Ferriprox Dosage

2.1 Important Dosage and Administration Information

FERRIPROX Tablets 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
• FERRIPROX Tablets (three times a day) - 1,000 mg - given three times a day
• FERRIPROX Tablets - 500 mg - given three times a day

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.

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.

Due to the risk of hepatic transaminase elevations, monitor ALT before and monthly during FERRIPROX therapy.

Due to the risk of zinc deficiency, monitor zinc levels before and regularly during FERRIPROX therapy.

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

Starting Dosage for Twice 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.

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 for Twice 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.

2.3 Recommended Dosage for 1,000 mg FERRIPROX Tablets (three times a day) for Adult and Pediatric Patients with Transfusional Iron Overload due to Thalassemia Syndromes, Sickle Cell Disease or Other Anemias

Starting Dosage for Three Times a Day Tablets

The recommended starting oral dosage of FERRIPROX Tablets (three times a day) is 75 mg/kg/day (actual body weight), in three divided doses per day. Table 3 describes the number of FERRIPROX Tablets (three times a day) needed to achieve the 75 mg/kg/day total starting dosage). Round dose to the nearest 500 mg (half-tablet).

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 for Three Times Daily Tablets

Tailor dosage adjustments for FERRIPROX Tablets (three times a day) to the individual patient’s response and therapeutic goals (maintenance or reduction of body iron burden). The maximum oral dosage is 99 mg/kg/day (actual body weight), in three divided doses per day. Table 4 describes the number of FERRIPROX Tablets (three times a day) needed to achieve the 99 mg/day total maximum daily dosage.

2.4 Recommended Dosage for 500 mg FERRIPROX Tablets (three times a day) for Adult and Pediatric Patients with Transfusional Iron Overload due to Thalassemia Syndromes, Sickle Cell Disease or Other Anemias

Starting Dosage for Three Times a Day Tablets

The recommended starting oral dosage of FERRIPROX Tablets (three times a day) is 75 mg/kg/day (actual body weight), in three divided doses per day. Table 5 describes the number of FERRIPROX Tablets (three times a day) needed to achieve the 75 mg/kg/day total starting dosage. Round dose to the nearest 250 mg (half-tablet).

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 for FERRIPROX Tablets (three times a day) to the individual patient’s response and therapeutic goals (maintenance or reduction of body iron burden). The maximum oral dosage is 99 mg/kg/day (actual body weight), in three divided doses per day. Table 6 describes the number of FERRIPROX Tablets (three times a day) needed to achieve the 99 mg/day total maximum daily dosage.

2.5 Monitoring Ferritin Levels to Assess Efficacy

Monitor serum ferritin concentration every two to three months to assess the effect of FERRIPROX on body iron stores. If the serum ferritin is consistently below 500 mcg/L, consider temporarily interrupting FERRIPROX therapy until serum ferritin rises above 500 mcg/L.

2.6 Dosage Modification for Drug Interactions

Allow at least a 4-hour interval between administration of FERRIPROX and other drugs or supplements containing polyvalent cations such as iron, aluminum, or zinc.