Skip to main content

In a 12-month, open-label safety study of patients with episodic or chronic migraine with 4 or more MHDs per month,

No new safety findings were identified for Emgality over a 12-month treatment period.1 TEAEs were predominantly rated as mild or moderate in severity.2

  • 54 patients on Emgality 120 mg experienced a TEAE possibly related to study treatment during the 12-month treatment period. The most prevalent TEAEs were injection site pain, injection site reaction, and injection site erythema1,2
  • 6 patients discontinued Emgality 120 mg due to adverse events; 2 patients discontinued due to injection site reaction, 1 patient discontinued due to injection site erythema, and 1 patient discontinued due to lethargy. Other discontinuations due to adverse events were not determined to be related to study treatment1-3
  • Of the 54 TEAEs possibly related to study treatment, 27 were deemed mild, 21 were deemed moderate, and 6 were deemed severe4

See study design for a 12-month, open label safety study.

MHD=migraine headache day; TEAE=treatment-emergent adverse event.

References

  1. Camporeale A, Kudrow D, Sides R, et al. A phase 3, long-term, open-label safety study of galcanezumab in patients with migraine. BMC Neurol. 2018;18(1):188.
  2. Data on File. Lilly USA, LLC. DOF-GZ-US-0137.
  3. Data on File. Lilly USA, LLC. DOF-GZ-US-0139.
  4. Data on File. Lilly USA, LLC. DOF-GZ-US-0140.

IMPORTANT SAFETY INFORMATION

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

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.

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 14SEP2022

INDICATIONS

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

  • Preventive treatment of migraine
  • Treatment of episodic cluster headache