Across 4 clinical trials and 2 distinct doses, Emgality demonstrated a consistent safety profile in patients with migraine and in patients with episodic cluster headache1

Adverse reactions occurring in adults with migraine with an incidence of at least 2% for Emgality and at least 2% greater than placebo

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

The safety of Emgality was also evaluated for up to 2 months in a placebo-controlled study in patients with episodic cluster headache1b

Overall, the safety profile observed in patients with episodic cluster headache treated with Emgality 300 mg monthly was consistent with the safety profile in migraine patients.1

  • 2 Emgality-treated patients with episodic cluster headache discontinued double-blind treatment because of adverse events

bEmgality Episodic Cluster Headache Study: Emgality 300 mg (N=49); placebo (N=57).



Across 3 studies in patients with migraine,

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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.

Download savings cards to help eligible patients on Emgalitya

aGovernmental beneficiaries excluded.


References: 1. Emgality [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC. 2. Stauffer VL, Dodick DW, Zhang Q, et al. Evaluation of galcanezumab for the prevention of episodic migraine: the EVOLVE-1 randomized clinical trial. JAMA Neurol. 2018:75(9):1080-1088. 3. Skljarevski V, Matharu M, Millen BA, et al. Efficacy and safety of galcanezumab for the prevention of episodic migraine: results of the EVOLVE-2 Phase 3 randomized controlled clinical trial. Cephalalgia. 2018;38(8):1442-1454. 4. Data on File. Lilly USA, LLC. DOF-GZ-US-0019. 5. Data on File. Lilly USA, LLC. DOF-GZ-US-0107. 6. Data on File. Lilly USA, LLC. DOF-GZ-US-0007. 7. Data on File. Lilly USA, LLC. DOF-GZ-US-0008.

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 dyspnea, urticaria, and rash, have occurred with Emgality in clinical studies and the postmarketing setting. Cases of anaphylaxis and angioedema have also been reported in the postmarketing setting. 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 10DEC2019