FERRIPROX

FERRIPROX- deferiprone solution
Chiesi USA, Inc.

WARNING: AGRANULOCYTOSIS AND NEUTROPENIA

  • FERRIPROX can cause agranulocytosis that can lead to serious infections and death. Neutropenia may precede the development of agranulocytosis. [see Warnings and Precautions (5.1)]
  • Measure the absolute neutrophil count (ANC) before starting FERRIPROX therapy and monitor regularly while on therapy. [see Warnings and Precautions (5.1)]
  • Interrupt FERRIPROX therapy if neutropenia develops. [see Warnings and Precautions (5.1)]
  • Interrupt FERRIPROX if infection develops, and monitor the ANC more frequently. [see Warnings and Precautions (5.1)]
  • Advise patients taking FERRIPROX to report immediately any symptoms indicative of infection. [see Warnings and Precautions (5.1)]

1 INDICATIONS AND USAGE

FERRIPROX Oral Solution is indicated for the treatment of transfusional iron overload in adult and pediatric patients 3 years of age and older with thalassemia syndromes, sickle cell disease or other anemias.

Limitations of Use

  • Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia.

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Information

Monitoring for Safety

Due to the risk of agranulocytosis, monitor ANC before and during FERRIPROX therapy.

Test ANC prior to start of FERRIPROX therapy and monitor on the following schedule during treatment:

  • First six months of therapy: Monitor ANC weekly;
  • Next six months of therapy: Monitor ANC once every two weeks;
  • After one year of therapy: Monitor ANC every two to four weeks (or at the patient’s blood transfusion interval in patients that have not experienced an interruption due to any decrease in ANC [see Warnings and Precautions (5.1)].

Due to the risk of hepatic transaminase elevations, monitor ALT before and monthly during FERRIPROX therapy [see Warnings and Precautions (5.2)].

Due to the risk of zinc deficiency, monitor zinc levels before and regularly during FERRIPROX therapy [see Warnings and Precautions (5.3)].

2.2 Recommended Dosage for FERRIPROX Oral Solution for Adult and Pediatric Patients with Transfusional Iron Overload due to Thalassemia Syndromes, Sickle Cell Disease or Other Anemias

Starting Dosage

The recommended starting oral dosage of FERRIPROX Oral Solution is 25 mg/kg (actual body weight), three times per day for a total of 75 mg/kg/day. Round dose to the nearest 2.5 mL.

Table 1: Volume of FERRIPROX Oral Solution in mL Needed to Achieve the Total Starting Daily Dosage of 75 mg/kg (rounded to the nearest 2.5 mL)
Body Weight (kg) Morning Midday Evening
20 5 5 5
30 7.5 7.5 7.5
40 10 10 10
50 12.5 12.5 12.5
60 15 15 15
70 17.5 17.5 17.5
80 20 20 20
90 22.5 22.5 22.5

To minimize gastrointestinal upset when first starting therapy, dosing can start at 45 mg/kg/day and increase weekly by 15 mg/kg/day increments until the full prescribed dose is achieved.

Dosage Adjustments

Tailor dosage adjustments to the individual patient’s response and therapeutic goals (maintenance or reduction of body iron burden). The maximum oral dosage is 33 mg/kg (actual body weight), three times per day for a total of 99 mg/kg/day.

Table 2: Volume of FERRIPROX Oral Solution in mL Needed to Achieve the Maximum Total Daily Dosage of 99 mg/kg (rouded to the nearest 2.5 mL)
Body Weight (kg) Morning Midday Evening
20 7.5 5 7.5
30 10 10 10
40 15 10 15
50 17.5 15 17.5
60 20 20 20
70 25 22.5 22.5
80 27.5 25 27.5
90 30 30 30

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