Sarilumab

DRUG INFORMATION

  ADULT
    - ( 2.1 ) Recommended Dosage in RA The recommended dosage is 200 mg subcutaneously,
      once every 2 weeks.
      Source: US FDA label for sarilumab (KEVZARA), section 'dosage and administration',
      retrieved 2026-08-29
    - ( 2.2 ) Recommended Dosage in PMR The recommended dosage is 200 mg subcutaneously,
      once every two weeks in combination with a tapering course of corticosteroids.
      Source: US FDA label for sarilumab (KEVZARA), section 'dosage and administration',
      retrieved 2026-08-29
    - ( 2.3 ) Recommended Dosage in pJIA The recommended dosage is 200 mg given
      subcutaneously once every 2 weeks for pJIA patients who weigh 63 kg or greater
      using the 200 mg/1.14 mL pre-filled syringe.
      Source: US FDA label for sarilumab (KEVZARA), section 'dosage and administration',
      retrieved 2026-08-29

  CHILD
    - KEVZARA is approved for active polyarticular juvenile idiopathic arthritis (pJIA)
      in pediatric patients who weigh 63 kg or greater. Use of KEVZARA in this patient
      population is supported by evidence from adequate and well-controlled studies of
      KEVZARA in adults with RA, pharmacokinetic data from adult patients with RA, and a
      pharmacokinetic, pharmacodynamic, dose-finding, and safety study in pediatric
      patients with pJIA 2 years of age and older.
      Source: US FDA label for sarilumab (KEVZARA), section 'pediatric use', retrieved
      2026-08-29
    - General Considerations for Administration KEVZARA initiation is not recommended in
      patients with ANC less than 2,000/mm 3 , platelets less than 150,000/mm 3 or liver
      transaminases above 1.5 times ULN. See Full Prescribing Information (FPI) for
      complete information. ( 2.1 ) Recommended Dosage in RA The recommended dosage is
      200 mg subcutaneously, once every 2 weeks.
      Source: US FDA label for sarilumab (KEVZARA), section 'dosage and administration',
      retrieved 2026-08-29

  RENAL IMPAIRMENT
    - As there is a higher incidence of infections in the elderly population in general,
      caution should be used when treating the elderly. 8.6 Hepatic Impairment The
      safety and efficacy of KEVZARA have not been studied in patients with hepatic
      impairment, including patients with positive HBV or HCV serology [see Warnings and
      Precautions (5.6) ] . 8.7 Renal Impairment No dose adjustment is required in
      patients with mild to moderate renal impairment.
      Source: US FDA label for sarilumab (KEVZARA), section 'use in specific
      populations', retrieved 2026-08-29
    - KEVZARA has not been studied in patients with severe renal impairment [see
      Clinical Pharmacology (12.3) ] .
      Source: US FDA label for sarilumab (KEVZARA), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - As there is a higher incidence of infections in the elderly population in general,
      caution should be used when treating the elderly. 8.6 Hepatic Impairment The
      safety and efficacy of KEVZARA have not been studied in patients with hepatic
      impairment, including patients with positive HBV or HCV serology [see Warnings and
      Precautions (5.6) ] . 8.7 Renal Impairment No dose adjustment is required in
      patients with mild to moderate renal impairment.
      Source: US FDA label for sarilumab (KEVZARA), section 'use in specific
      populations', retrieved 2026-08-29
    - Do not administer KEVZARA to patients with known hypersensitivity to sarilumab
      [see Contraindications (4) and Adverse Reactions (6.1) ] . 5.6 Active Hepatic
      Disease and Hepatic Impairment Treatment with KEVZARA is not recommended in
      patients with active hepatic disease or hepatic impairment, as treatment with
      KEVZARA was associated with transaminase elevations [see Adverse Reactions (6.1) ,
      Use in Specific Populations (8.6) ] .
      Source: US FDA label for sarilumab (KEVZARA), section 'warnings and cautions',
      retrieved 2026-08-29

  PREGNANCY
    - Risk Summary The limited human data with KEVZARA in pregnant women are not
      sufficient to inform drug-associated risk for major birth defects and miscarriage.
      Source: US FDA label for sarilumab (KEVZARA), section 'pregnancy', retrieved
      2026-08-29
    - Monoclonal antibodies, such as sarilumab, are actively transported 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 sarilumab (KEVZARA), section 'pregnancy', retrieved
      2026-08-29
    - From animal data, and consistent with the mechanism of action, levels of IgG, in
      response to antigen challenge, may be reduced in the fetus/infant of treated
      mothers (see Clinical Considerations and Data ) .
      Source: US FDA label for sarilumab (KEVZARA), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Lactation: Discontinue drug or nursing taking into consideration importance of
      drug to mother.
      Source: US FDA label for sarilumab (KEVZARA), section 'use in specific
      populations', retrieved 2026-08-29
    - Administration of recombinant IL-6 to ll6-/- null mice restored the normal timing
      of delivery. 8.2 Lactation Risk Summary No information is available on the
      presence of sarilumab in human milk, the effects of the drug on the breastfed
      infant, or the effects of the drug on milk production.
      Source: US FDA label for sarilumab (KEVZARA), section 'use in specific
      populations', retrieved 2026-08-29
    - If sarilumab is transferred into human milk, the effects of local exposure in the
      gastrointestinal tract and potential limited systemic exposure in the infant to
      sarilumab are unknown.
      Source: US FDA label for sarilumab (KEVZARA), section 'use in specific
      populations', retrieved 2026-08-29