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Ferriprox 100 mg/ml oral solution (2012)

Active ingredients: Deferiprone

Therapeutic indications

Ferriprox is indicated for the treatment of iron overload in patients with thalassaemia major when deferoxamine therapy is contraindicated or inadequate.

Posology and method of administration

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 2.5 ml. See table below for recommended doses for body weights at 10 kg increments.

Dose table

To obtain a dose of about 75 mg/kg/day, use the volume of oral solution suggested in the following table for the body weight of the patient. Sample body weights at 10 kg increments are listed.

Body weight (kg)Total daily dose (mg)Dose (mg, three times/day)ml of oral solution (three times/day)
2015005005.0
3022507507.5
403000100010.0
503750125012.5
604500150015.0
705250175017.5
806000200020.0
906750225022.5

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 measurements fall below 500 μg/l.

Paediatric population

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.

Method of administration

For oral use.

Overdose

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.

Shelf life

3 years.

After first opening use within 35 days.

Special precautions for storage

Do not store above 30ºC. Store in the original package in order to protect from light.

Nature and contents of container

Amber polyethylene terephthalate (PET) bottles with child resistant closure (polypropylene), and a graduated measuring cup (polypropylene).

Each pack contains one bottle of 250 ml or 500 ml oral solution.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.