was higher for women exposed to
      etanercept compared to diseased etanercept unexposed women.
      Source: US FDA label for etanercept (ENBREL), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - In a peri-and post-natal development study with pregnant rats that received
      etanercept during organogenesis and the later gestational period from GD 6 through
      21, development of pups through post-natal day 4 was unaffected at doses that
      achieved exposures 48 times the exposure in patients treated with 50 mg Enbrel
      once weekly (on an AUC basis with maternal subcutaneous doses up to 30 mg/kg/day).
      Source: US FDA label for etanercept (ENBREL), section 'use in specific
      populations', retrieved 2026-08-29
    - There have been no consistent reports of adverse events in breastfed infants over
      decades of use.
      Source: US FDA label for etanercept (ENBREL), section 'use in specific
      populations', retrieved 2026-08-29
    - The developmental and health benefits of breastfeeding should be considered along
      with the mother's clinical need for Enbrel and any potential adverse effects on
      the breastfed child from the drug or from the underlying maternal condition.
      Source: US FDA label for etanercept (ENBREL), section 'use in specific
      populations', retrieved 2026-08-29