Safety
Safety evaluated across three Phase 3 trials1,2
The safety of Emgality was assessed in a large clinical trial program in migraine prevention.
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.