Ferric carboxymaltose effective in kids: study


15 Nov 2016

Ferric carboxymaltose (FCM) is an effective treatment for children with anaemia, a study from Melbourne reveals, however it is currently not recommended in Australia for patients younger than 14.

Speaking after the ANZSBT Presidential Symposium on Sunday Dr Gemma Crighton, from the Royal Children’s Hospital, Melbourne, told the meeting that iron deficiency is the most common nutritional deficiency in the world.

“About 8% of Australian preschool children – more than 100,000 – are anaemic, and iron deficiency is the most common contributor in all paediatric age groups. Infants and adolescents are at particular risk.”

Indications for intravenous supplementation include persistent iron deficiency despite oral therapy, contraindications to oral iron (including poor compliance and adverse effects), comorbidities that affect iron absorption, ongoing blood loss, and a need for rapid iron repletion, for example before urgent surgery.

She noted that three intravenous preparations were available in Australia: iron polymaltose (at a cost of about $23), iron sucrose ($40) and, more recently, FCM (at the much higher cost of about $300).

“FCM is dextran-free, which reduces the risk of adverse effects. It offers a faster haematological response, and can be administered over 15 minutes compared to prolonged infusion times needed for the other preparations,” Dr Crighton said.

“The higher cost is offset by the significant reduction in nursing and admission times, and lower risk of readmission in response to complications.”

An initial study at the Royal Children’s Hospital, where FCM has been used since 2013, confirmed the benefits in patients aged 14 or more. Mean infusion time was reduced from 369 to just 38 minutes, the admission time for day-case treatment fell from 440 to 155 minutes, and the rate of adverse events fell from 15% to zero.

A subsequent review of children younger than 14 identified 65 infusions of FCM in 60 patients. Their average age was 9.3 years, and the youngest was 6 months old.

“The most common indication was gastrointestinal disease, especially inflammatory bowel disease, accounting for 38% of patients,” Dr Crighton said.

“This was followed by renal disease, in 17%, and dietary iron deficiency anaemia unresponsive to oral iron, in 12%.”

The median dose was 19 mg/kg, very close to the recommended maximum of 20 mg/kg. Some exceeded this limit, mainly because of ‘rounding up’ the dose to the FCM pack sizes of 100 mg or 500 mg, but higher doses did not lead to any adverse effects.

Haematological responses were as expected with this proven therapy, including an increase in mean haemoglobin from 100 g/L at baseline to 121g/L after treatment, with corresponding increases in MCV and ferritin.

Adverse events related to treatment included multiple attempts at IV access in two young patients, one case of IV extravasation (which resolved without treatment) and one young patient with a sore wrist.

“Our study supports the safety and efficacy of FCM as an IV iron therapy for use in children under 14 years,” Dr Crighton concluded. “Important benefits include the rapidity of infusion, shorter hospital stay and less patient inconvenience.”

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