Usual Adult Dose for Thalassemia

Initial dose: 25 mg/kg, orally, 3 times a day (total daily dose: 75 mg/kg)
Maximum dose: 33 mg/kg, orally, 3 times a day (total daily dose: 99 mg/kg)

Comments:

• Round dose to the nearest 250 mg (half tablet).
• Tailor dose to patient response and therapeutic goals (maintenance or reduction of iron burden).
• Approval based on reduction in serum ferritin; there are no trials showing a direct treatment benefit (e.g. improved symptoms, functioning, or survival).
• Safety and efficacy have not been established for transfusional iron overload with other chronic anemias.

Use: Treatment of transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.

Usual Adult Dose for Iron Overload

Initial dose: 25 mg/kg, orally, 3 times a day (total daily dose: 75 mg/kg)
Maximum dose: 33 mg/kg, orally, 3 times a day (total daily dose: 99 mg/kg)

Comments:

• Round dose to the nearest 250 mg (half tablet).
• Tailor dose to patient response and therapeutic goals (maintenance or reduction of iron burden).
• Approval based on reduction in serum ferritin; there are no trials showing a direct treatment benefit (e.g. improved symptoms, functioning, or survival).
• Safety and efficacy have not been established for transfusional iron overload with other chronic anemias.

Use: Treatment of transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.

Usual Pediatric Dose for Thalassemia

8 years and older:
Initial dose: 25 mg/kg, orally, 3 times a day (total daily dose: 75 mg/kg)
Maximum dose: 33 mg/kg, orally, 3 times a day (total daily dose: 99 mg/kg)

Comments:

• Round dose to the nearest 250 mg (half tablet).
• Tailor dose to patient response and therapeutic goals (maintenance or reduction of iron burden).
• Approval based on reduction in serum ferritin; there are no trials showing a direct treatment benefit (e.g. improved symptoms, functioning, or survival).
• Safety and efficacy have not been established for transfusional iron overload with other chronic anemias.

Use: Treatment of transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.

Usual Pediatric Dose for Iron Overload

8 years and older:
Initial dose: 25 mg/kg, orally, 3 times a day (total daily dose: 75 mg/kg)
Maximum dose: 33 mg/kg, orally, 3 times a day (total daily dose: 99 mg/kg)

Comments:

• Round dose to the nearest 250 mg (half tablet).
• Tailor dose to patient response and therapeutic goals (maintenance or reduction of iron burden).
• Approval based on reduction in serum ferritin; there are no trials showing a direct treatment benefit (e.g. improved symptoms, functioning, or survival).
• Safety and efficacy have not been established for transfusional iron overload with other chronic anemias.

Use: Treatment of transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

No adjustment recommended for mild or moderate hepatic impairment.

Dose Adjustments

• If serum ferritin consistently falls below 500 mcg/L, consider temporarily interrupting therapy.

Precautions

US BOXED WARNING: NEUTROPENIA/AGRANULOCYTOSIS

• May cause agranulocytosis that can lead to serious infections and death.
• Neutropenia may precede agranulocytosis.

Recommendations:

• Measure absolute neutrophil count (ANC) prior to therapy, and every week during therapy.
• If infection develops, monitor ANC more frequently.
• Advise patients to immediately report infection symptoms such as fever, sore throat, and flu-like symptoms.

Safety and efficacy have not been established in patients younger than 8 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available.

Other Comments

Administration advice:

• Advise patients to take this medication in the morning, midday, and evening.
• Taking this medication with meals may reduce nausea.
• If a dose is missed, take as soon as possible. If it is almost time for the next dose, skip the missed dose; do not catch-up or double doses.

Monitoring:

• Monitor serum ferritin concentration every 2 to 3 months.

Patient advice:

• Advise patients to immediately report infection symptoms such as fever, sore throat, and flu-like symptoms.