{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "finerenone",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "The recommended starting dosage is 10 mg or 20 mg orally once daily based on eGFR and serum potassium thresholds.",
        "source": "US FDA label for finerenone (Kerendia), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/finerenone.json",
        "verbatim": true
      },
      {
        "text": "( 2.1 ) Increase dosage after 4 weeks to the target dose of 20 mg once daily for CKD and T2DM based on eGFR and serum potassium thresholds.",
        "source": "US FDA label for finerenone (Kerendia), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/finerenone.json",
        "verbatim": true
      },
      {
        "text": "( 2.3 ) Increase dosage after 4 weeks to the target dose of 20 mg or 40 mg once daily for HF with LVEF ≥ 40% based on eGFR and serum potassium thresholds.",
        "source": "US FDA label for finerenone (Kerendia), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/finerenone.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and efficacy of Kerendia have not been established in patients below 18 years of age.",
        "source": "US FDA label for finerenone (Kerendia), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/finerenone.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "The recommended starting dosage is 10 mg or 20 mg orally once daily based on eGFR and serum potassium thresholds.",
        "source": "US FDA label for finerenone (Kerendia), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/finerenone.json",
        "verbatim": true
      },
      {
        "text": "( 2.1 ) Increase dosage after 4 weeks to the target dose of 20 mg once daily for CKD and T2DM based on eGFR and serum potassium thresholds.",
        "source": "US FDA label for finerenone (Kerendia), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/finerenone.json",
        "verbatim": true
      },
      {
        "text": "( 2.3 ) Increase dosage after 4 weeks to the target dose of 20 mg or 40 mg once daily for HF with LVEF ≥ 40% based on eGFR and serum potassium thresholds.",
        "source": "US FDA label for finerenone (Kerendia), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/finerenone.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "No dose adjustment is required. 8.6 Hepatic Impairment Avoid use of Kerendia in patients with severe hepatic impairment (Child Pugh C).",
        "source": "US FDA label for finerenone (Kerendia), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/finerenone.json",
        "verbatim": true
      },
      {
        "text": "No dosage adjustment is recommended in patients with mild or moderate hepatic impairment (Child Pugh A or B).",
        "source": "US FDA label for finerenone (Kerendia), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/finerenone.json",
        "verbatim": true
      },
      {
        "text": "Consider additional serum potassium monitoring in patients with moderate hepatic impairment (Child Pugh B) [see Dosing and Administration (2.3) and Clinical Pharmacology (12.3) ].",
        "source": "US FDA label for finerenone (Kerendia), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/finerenone.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary There are no available data on Kerendia use in pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.",
        "source": "US FDA label for finerenone (Kerendia), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/finerenone.json",
        "verbatim": true
      },
      {
        "text": "Animal studies have shown developmental toxicity at exposures about 2 times those expected in humans (see Data ) .",
        "source": "US FDA label for finerenone (Kerendia), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/finerenone.json",
        "verbatim": true
      },
      {
        "text": "The clinical significance of these findings is unclear.",
        "source": "US FDA label for finerenone (Kerendia), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/finerenone.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Lactation: Breastfeeding not recommended ( 8.2 ) 8.1 Pregnancy Risk Summary There are no available data on Kerendia use in pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.",
        "source": "US FDA label for finerenone (Kerendia), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/finerenone.json",
        "verbatim": true
      },
      {
        "text": "When rats were exposed during pregnancy and lactation in the pre- and postnatal developmental toxicity study, increased pup mortality and other adverse effects (lower pup weight, delayed pinna unfolding) were observed at about 2 or 4 times the AUC unbound expected in humans at the dose of 40 mg and 20 mg, respectively.",
        "source": "US FDA label for finerenone (Kerendia), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/finerenone.json",
        "verbatim": true
      },
      {
        "text": "The dose free of findings provides a safety margin of about 2 times for the AUC unbound expected in humans for the 20 mg dose and is in the therapeutic range for the 40 mg dose. 8.2 Lactation Risk Summary There are no data on the presence of finerenone or its metabolite in human milk, the effects on the breastfed infant or the effects of the drug on milk production.",
        "source": "US FDA label for finerenone (Kerendia), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/finerenone.json",
        "verbatim": true
      }
    ]
  }
}