Rienso: hypersensitivity warnings strengthened

24 September 2014

Takeda has issued a letter to healthcare professionals about the risk of serious hypersensitivity reactions associated with the use of its injectable colloidal iron-carbohydrate complex, ferumoxytol (Rienso).

Rienso (ferumoxytol) is indicated for the treatment of iron-deficiency anaemia in chronic kidney disease. | SCIENCE PHOTO LIBRARY

In agreement with the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA), the following changes have been made to the prescribing information for Rienso to mitigate the risk of serious hypersensitivity reactions:

Rienso is now contraindicated in patients with any history of drug allergy, including previous hypersensitivity to other parenteral iron products
Rienso should only be administered as an intravenous infusion after dilution in 50–250ml of sterile 0.9% NaCl or sterile 5% glucose and must be given over at least 15 minutes
Patients should be monitored for signs and symptoms of hypersensitivity reactions, including blood pressure and pulse rate, during and for at least 30 minutes after completion of the infusion
Patients should be advised to seek urgent medical attention if they start to feel unwell
Rienso must only be administered by trained staff in an environment where resuscitation facilities are available

View Rienso drug record

Further information: Takeda

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