Safety


Safety evaluated across three Phase 3 trials1,2

The safety of Emgality was assessed in a large clinical trial program in migraine prevention.

Safety Table

Injection site reactions include multiple related adverse event terms, such as injection site pain, injection site reaction, injection site erythema, and injection site pruritus.

<2% discontinuation rate due to treatment-related adverse events during double-blind treatment with both Emgality and placebo.1

Across 3 studies, 2 patients on Emgality discontinued due to injection site reactions1,4,5

Immunogenicity1

As with all therapeutic proteins, there is the potential for immunogenicity. Comparison of the incidence of antibodies to galcanezumab-gnlm with the incidence of antibodies in other studies or to other products may be misleading.

With 12 months of treatment in an open-label study, up to 12.5% (16/128) of Emgality-treated patients developed anti-galcanezumab-gnlm antibodies, most of whom tested positive for neutralizing antibodies.

Although anti-galcanezumab-gnlm antibody development was not found to affect the pharmacokinetics, safety, or efficacy of Emgality in these patients, the available data are too limited to make definitive conclusions.

See Instructions for Use included with the pen or prefilled syringe.

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References:

1. Emgality [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company; 2018.

2. Data on File. Lilly USA, LLC. DOF-GZ-US-0002.

3. Data on File. Lilly USA, LLC. DOF-GZ-US-0026.

4. Data on File. Lilly USA, LLC. DOF-GZ-US-0008.

5. Data on File. Lilly USA, LLC. DOF-GZ-US-0007.

Indications and Important Safety Information
Indications

Emgality is a calcitonin gene-related peptide (CGRP) antagonist indicated for the preventive treatment of migraine in adults.

Important Safety Information

CONTRAINDICATIONS
Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.


WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions (e.g., rash, urticaria, and dyspnea) have been reported with Emgality in clinical studies. If a serious or severe hypersensitivity reaction occurs, discontinue administration of Emgality and initiate appropriate therapy. Hypersensitivity reactions can occur days after administration and may be prolonged.


ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in Emgality clinical studies were injection site reactions.


Emgality is available by prescription only.


Please see Full Prescribing Information, including Patient Information for Emgality. See Instructions for Use included with the pen and prefilled syringe.


GZ HCP ISI 27SEP2018