TGA approves IV iron therapy for kids

2 minute read

Ferric carboxymaltose is the first intravenous iron therapy approved for Australian children.

IV iron treatment ferric carboxymaltose (Ferinject, CSL Seqirus) has been approved by the TGA for use in children aged 1-13 years.

Previously approved for adolescents aged from 14 years and adults, it is now indicated for treating iron deficiency anaemia in children aged one to 13 years when oral iron preparations are ineffective or unable to be used.  

It’s the first IV iron therapy preparation approved for paediatric use in Australia.  

“Iron deficiency is one of the most prevalent medical issues among Australian children,” said paediatric gastroenterologist Associate Professor Daniel Lemberg of Sydney Children’s Hospital in a statement. 

“The news of another treatment option for children aged one to thirteen years when oral iron preparations are ineffective or cannot be tolerated is welcome news.” 

Professor Lemberg said children may be at risk of developing iron deficiency, especially young adolescents who experience rapid growth and heavy menstrual bleeding. 

“Supporting the health and growth of children impacted by this condition remains a key priority, and having an additional treatment option available for this age group is a positive step forward as we do just that,” he said. 

The diagnosis of iron deficiency anaemia must be based on laboratory tests, and the complex is not to be used in anaemia not due to iron deficiency, where there is evidence of iron overload or disturbances in utilisation of iron. 

Associate Professor Pradeep Jayasuriya, a Perth-based GP with a special interest in iron deficiency, said iron deficiency anaemia could disrupt every facet of a child’s daily life. 

“If left untreated, children living with this condition may experience symptoms including fatigue, dizziness, mental fog and struggle with schoolwork,” he said.  

“By ensuring children and their parents have access to the treatments and care they need, we can mitigate the impact the condition has on daily life for those affected.” 

The preparation should be given in two doses based on body weight, at least seven days apart. The updated product information leaflet is here

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