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DEFERASIROX TAB,SUSP,ORAL

Clinical Criteria Summary

Exclusion Criteria

  • Creatinine clearance <40 mL/min/1.73m2
  • Severe (Child-Pugh C) hepatic impairment
  • Terminal high-risk Myelodysplastic Syndrome (MDS-excess blasts)
  • Unmanageable CYP2C8, CYP1A2, UGT, bile sequestrant, or aluminum-containing antacid drug interactions
  • Baseline ophthalmology exam not completed
  • Known hypersensitivity to deferasirox or any of its components
  • Breastfeeding

Inclusion Criteria

  • Chronic iron overload due to red blood cell transfusion dependence
  • Chronic iron overload in patients with non-transfusion-dependent thalassemia (NTDT) syndromes, and a liver iron concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L

Additional Inclusion Criteria

  • Care is provided by a VA/VA Community Care oncology or hematology provider
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Pregnancy Counseling Requirement

  • For patients who can become pregnant and patients with partners who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective non-hormonal contraception during therapy

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