Deferasirox

DRUG INFORMATION

  ADULT
    - • Transfusional Iron Overload: Initial dose for patients with estimated glomerular
      filtration rate (eGFR) greater than 60 mL/min/1.73 m 2 is 14 mg per kg (calculated
      to nearest whole tablet) once daily.
      Source: US FDA label for deferasirox (Deferasirox), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2.1 ) • NTDT Syndromes: Initial dose for patients with eGFR greater than 60
      mL/min/1.73 m 2 is 7 mg per kg (calculated to nearest whole tablet) once daily.
      Source: US FDA label for deferasirox (Deferasirox), section 'dosage and
      administration', retrieved 2026-08-29
    - Use a prediction equation appropriate for adult patients (e.g., CKD-EPI, MDRD
      method) and in pediatric patients (e.g., Schwartz equations). o Obtain urinalyses
      and serum electrolytes to evaluate renal tubular function [see Dosage and
      Administration ( 2.4 ), Warnings and Precautions ( 5.1 )] .
      Source: US FDA label for deferasirox (Deferasirox), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Transfusional Iron Overload The safety and effectiveness of deferasirox have been
      established in pediatric patients 2 years of age and older for the treatment of
      transfusional iron overload [see Dosage and Administration ( 2.1 )] . Safety and
      effectiveness have not been established in pediatric patients less than 2 years of
      age for the treatment of transfusional iron overload.
      Source: US FDA label for deferasirox (Deferasirox), section 'pediatric use',
      retrieved 2026-08-29
    - • Transfusional Iron Overload: Initial dose for patients with estimated glomerular
      filtration rate (eGFR) greater than 60 mL/min/1.73 m 2 is 14 mg per kg (calculated
      to nearest whole tablet) once daily. ( 2.1 ) • NTDT Syndromes: Initial dose for
      patients with eGFR greater than 60 mL/min/1.73 m 2 is 7 mg per kg (calculated to
      nearest whole tablet) once daily.
      Source: US FDA label for deferasirox (Deferasirox), section 'dosage and
      administration', retrieved 2026-08-29
    - Higher rates of renal AEs have been identified among pediatric patients receiving
      deferasirox tablets for oral suspension doses greater than 25 mg/kg/day equivalent
      to 17.5 mg/kg/day deferasirox when their serum ferritin values were less than
      1,000 mcg/L [see Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.1
      , 5.6 ), Adverse Reactions ( 6.1 , 6.2 )] .
      Source: US FDA label for deferasirox (Deferasirox), section 'pediatric use',
      retrieved 2026-08-29

  RENAL IMPAIRMENT
    - • Transfusional Iron Overload: Initial dose for patients with estimated glomerular
      filtration rate (eGFR) greater than 60 mL/min/1.73 m 2 is 14 mg per kg (calculated
      to nearest whole tablet) once daily.
      Source: US FDA label for deferasirox (Deferasirox), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2.1 ) • NTDT Syndromes: Initial dose for patients with eGFR greater than 60
      mL/min/1.73 m 2 is 7 mg per kg (calculated to nearest whole tablet) once daily.
      Source: US FDA label for deferasirox (Deferasirox), section 'dosage and
      administration', retrieved 2026-08-29
    - Prior to starting therapy, or increasing dose, evaluate: • Serum ferritin level •
      Baseline renal function: o Obtain serum creatinine in duplicate (due to variations
      in measurements). o Calculate the estimated glomerular filtration rate (eGFR).
      Source: US FDA label for deferasirox (Deferasirox), section 'dosage and
      administration', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Moderate (Child-Pugh B) Hepatic Impairment: Reduce the starting dose by 50%.
      Source: US FDA label for deferasirox (Deferasirox), section 'dosage and
      administration', retrieved 2026-08-29
    - Severe (Child-Pugh C) Hepatic Impairment: Avoid deferasirox tablets [see Warnings
      and Precautions ( 5.2 ), Use in Specific Populations ( 8.7 )] .
      Source: US FDA label for deferasirox (Deferasirox), section 'dosage and
      administration', retrieved 2026-08-29
    - If either develops, consider dose reduction, interruption or discontinuation of
      deferasirox until glomerular or renal tubular function returns to baseline [see
      Dosage and Administration ( 2.4 , 2.5 ), Warnings and Precautions ( 5.1 )] . 8.7
      Hepatic Impairment Avoid use in patients with severe (Child-Pugh C) hepatic
      impairment.
      Source: US FDA label for deferasirox (Deferasirox), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary There are no studies with the use of deferasirox in pregnant women to
      inform drug-associated risks.
      Source: US FDA label for deferasirox (Deferasirox), section 'pregnancy', retrieved
      2026-08-29
    - Administration of deferasirox to rats during pregnancy resulted in decreased
      offspring viability and an increase in renal anomalies in male offspring at doses
      that were about or less than the recommended human dose on a mg/m 2 basis.
      Source: US FDA label for deferasirox (Deferasirox), section 'pregnancy', retrieved
      2026-08-29
    - No fetal effects were noted in pregnant rabbits at doses equivalent to the human
      recommended dose on an mg/m 2 basis.
      Source: US FDA label for deferasirox (Deferasirox), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Contraception Counsel patients to use non-hormonal method(s) of contraception
      since deferasirox can render hormonal contraceptives ineffective [see Drug
      Interactions ( 7.2 )] .
      Source: US FDA label for deferasirox (Deferasirox), section 'nursing mothers',
      retrieved 2026-08-29
    - Lactation: Advise women not to breastfeed.
      Source: US FDA label for deferasirox (Deferasirox), section 'use in specific
      populations', retrieved 2026-08-29
    - In a prenatal and postnatal developmental study, pregnant rats received oral
      deferasirox daily from organogenesis through lactation day 20 at doses of 10, 30,
      and 90 mg/kg/day (0.1, 0.3, and 1.0 times the MRHD on a mg/m 2 basis).
      Source: US FDA label for deferasirox (Deferasirox), section 'use in specific
      populations', retrieved 2026-08-29