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Ferriprox

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Ferriprox

INDICATIONS

FERRIPROX® (deferiprone) is indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.

Approval is based on a reduction in serum ferritin levels. There are no controlled trials demonstrating a direct treatment benefit, such as improvement in disease-related symptoms, functioning, or increased survival [see Clinical Studies].

Limitation of Use

  • Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with other chronic anemias.

DOSAGE AND ADMINISTRATION

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.

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].

HOW SUPPLIED

Dosage Forms And Strengths

500 mg film-coated tablets with a functional score.

Storage And Handling

FERRIPROX® (deferiprone) tablets are white to off-white, capsule-shaped tablets, film-coated, and have a functional score imprinted with “APO” score “500” on one side and are plain on the other. They are provided in a 100 count HDPE bottle with a child-resistant cap. 500 mg film-coated tablets, 100 tablets NDC 52609-0006-1 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep Ferriprox out of the reach and sight of children.

Distributed by ApoPharma USA, Inc., Rockville, MD, United States of America, 20850. Manufactured by Apotex Inc., Toronto, Ontario, Canada, M9L 1T9. Revised: 04/2012

Last reviewed on RxList: 5/4/2012
This monograph has been modified to include the generic and brand name in many instances.

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Additional Ferriprox Information

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