Label change for Rienso

After a review of benefit-risk balance of Rienso (ferumoxytol) (AMAG +0.7%), the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) concludes that the product's benefits outweigh the risks. It will recommend a labeling change to the Committee for Medicinal Products for Human Use (CHMP) to better manage the risk of hypersensitivity reactions. The new labeling will stipulate that Rienso be administered by infusion over at least 15 minutes instead of by injection and is contraindicated in patients with any known history of drug allergy.

The Committee reviewed the cases of recent serious hypersensitivity reactions in patients treated with Rienso as part of its routine Periodic Safety Update Report. Commercialization partner Takeda Pharmaceutical Company had to submit additional data to the Committee and participate in an Oral Explanation meeting on July 8.


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