Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122, Parma, Italy
Ferriprox monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.
Ferriprox in combination with another chelator (see section 4.4) is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload (mainly cardiac overload) justifies rapid or intensive correction (see section 4.2).
Deferiprone therapy should be initiated and maintained by a physician experienced in the treatment of patients with thalassaemia.
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.
Dose table for Ferriprox 500 mg film-coated tablets:
| Body weight (kg) | Total daily dose (mg) | Dose (mg, three times/day) | Number of tablets (three times/day) |
|---|---|---|---|
| 20 | 1500 | 500 | 1.0 |
| 30 | 2250 | 750 | 1.5 |
| 40 | 3000 | 1000 | 2.0 |
| 50 | 3750 | 1250 | 2.5 |
| 60 | 4500 | 1500 | 3.0 |
| 70 | 5250 | 1750 | 3.5 |
| 80 | 6000 | 2000 | 4.0 |
| 90 | 6750 | 2250 | 4.5 |
Dose table for Ferriprox 1000 mg film-coated tablets:
| Body weight (kg) | Total daily dose (mg) | Number of 1000 mg tablets* | ||
|---|---|---|---|---|
| Morning | Midday | Evening | ||
| 20 | 1500 | 0.5 | 0.5 | 0.5 |
| 30 | 2250 | 1.0 | 0.5 | 1.0 |
| 40 | 3000 | 1.0 | 1.0 | 1.0 |
| 50 | 3750 | 1.5 | 1.0 | 1.5 |
| 60 | 4500 | 1.5 | 1.5 | 1.5 |
| 70 | 5250 | 2.0 | 1.5 | 2.0 |
| 80 | 6000 | 2.0 | 2.0 | 2.0 |
| 90 | 6750 | 2.5 | 2.0 | 2.5 |
* number of tablets rounded to nearest half tablet
A total daily dose above 100 mg/kg body weight is not recommended because of the potentially increased risk of adverse reactions (see sections 4.4, 4.8, and 4.9).
The effect of Ferriprox in decreasing the body iron is directly influenced by the dose and the degree of iron overload. After starting Ferriprox 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.
In patients for whom monotherapy is inadequate, Ferriprox 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, Ferriprox at 75-100 mg/kg/day should be added to deferoxamine therapy. The product information of deferoxamine should be consulted.
Concurrent use of iron chelators is not recommended in patients whose serum ferritin falls below 500 µg/l due to the risk of excessive iron removal.
There are limited data available on the use of deferiprone in children between 6 and 10 years of age, and no data on deferiprone use in children under 6 years of age.
Dose adjustment is not required in patients with mild, moderate, or severe renal impairment (see section 5.2). The safety and pharmacokinetics of Ferriprox in patients with end stage renal disease are unknown.
Dose adjustment is not required in patients with mildly or moderately impaired hepatic function (see section 5.2). The safety and pharmacokinetics of Ferriprox in patients with severe hepatic impairment are unknown.
For oral use.
No cases of acute overdose have been reported. However, neurological disorders (such as cerebellar symptoms, diplopia, lateral nystagmus, psychomotor slowdown, hand movements and axial hypotonia) have been observed in children who had been voluntarily prescribed more than 2.5 times the maximum recommended dose of 100 mg/kg/day for several years. The neurological disorders progressively regressed after deferiprone discontinuation.
In case of overdose, close clinical supervision of the patient is required.
Ferriprox 500 mg film-coated tablets: 5 years.
Ferriprox 1000 mg film-coated tablets: 4 years.
After first opening use within 50 days.
Ferriprox 500 mg film-coated tablets: Do not store above 30ºC.
Ferriprox 1000 mg film-coated tablets: Do not store above 30ºC.
Keep the bottle tightly closed in order to protect from moisture.
Ferriprox 500 mg film-coated tablets: High density polyethylene (HDPE) bottle with a child resistant polypropylene cap. Pack size of 100 tablets.
Ferriprox 1000 mg film-coated tablets: High density polyethylene (HDPE) bottle with a child resistant polypropylene cap and a desiccant. Pack size of 50 tablets.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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