What is the recommended dose of Desirox (Deferasirox) for patients with iron overload?

Deferasirox Dosing for Iron Overload

For transfusional iron overload, start deferasirox at 20 mg/kg/day orally once daily to maintain stable iron levels, or 30 mg/kg/day to achieve negative iron balance and reduce iron burden. 1, 2

Initial Dosing Strategy

Standard starting doses:

• 20 mg/kg/day: Stabilizes serum ferritin and liver iron concentration in patients with established iron overload 2
• 30 mg/kg/day: Achieves negative iron balance and actively reduces serum ferritin and liver iron concentration 2

The choice between these doses depends on the severity of iron overload and therapeutic goals. 2

Dose Escalation

For patients requiring more aggressive iron removal, doses >30 mg/kg/day are effective and safe:

• Doses above 30 mg/kg/day produced statistically significant median decreases in serum ferritin of 440 μg/L in heavily transfused patients 3
• The adverse event profile at higher doses remains consistent with standard dosing, with no worsening of renal or hepatic function 3
• This is particularly important for heavily transfused patients who may require higher doses to reduce body iron burden 3

Indication Criteria

Initiate chelation therapy when:

• Serum ferritin ≥1000 ng/mL 4
• After ≥20 red blood cell transfusions 5, 4
• In patients with anticipated ongoing transfusion requirements 4

Disease-Specific Considerations

For myelodysplastic syndromes (MDS):

• Iron chelation should be considered in transfusion-dependent patients with low-risk disease (RA, RARS, or isolated 5q deletion) and serum ferritin >1000 ng/mL after approximately 25 units of red cells 5
• These patients have median survival >100 months and are more prone to long-term toxicity from iron overload 5

For secondary iron overload due to dyserythropoiesis:

• Deferasirox is given orally as an alternative to deferoxamine (20-40 mg/kg/day) 5

For dialysis patients:

• Deferasirox has been used to treat iron overload in hemodialysis patients, though this represents an emerging indication 5

Administration Details

Dosing formulation:

• Administer as dispersible tablets 30 minutes before meals 1
• Once-daily dosing provides 24-hour chelation due to long half-life 2

Monitoring Requirements

Essential monitoring parameters:

• Serum ferritin every 3 months (monthly if possible) to assess iron burden 4, 1
• Renal function, hepatic function, and complete blood count monthly 4
• Target serum ferritin <1000 ng/mL to prevent organ dysfunction 1

Treatment Duration and Goals

Long-term management:

• Continue therapy for several years to achieve complete iron removal, particularly for cardiac iron 1
• In a 3-year prospective study, median serum ferritin decreased 23% in the first year, 36.7% by 2 years, and 36.5% by 3 years 5
• Changes in serum ferritin correlate with liver iron concentration reductions 5

Common Pitfalls

Adverse events to anticipate:

• Gastrointestinal disturbances are the most common adverse events 5, 2
• Skin rash occurs in approximately 8% of patients but usually resolves with continued therapy 6
• Increased serum creatinine requires monitoring but does not typically necessitate discontinuation 5
• Avoid deferasirox in patients with marginal renal perfusion or acute heart failure 4

Critical safety consideration:

• In the 3-year MDS study, 79.8% of patients discontinued therapy, mainly due to adverse events (24.8%), abnormal laboratory values (13.2%), or death (16.1%), highlighting the importance of careful patient selection and monitoring 5