; Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect EMGALITY from light until use.
• Do not freeze.
• Do not shake.
•EMGALITY may be stored out of refrigeration in the original carton at temperatures up to 30°C (86°F) for up to
7 days. Once stored out of refrigeration, do not place back in the refrigerator.
•If these conditions are exceeded, EMGALITY must be discarded.
•Discard the EMGALITY single-dose prefilled pen or syringe after use in a puncture-resistant container.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Instructions on Self-Administration: Provide guidance to patients and/or caregivers on proper subcutaneous injectiontechnique, including aseptic technique, and how to use the prefilled pen or prefilled syringe correctly [see Instructions forUse]. Instruct patients and/or caregivers to read and follow the Instructions for Use each time they use EMGALITY.
Hypersensitivity Reactions: Advise patients to seek immediate medical attention if they experience any symptoms ofserious or severe hypersensitivity reactions [see Warnings and Precautions (5.1)].
For more information go to www.emgality.com or call 1-833-EMGALITY (1-833-364-2548).
Literature issued: 9/2018
Eli Lilly and Company, Indianapolis, IN 46285, USA
US License Number 1891
Copyright © YYYY, Eli Lilly and Company. All rights reserved.
GAL-B8.0-NL0000-USPI-YYYYMMDD
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761063s000lbl.pdf
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