Deferiprone

What it is and how it works

Mechanism of Action Deferiprone is a chelating agent with an affinity for ferric ions (iron III). Deferiprone binds with ferric ions to form neutral 3:1 (deferiprone:iron) complexes that are stable at physiological pH.

Mechanism class: Iron Chelating Activity

Indications

Deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. 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. Pediatric use information is approved for Chiesi USA, Inc.’s FERRIPROX ® (deferiprone) tablets. However, due to Chiesi USA, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Deferiprone tablets are an iron chelator indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. 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.

Dosage and administration (summary)

• Deferiprone Tablets are available in a 1,000 mg formulation. • 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. ( 2.1 , 3 ) • Deferiprone Tablets (three times a day), 1,000 mg: o Starting oral dosage: 75 mg/kg/day (actual body weight) in three divided doses o Maximum oral dosage: 99 mg/kg/day (actual body weight) in three divided doses Important Dosage and Administration Information • Deferiprone Tablets (three times a day) - 1,000 mg - given three times a day To prevent medication errors, before prescribing and dispensing, ensure that the tablet f…

Contraindications

Deferiprone tablets are contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulation. The following reactions have been reported in association with the administration of deferiprone: Henoch-Schönlein purpura; urticaria; and periorbital edema with skin rash . Hypersensitivity to deferiprone or to any of the excipients in the formulations.

Warnings and precautions

• Liver Enzyme Elevations: Monitor monthly and discontinue for persistent elevations. • Zinc Deficiency: Monitor during therapy and supplement for deficiency. • Embryo-Fetal Toxicity: Can cause fetal harm. Agranulocytosis and Neutropenia Fatal agranulocytosis can occur with deferiprone tablets use. Deferiprone tablets can also cause neutropenia, which may foreshadow agranulocytosis. Measure the absolute neutrophil count (ANC) before starting deferiprone tablets therapy and monitor it regularly while on therapy .

Pregnancy

Pregnancy Risk Summary: In animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during organogenesis at doses 33% and 49%, respectively, of the maximum recommended human dose (MRHD) resulted in structural abnormalities, embryo-fetal mortality and alterations to growth ( see Data ).

Storage and supply

Deferiprone Tablets (three times a day), 1,000 mg: Deferiprone Tablets (three times a day) are white to off-white, modified capsule shaped, biconvex, film coated tablets, debossed with 54 [score] 23 on one side and plain on the other. They are provided in a 50 count, 150 count, and 300 count HDPE bottle with a child-resistant cap.

Source: Deferiprone (Deferiprone) — US FDA prescribing information, 2025-05-01, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.