Ferriprox

The recommended initial dose of Ferriprox is 25 mg/kg, orally, three times per day for a total of 75 mg/kg/day. The maximum dose is 33 mg/kg, three times per day for a total of 99 mg/kg/day.

Dose adjustments up to 33 mg/kg, orally, three times per day should be tailored to the individual patient’s response and therapeutic goals (maintenance or reduction of body iron burden). The maximum recommended total daily dose is 99 mg/kg per day. The dose should be rounded by the prescriber to the nearest 250 mg (half-tablet).

Table 1a: Tablet requirement to achieve a 25 mg/kg (rounded to the nearest half-tablet) dose level for administration three times a day. Body Weight (kg) Dose (mg) Number of tablets 20 500 1 30 750 1.5 40 1000 2 50 1250 2.5 60 1500 3 70 1750 3.5 80 2000 4 90 2250 4.5 Table 1b: Tablet requirement to achieve 33 mg/kg (rounded to the nearest half-tablet) dose level for administration three times a day. Body Weight (kg) Dose (mg) Number of tablets 20 660 1.5 30 990 2 40 1320 2.5 50 1650 3.5 60 1980 4 70 2310 4.5 80 2640 5.5 90 2970 6

Monitor serum ferritin concentration every two to three months to assess the effects of Ferriprox on body iron stores. Dose adjustments should be tailored to the individual patient’s response and therapeutic goals (maintenance or reduction of body iron burden). If the serum ferritin falls consistently below 500 mcg/L, consider temporarily interrupting Ferriprox therapy.

2.1 Interactions with Foods, Vitamins and Antacids

Allow at least a 4-hour interval between Ferriprox and other medications or supplements containing polyvalent cations such as iron, aluminum, and zinc [see Drug Interactions (7.3)].

2.1 Interactions with Foods, Vitamins and Antacids

Allow at least a 4-hour interval between Ferriprox and other medications or supplements containing polyvalent cations such as iron, aluminum, and zinc [see Drug Interactions (7.3)].

2.1       Dosing

Starting Dose

The recommended initial dose of FERRIPROX is 25 mg/kg, orally, three times per day for a total of 75 mg/kg/day.

Table 1a: Volume of oral solution (rounded to the nearest 2.5 mL) required to achieve a 25 mg/kg dose for administration three times a day. Body Weight
(kg) Dose (mg) mL of oral solution 20 500 5 30 750 7.5 40 1,000 10 50 1,250 12.5 60 1,500 15 70 1,750 17.5 80 2,000 20 90 2,250 22.5

Dose Adjustments

Dose adjustments should be tailored to the individual patient’s response and therapeutic goals (maintenance or reduction of body iron burden). The maximum dose is 33 mg/kg, three times per day for a total of 99 mg/kg/day. The dose should be rounded by the prescriber to the nearest 2.5 mL.

Table 1b: Volume of oral solution (rounded to the nearest 2.5 mL) required to achieve a 33 mg/kg dose for administration three times a day. Body Weight
(kg) Dose (mg) mL of oral solution 20 660 7.5 30 990 10 40 1,320 12.5 50 1,650 17.5 60 1,980 20 70 2,310 22.5 80 2,640 27.5 90 2,970 30

Monitor serum ferritin concentration every two to three months to assess the effects 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.

After first opening of the bottle, use within 35 days. Store the bottle in the original carton to protect from light. Store FERRIPROX only in the original container. After 35 days, discard the contents of the bottle. Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].

2.2       Interactions with Foods, Vitamins and Drugs

Allow at least a 4-hour interval between FERRIPROX and other medications or supplements containing polyvalent cations such as iron, aluminum, and zinc. Avoid concomitant use of UGT1A6 inhibitors (e.g. diclofenac, probenecid, or silymarin (milk thistle)) with FERRIPROX [see Drug Interactions (7.2 and 7.3), Clinical Pharmacology (12.3)].