The safety of Emgality was evaluated for up to 2 months in a placebo-controlled study in patients with episodic cluster headache1
Overall, the safety profile observed in patients with episodic cluster headache treated with Emgality 300 mg monthly is consistent with the safety profile in migraine patients.1
- Two Emgality-treated patients discontinued double-blind treatment because of adverse events1
In EVOLVE-1, EVOLVE-2, and REGAIN, the adverse reaction occurring in adults with migraine with an incidence of at least 2% for Emgality and at least 2% greater than placebo (up to 6 months of treatment) was injection site reactionsa: 18% for Emgality 120 mg (N=705) and 13% for placebo (N=1451).1
- In the Emgality Episodic Cluster Headache Study, no serious adverse events were reported during the double-blind treatment period2
If a serious or severe hypersensitivity reaction occurs, discontinue administration of Emgality and initiate appropriate therapy.
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.
In controlled studies with Emgality up to 6 months (EVOLVE-1, EVOLVE-2, and REGAIN), the incidence of anti-galcanezumab-gnlm antibody development was 4.8% (33/688) in patients receiving Emgality once monthly. 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.
References: 1. Emgality [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC. 2. Data on File. Lilly USA, LLC. DOF-GZ-US-0069.