{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "sarilumab",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "( 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",
        "cached_file": "labels/sarilumab.json",
        "verbatim": true
      },
      {
        "text": "( 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",
        "cached_file": "labels/sarilumab.json",
        "verbatim": true
      },
      {
        "text": "( 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",
        "cached_file": "labels/sarilumab.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "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",
        "cached_file": "labels/sarilumab.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sarilumab.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "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",
        "cached_file": "labels/sarilumab.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sarilumab.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "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",
        "cached_file": "labels/sarilumab.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sarilumab.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "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",
        "cached_file": "labels/sarilumab.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sarilumab.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sarilumab.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "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",
        "cached_file": "labels/sarilumab.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sarilumab.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sarilumab.json",
        "verbatim": true
      }
    ]
  }
}