PRAC recommends a number of measures to reduce the risk of hypersensitivity reactions with ferumoxytol (Rienso®)

The PRAC has concluded that the benefits of ferumoxytol for treating iron deficiency anaemia in CKD continue to outweigh its risks. Measures to reduce the risk of hypersensitivity have however been recommended, including its administration by infusion rather than injection.

The current UK Summary of Product Characteristics for ferumoxytol (Rienso®) states that each 510mg dose should be administered as an undiluted intravenous injection, delivered at a rate of up to 1mL/sec (30mg/sec). The PRAC is advising that it instead be given by intravenous infusion over at least 15 minutes.  The Committee is also advising that it be contra-indicated in patients with any known history of drug allergy.

 

In the June 2014 issue of its Drug Safety Update, the MHRA reminds healthcare professionals of current measures to take to manage and minimise the risk of hypersensitivity reactions with any intravenous iron product. At that time the EU review was ongoing. Further MHRA guidance, considering the conclusions of the EU review, may be issued in due course.