Safety


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

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

  • 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.

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.

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.

Indications and Important Safety Information
Indications

Emgality is a calcitonin gene-related peptide (CGRP) antagonist indicated in adults for the:

  • Preventive treatment of migraine
  • Treatment of episodic cluster headache

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, including anaphylaxis, angioedema, dyspnea, urticaria, and rash, have been reported with Emgality. 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.


Please see Full Prescribing Information, including Patient Information, for Emgality. See Instructions for Use included with the device.


GZ HCP ISI 04JUN2019