EXJADE (deferasirox)

EXJADE (deferasirox)

SELF ADMINISTRATION - ORAL

Indication for Prior Authorization:

• Treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older.
• Treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L.

Limitation of Use:

• The safety and efficacy of Exjade when administered with other iron chelation therapy have not been established.
   

Coverage Criteria:

Chronic iron overload due to blood transfusions:

• Documented diagnosis of a chronic iron overload due to blood transfusions; AND
• Patient is age 2 years or older; AND
• Inadequate response to chelation therapy; AND
• Serum ferritin level is greater than or equal to 1000 mcg/L; AND
• Creatinine clearance (CrCl) is greater than or equal to 40 mL/min.

Chronic iron overload with NTDT syndromes:

• Documented diagnosis of a non-transfusion dependent thalassemia syndrome; AND
• Patient is age 10 years or older; AND
• LIC is greater than or equal to 5 mg Fe per gram of dry weight; AND
• Serum ferritin level is greater than or equal to 300 mcg/L; AND
• Creatinine clearance (CrCl) is greater than or equal to 40 mL/min.

 Dosing:

• Chronic iron overload due to blood transfusions: 20-40 mg/kg orally daily.
• Chronic iron overload with NTDT syndromes: 10-20 mg/kg orally daily.

Coverage Duration:

1 year

Authorization is Not Covered for the Following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

Additional Information:

• Exjade may cause acute kidney injury, including acute renal failure requiring dialysis and renal tubular toxicity including Fanconi syndrome; hepatic toxicity, including failure; or gastrointestinal hemorrhage.
• Exjade therapy requires close patient monitoring, including laboratory tests of renal and hepatic function.
• Exjade is supplied as tablets for oral suspension: 125 mg, 250 mg, 500 mg.

Review History:

• 07/20/2016 – Annual review.
• 01/15/2021 – Annual review; updated format.

References:

• EXJADE (deferasirox) tablets, for oral suspension [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; July 2020.