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ELELYSO®Medication Guide (taliglucerase alfa)

17 PATIENT COUNSELING INFORMATION

Hypersensitivity Reactions Including Anaphylaxis

Advise patients and caregivers that reactions related to administration and infusion may occur during and after ELELYSO treatment, including severe hypersensitivity reactions such as anaphylaxis. Inform patients of the signs and symptoms of hypersensitivity reactions, and have them seek medical care should signs and symptoms occur. Inform patients that they should be carefully re-evaluated for treatment with ELELYSO if serious hypersensitivity reactions, including anaphylaxis, occur. Reduction of the infusion rate and/or pre-treatment with antihistamines, antipyretics and/or corticosteroids may prevent subsequent reactions [see Warnings and Precautions (5.1)].

This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

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