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| Drug class description : | Chelating agents. |
| Generic Name : | Deferiprone |
| Drug description : | White, scored, capsule-shaped, film-coated tablets imprinted "APO" bisect "500" on one side, plain on the other. |
| Presentation : | Tablets, deferiprone 500mg. |
| Indications : | Treatment of iron overload in patients with thalassaemia major for whom deferoxamine therapy is contraindicated or who present serious toxicity with deferoxamine therapy. |
| Adult Dosage : | Deferiprone therapy should be initiated and maintained by a physician experienced in the treatment of patients with thalassaemia. Given as 25mg/kg body weight, orally, three times a day (total daily dose, 75mg/kg body weight). Dosage per kilogram body weight should be calculated to the nearest half tablet. Refer to the dosage table in the Summary of Product Characteristics. Doses above 100mg/kg/day are not recommended. |
| Child Dosage : | Under six years, no data on use; six to 10 years, limited data six to 10 years, limited data available. |
| Contra Indications : | Hypersensitivity to the active substance or any of the excipients. History of recurrent episodes of neutropenia. History of agranulocytosis. Pregnancy or breastfeeding. Due to the unknown mechanism of deferiprone-induced neutropenia, patients should not take medicinal products known to be associated with neutropenia or those that can cause agranulocytosis. |
| Special Precautions : | May cause neutropenia, including agranulocytosis; monitor neutrophil count every week. Patients should be advised to report immediately to their physician any signs or symptoms of infection (eg, fever, sore throat and flu-like symptoms). Rechallenge is not recommended after neutropenia and is contraindicated after agranulocytosis. Measure serum ferritin concentrations monthly or at least every two months to assess long-term effectiveness of the chelation regimen in controlling the body iron load; consider interruption of therapy if measurements fall below 500 micrograms/L. Monitor plasma zinc levels; supplementation recommended in deficiency. HIV or other immune compromised patients. Impaired renal or hepatic function. Reddish/brown discolouration of urine may occcur. |
| Interactions : | between deferiprone and other medicinal products have not been reported. However, since this compound binds to metallic cations, the potential exists for interactions between deferiprone and trivalent cation- dependent medicinal products such as aluminium-based antacids. Caution should be used when administering deferiprone and vitamin C concurrently. |
| Adverse Reactions : | Agranulocytosis, neutropenia. Reddish/brown discolouration of urine. Nausea, vomiting, appetite. Also, arthropathies, increased ALT values, low plasma zinc levels. Some patients experienced progression of fibrosis associated with an increase in iron overload or hepatitis C. |
| Manufacturer : | Swedish Orphan |
| Drug Availability : | (POM) |
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