Deferiprone

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. FERRIPROX Tablets are an iron chelator 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.

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.

FERRIPROX Tablets are available in two different 1,000 mg formulations, which have different dosing regimens to achieve the same total daily dosage. 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. FERRIPROX Tablets (twice a day), 1,000 mg: • Starting oral dosage: 75 mg/kg/day (actual body weight) in two divided doses. • Maximum oral dosage: 99 mg/kg/day (actual body weight) in two divided doses. FERRIPROX Tablets (three times a day), 1,000 mg: ○ Starting oral dosage: 75 mg/kg/day (actual body weight) in three divided doses ○ Maximum oral dosage: 99 mg/kg/day (actual body weight) in three divided doses

FERRIPROX is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulations. 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.

Boxed warning (agranulocytosis and neutropenia • ferriprox): can cause agranulocytosis that can lead to serious infections and death. Neutropenia may precede the development of agranulocytosis. • Measure the absolute neutrophil count (ANC) before starting FERRIPROX therapy and monitor regularly while on therapy. • Interrupt FERRIPROX therapy if neutropenia develops. • Interrupt FERRIPROX if infection develops, and monitor the ANC more frequently. 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.

The following clinically significant adverse reactions are described below and elsewhere in the labeling: Agranulocytosis and Neutropenia Liver Enzyme Elevations Zinc Deficiency The most common adverse reactions in patients with thalassemia (incidence ≥ 6%) are nausea, vomiting, abdominal pain, arthralgia, ALT increased and neutropenia. The most common adverse reactions in patients with sickle cell disease or other anemias (incidence ≥6%) are pyrexia, abdominal pain, bone pain, headache, vomiting, pain in extremity, sickle cell anemia with crisis, back pain, ALT increased, AST increased, arthralgia, oropharyngeal pain, nasopharyngitis, neutrophil count decreased, cough and nausea.

Drugs Associated with Neutropenia or Agranulocytosis: Avoid co-administration. If co-administration is unavoidable, closely monitor the absolute neutrophil count. UGT1A6 Inhibitors: Avoid co-administration. Polyvalent Cations: Allow at least a 4-hour interval between administration of FERRIPROX and drugs or supplements containing polyvalent cations (e.g., iron, aluminum, or zinc).

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). They are provided in HDPE bottles. 1,000 mg film-coated tablets, 50 tablets NDC 10122-103-05 Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Keep the bottle tightly closed to protect from moisture.