(taliglucerase alfa)

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Prescribing Information

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17 PATIENT COUNSELING INFORMATION

17 PATIENT COUNSELING INFORMATION

Hypersensitivity Reactions Including Anaphylaxis

Advise patients and caregivers that life-threatening hypersensitivity reactions, including anaphylaxis may occur with ELELYSO treatment.

Advise patients and caregivers that anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy.

Inform patients and caregivers of the symptoms of life‑threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur [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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To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this medication, click the link below to submit your information: 
Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer medication, please call (800) 438-1985.

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or by calling (800) 332-1088.