FERRIPROX

FERRIPROX- deferiprone tablet
FERRIPROX- deferiprone tablet, film coated
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.

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 Tablets are indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with thalassemia syndromes, sickle cell disease or other anemias.

Limitation s 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

FERRIPRO X T ablets are available in two different 1,000 mg formulations and a 500 mg formulation , which have different oral dosing regimens to achieve the same total daily dosage.

  • FERRIPROX Tablets (twice a day) — 1,000 mg — given two times a day [see Dosage and Administration ( 2.2)]
  • FERRIPROX Tablets (three times a day) — 1,000 mg — given three times a day [see Dosage and Administration ( 2.3)]
  • FERRIPROX Tablets — 500 mg — given three times a day [see Dosage and Administration ( 2.4)]

To prevent medication errors, before prescribing and dispensing, ensure that the tablet formulation is appropriate for the dosing regimen. Each tablet has distinct identifying characteristics [see Dosage Forms and Strengths ( 3)].

For patients who have trouble swallowing tablets, consider the use of FERRIPROX Oral Solution (see the prescribing information for FERRIPROX Oral Solution).

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 1,000 mg FERRIPROX T ablets ( twice a day) for Adult and Pediatric Patients with Transfusional Iron Overload due to Thalassemia Syndromes, Sickle Cell Disease or Other Anemias

Starting Dos ag e for T wice a Day Tablets

The recommended starting oral dosage of FERRIPROX Tablets (twice a day) is 75 mg/kg/day (actual body weight) in two divided doses per day (taken approximately 12 hours apart), with food. Round the total daily dose to the nearest 500 mg (half-tablet). Table 1 describes the number of FERRIPROX Tablets (twice a day) needed to achieve the 75 mg/kg/day total starting daily dosage.

Table 1 : Number of FERRIPROX 1,000 mg T ablets (twice a day) Needed to Achieve the Total Starting Daily Dosage of 75 mg/k g (rounded to the nearest half-tablet)
Body Weight (kg) Morning Evening
20 0.5 1
30 1 1.5
40 1.5 1.5
50 2 2
60 2 2.5
70 2.5 3
80 3 3
90 3.5 3.5

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.

Dos ag e Adjustment s for T wice a Day Tablets

Tailor dosage adjustments of FERRIPROX Tablets (twice a day) to the individual patient’s response and therapeutic goals (maintenance or reduction of body iron burden). The maximum total daily oral dosage is 99 mg/kg (actual body weight) divided into two doses taken approximately 12 hours apart with food. Table 2 describes the number of FERRIPROX Tablets (twice a day) needed to achieve the 99 mg/day total maximum daily dosage.

Table 2 : Number of FERRIPROX 1,000 mg Tablets (twice a day) Needed to A chieve a Total Maximum Recommended Daily Dosage of 99 mg/kg (rounded to the nearest half-tablet)
Body Weight (kg) Morning Evening
20 1 1
30 1.5 1.5
40 2 2
50 2.5 2.5
60 3 3
70 3.5 3.5
80 4 4
90 4.5 4.5

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