CGRP is thought to play a central role in migraine pathogenesis6

Elevated levels of calcitonin gene-related peptide (CGRP) can lead to a cascade of vasodilation and pain associated with migraine attacks, as observed in preclinical studies of CGRP6

  • CGRP, released from the trigeminal ganglia, is elevated during migraine6
  • An infusion of CGRP can induce migraine attacks in susceptible individuals, and CGRP is involved in the transmission of pain7,8
  • Perivascular release of CGRP has been shown to induce vasodilation and plasma protein leakage from tissues6
Emgality CGRP Receptor image

References: 1. Diamond S, Bigal ME, Silberstein S, et al. Patterns of diagnosis and acute and preventive treatment for migraine in the United States: results from the American Migraine Prevalence and Prevention study. Headache. 2007;47:355-363. 2. Lipton RB, Bigal ME, Diamond M, et al; for the AMPP Advisory Group. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68:343-349. 3. Data on File. Lilly USA, LLC. DOF-GZ-US-0028. 4. US Census Bureau. Quick facts. https://www.census.gov/quickfacts/fact/table/US/PST045217. Accessed January 12, 2019. 5. Lipton RB, Bigal ME, Kolodner K, et al. The family impact of migraine: population-based studies in the USA and UK. Cephalalgia. 2003;23:429-440. 6. Durham PL. CGRP-receptor antagonists—A fresh approach to migraine therapy? N Engl J Med. 2004;350(11):1073-1075. 7. Lassen LH, Haderslev PA, Jacobsen VB, et al. CGRP may play a causative role in migraine. Cephalalgia. 2002;22:54-61. 8.Oku R, Satoh M, Fujii N, et al. Calcitonin gene-related peptide promotes mechanical nociception by potentiating release of substance P from the spinal dorsal horn in rats. Brain Res. 1987;403:350-354.

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