Deferiprone Lipomed

Deferiprone therapy should be initiated and maintained by a physician experienced in the treatment of patients with thalassaemia. Posology Deferiprone is usually given as 25 mg/kg body weight, orally, three times a day for a total daily dose of 75 mg/kg body weight.

Dose per kilogram body weight should be calculated to the nearest half tablet. See tables below for recommended doses for body weights at 10 kg increments. To obtain a dose of about 75 mg/kg/day, use the number of tablets suggested in the following tables for the body weight of the patient.

Sample body weights at 10 kg increments are listed. 9). Dose adjustment The effect of Deferiprone Lipomed in decreasing the body iron is directly influenced by the dose and the degree of iron overload. After starting Deferiprone Lipomed therapy, 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.

Dose adjustments should be tailored to the individual patient’s response and therapeutic goals (maintenance or reduction of body iron burden). Interruption of therapy with deferiprone should be considered if serum ferritin falls below 500 μg/l.

Dose adjustments when used with other iron chelators In patients for whom monotherapy is inadequate, Deferiprone Lipomed may be used with deferoxamine at the standard dose (75 mg/kg/day) but should not exceed 100 mg/kg/day. In the case of iron-induced heart failure, Deferiprone Lipomed at 75-100 mg/kg/day should be added to deferoxamine therapy.

The product information of deferoxamine should be consulted. 4). 2). The safety and pharmacokinetics of Deferiprone Lipomed in patients with end stage renal disease are unknown. 2). The safety and pharmacokinetics of Deferiprone Lipomed in patients with severe hepatic impairment are unknown.

Summary of the safety profile The most common adverse reactions reported during therapy with deferiprone in clinical trials were nausea, vomiting, abdominal pain, and chromaturia, which were reported in more than 10% of patients. 5 x 109/l, which occurred in approximately 1% of patients.

Less severe episodes of neutropenia were reported in approximately 5% of patients. 7 Tabulated list of adverse reactions The adverse reactions are listed below by system organ class (SOC) and by frequency, with the following frequency grouping: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. 4). Data from pooled clinical trials in patients with systemic iron overload show that 63% of the episodes of agranulocytosis occurred within the first six months of treatment, 74% within the first year and 26% after one year of therapy.

6 years) and median duration was 10 days in clinical trials. 3% of the reported episodes of agranulocytosis from clinical trials and post-marketing experience. 5 cases per 100 patient-years). This rate should be considered in the context of the underlying elevated incidence of neutropenia in thalassaemia patients, particularly in those with hypersplenism.

Episodes of diarrhoea, mostly mild and transient, have been reported in patients treated with deferiprone. Gastrointestinal effects are more frequent at the beginning of therapy and resolve in most patients within a few weeks without the discontinuation of treatment.

In some patients it may be beneficial to reduce the dose of deferiprone and then scale it back up to the former dose. Arthropathy events, which ranged from mild pain in one or more joints to severe arthritis with effusion and significant disability, have also been reported in patients treated with deferiprone.

8 ‘Description of selected adverse reactions’). The patient’s absolute neutrophil count (ANC) should be monitored every week during the first year of therapy. For patients whose deferiprone has not been interrupted during the first year of therapy due to any decrease in the neutrophil count, the frequency of ANC monitoring may be extended to the patient’s blood transfusion interval (every 2 – 4 weeks) after one year of deferiprone therapy.

4 below). In clinical trials, weekly monitoring of the neutrophil count has been effective in identifying cases of neutropenia and agranulocytosis. Agranulocytosis and neutropenia usually resolve upon discontinuation of deferiprone, but fatal cases of agranulocytosis have been reported.

If the patient develops an infection while on deferiprone, therapy should be immediately interrupted, and an ANC obtained without delay. The neutrophil count should then be monitored more frequently. Patients should be aware to contact their physician if they experience any symptoms indicative of infection (such as fever, sore throat and flu-like symptoms).

Immediately interrupt deferiprone if the patient experiences infection. 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. 5 x 109/l. 5 x 109/l) 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.

1. • History of recurrent episodes of neutropenia. • History of agranulocytosis. 6). 6). 5). 4