Resmetirom

DRUG INFORMATION

  ADULT
    - For patients weighing: o <100 kg, the recommended dosage is 80 mg orally once
      daily. o ≥100 kg, the recommended dosage is 100 mg orally once daily.
      Source: US FDA label for resmetirom (REZDIFFRA), section 'dosage and
      administration', retrieved 2026-08-29
    - For patients weighing: <100 kg, the recommended dosage is 80 mg orally once daily.
      ≥100 kg, the recommended dosage is 100 mg orally once daily.
      Source: US FDA label for resmetirom (REZDIFFRA), section 'dosage and
      administration', retrieved 2026-08-29
    - If REZDIFFRA is used concomitantly with a moderate CYP2C8 inhibitor (e.g.,
      clopidogrel) [see Drug Interactions (7.1) ] , reduce the dosage of REZDIFFRA: <100
      kg, reduce the dosage of REZDIFFRA to 60 mg once daily. ≥100 kg, reduce the dosage
      of REZDIFFRA to 80 mg once daily.
      Source: US FDA label for resmetirom (REZDIFFRA), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - No child dose in this label. That usually means untested in children, not
      unsuitable - use a paediatric source.
      Source: Read and found silent: the US FDA label for resmetirom (REZDIFFRA),
      retrieved 2026-08-29

  RENAL IMPAIRMENT
    - No overall differences in effectiveness but numerically higher incidence of
      adverse reactions have been observed in patients 65 years of age and older
      compared to younger adult patients. 8.6 Renal Impairment The recommended dosage of
      REZDIFFRA in patients with mild, moderate, or severe renal impairment is the same
      as in patients with normal kidney function [see Clinical Pharmacology (12.3) ] .
      Source: US FDA label for resmetirom (REZDIFFRA), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Hepatic Impairment: Avoid use of REZDIFFRA in patients with moderate to severe
      hepatic impairment (Child-Pugh Class B or C).
      Source: US FDA label for resmetirom (REZDIFFRA), section 'use in specific
      populations', retrieved 2026-08-29
    - No overall differences in effectiveness but numerically higher incidence of
      adverse reactions have been observed in patients 65 years of age and older
      compared to younger adult patients. 8.6 Renal Impairment The recommended dosage of
      REZDIFFRA in patients with mild, moderate, or severe renal impairment is the same
      as in patients with normal kidney function [see Clinical Pharmacology (12.3) ] .
      Source: US FDA label for resmetirom (REZDIFFRA), section 'use in specific
      populations', retrieved 2026-08-29
    - Moderate or severe hepatic impairment (Child-Pugh Class B or C) increases
      resmetirom C max and AUC [see Clinical Pharmacology (12.3 ) ], which may increase
      the risk of adverse reactions.
      Source: US FDA label for resmetirom (REZDIFFRA), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY
    - Nothing on pregnancy in this label. Treat as unknown, not as safe.
      Source: Read and found silent: the US FDA label for resmetirom (REZDIFFRA),
      retrieved 2026-08-29

  BREASTFEEDING
    - A pre- and postnatal development study in rats with maternal dosing of resmetirom
      during organogenesis through lactation showed a decrease in birthweight and
      increased incidence of stillbirths and mortality (postnatal days 1-4) at 37 times
      the maximum recommended dose (see Data ) .
      Source: US FDA label for resmetirom (REZDIFFRA), section 'use in specific
      populations', retrieved 2026-08-29
    - A pre- and postnatal development study was performed using oral administration of
      3, 30, or 100 mg/kg/day in female rats during organogenesis through lactation.
      Source: US FDA label for resmetirom (REZDIFFRA), section 'use in specific
      populations', retrieved 2026-08-29
    - No effects were observed in pregnant rats treated orally with up to 100 mg/kg/day
      MGL-3623 (4.7 times the maximum recommended dose based on AUC for MGL-3623) during
      the period of organogenesis. 8.2 Lactation Risk Summary There is no information
      regarding the presence of REZDIFFRA in human or animal milk, the effects on the
      breast-fed infant, or the effects on milk production.
      Source: US FDA label for resmetirom (REZDIFFRA), section 'use in specific
      populations', retrieved 2026-08-29