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FC tab: The most serious undesirable effect of deferiprone is the occurrence of a very low white blood cell count. This condition, known as severe neutropenia or agranulocytosis, has occurred in about 1 out of 100 patients who have taken deferiprone in clinical studies. Because white blood cells help to fight infection, a low white blood cell count may place the patient at risk to develop a serious infection. If an infection of this nature is not discovered and treated early, it could cause death. The doctor will ask a blood test (to check the white blood cell count) performed regularly, as frequently as every week. It is very important to keep all of these appointments. Report immediately to the doctor any symptoms of infection such as: fever, sore throat or flu-like symptoms.
The doctor may monitor the patient's serum ALT level at regular intervals during therapy with Ferriprox, and interruption of therapy may be considered if a persistent increase in serum ALT levels occurs.
Ferriprox should be prescribed by a Hematologist, Pediatrician or other Medical Physician.
The doctor will also ask the patient to come in for tests to monitor body iron load. In addition, he or she also might ask for the patient to undergo liver biopsies.
Patients with iron overload are at increased risk of cancer. In these circumstances, the impact of deferiprone is not known.
The positive and negative effects of iron chelation can only be demonstrated after many years. Therefore, further studies are ongoing. In addition, cancer-predicting studies are underway.
Driving and using machines: There is no evidence that Ferriprox affects the ability to drive or use machinery.
Oral soln: Neutropenia/Agranulocytosis: Deferiprone has been shown to cause neutropenia, including agranulocytosis. The patient's neutrophil count should be monitored every week.
In clinical trials, weekly monitoring of the neutrophil count has been effective in identifying cases of neutropenia and agranulocytosis. Neutropenia and agranulocytosis resolved once therapy was withdrawn. If the patient develops an infection while on deferiprone, therapy should be interrupted and the neutrophil count monitored more frequently. Patients should be advised to report immediately to their physician any symptoms indicative of infection such as fever, sore throat and flu-like symptoms.
Suggested management of cases of neutropenia is outlined below. It is recommended that such a management protocol be in place prior to initiating any patient on deferiprone treatment.
Treatment with deferiprone should not be initiated if the patient is neutropenic. The risk of agranulocytosis and neutropenia is higher, if the baseline absolute neutrophil count (ANC) is less than 1.5x109/l.
In the event of neutropenia: Instruct the patient to immediately discontinue deferiprone and all other medicinal products with a potential to cause neutropenia. The patient should be advised to limit contact with other individuals in order to reduce the risk of infection. Obtain a complete blood cell (CBC) count, with a white blood cell (WBC) count, corrected for the presence of nucleated red blood cells, a neutrophil count, and a platelet count immediately upon diagnosing the event and then repeat daily. It is recommended that following recovery from neutropenia, weekly CBC, WBC, neutrophil and platelet counts continue to be obtained for three consecutive weeks, to ensure that the patient recovers fully. Should any evidence of infection develop concurrently with the neutropenia, the appropriate cultures and diagnostic procedures should be performed and an appropriate therapeutic regimen instituted.
In the event of severe neutropenia or agranulocytosis: Follow the guidelines above and administer appropriate therapy such as granulocyte colony stimulating factor, beginning the same day that the event is identified; administer daily until the condition resolves. Provide protective isolation and if clinically indicated, admit patient to the hospital.
Limited information is available regarding rechallenge. Therefore, in the event of neutropenia, rechallenge is not recommended. In the event of agranulocytosis, a rechallenge is contraindicated.
Carcinogenicity/mutagenicity/effects on fertility: In view of the genotoxicity results, a carcinogenic potential of deferiprone cannot be excluded (see Pharmacology: Toxicology under Actions). No animal studies to evaluate the potential effects of deferiprone on fertility have been reported.
Serum ferritin concentration/plasma Zn2+ concentration: It is recommended that serum ferritin concentrations, or other indicators of body iron load, be monitored every two to three months to assess the long-term effectiveness of the chelation regimen in controlling the body iron load. Interruption of therapy with deferiprone should be considered if serum ferritin measurements fall below 500 µg/l.
Monitoring of plasma Zn2+ concentration, and supplementation in case of a deficiency, is recommended.
HIV positive or other immune compromised patients: No data are available on the use of deferiprone in HIV positive or in other immune compromised patients. Given that deferiprone can be associated with neutropenia and agranulocytosis, therapy in immune compromised patients should not be initiated unless potential benefits outweigh potential risks.
Renal or hepatic impairment and liver fibrosis: There are no data available on the use of deferiprone in patients with renal or hepatic impairment. Since deferiprone is eliminated mainly via the kidneys, there may be an increased risk of complications in patients with impaired renal function. Similarly, as deferiprone is metabolised in the liver, caution must be exercised in patients with hepatic dysfunction. Renal and hepatic function should be monitored in this patient population during deferiprone therapy. If there is a persistent increase in serum alanine aminotransferase (ALT), interruption of deferiprone therapy should be considered.
In thalassaemia patients there is an association between liver fibrosis and iron overload and/or hepatitis C. Special care must be taken to ensure that iron chelation in patients with hepatitis C is optimal. In these patients careful monitoring of liver histology is recommended.
Discoloration of urine: Patients should be informed that their urine may show a reddish/brown discoloration due to the excretion of the iron‐deferiprone complex.
Chronic overdose and neurological disorders: Neurological disorders have been observed in children treated with 2.5 to 3 times the recommended dose for several years. Prescribers are reminded that the use of doses above 100 mg/kg/day are not recommended (see Dosage & Administration, Adverse Reactions and Overdosage).
Excipients: Ferriprox oral solution contains the colouring agent Sunset Yellow (E110) which may cause allergic reactions.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.
Use in Pregnancy & Lactation: FC tab: Do not take this medication if breast-feeding, pregnant, or trying to become pregnant. This medication could seriously harm the baby. The patient must use effective contraception while taking Ferriprox. Ask the doctor which method is best. If the patient becomes pregnant while taking Ferriprox, stop taking the medicine immediately and tell the doctor.
