Emgality demonstrated a consistent safety profile across five Phase 3 studies in migraine and episodic cluster headache (N=3262)1-7

The most frequent adverse reactions with Emgality in the EVOLVE-1, EVOLVE-2, and REGAIN clinical trials were injection site reactions1

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 asinjection site pain, injection site reaction, injection site erythema, and injection sitepruritus.

Review study design for EVOLVE-1 and EVOLVE-2
Review study design for REGAIN

The safety of Emgality was evaluated in >2500 patients with migraine across 3 clinical trials1

Discontinuation rates

2 patients on Emgality 120 mg discontinued due to injection site reactions
<2% discontinued due to adverse events

A pooled analysis of 3 clinical trials (EVOLVE-1, EVOLVE-2, and REGAIN) that enrolled 2886 patients showed7,11:

Hypertension rates were below 1.4% for patients on Emgality 120 mg and placebo, and constipation rates were 1.0% for patients on Emgality 120 mg vs 0.6% for patients on placebo7,11

Hypertension was reported as a likely cardiovascular treatment-emergent adverse event (TEAE) in11:

Rates of hypertension

Constipation was reported as an adverse reaction in7,12:

Rates of constipation

View efficacy for patients with episodic or chronic migraine.

Lilly continues to monitor the safety data of Emgality in the general population.

Download savings cards to help eligible patients on Emgalitya

aGovernmental beneficiaries excluded; terms and conditions apply.


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. Detke HC, Goadsby PJ, Wang S, et al. Galcanezumab in chronic migraine: the randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018;91(24):e2211-e2221. 5. Data on File. Lilly USA, LLC. DOF-GZ-US-0107. 6. 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. doi:10.1186/s12883-018-1193-2. 7. Bangs ME, Kudrow D, Wang S, et al. Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies. BMC Neurol. 2020;20:90. doi:10.1186/s12883-020-1609-7. 8. Data on File. Lilly USA, LLC. DOF-GZ-US-0008. 9. Data on File. Lilly USA, LLC. DOF-GZ-US-0007. 10. Data on File. Lilly USA, LLC. DOF-GZ-US-0026. 11. Oakes TM, Kovacs R, Rosen N, et al. Evaluation of cardiovascular outcomes in adult patients with episodic or chronic migraine treated with galcanezumab: data from three phase 3, randomized, double-blind, placebo-controlled EVOLVE-1, EVOLVE-2, and REGAIN studies. Headache. 2020;60:110-123. 12. Data on File. Lilly USA, LLC. DOF-GZ-US-0165. 13. Data on File. Lilly USA, LLC. DOF-GZ-US-0137. 14. Data on File. Lilly USA, LLC. DOF-GZ-US-0139. 15. Data on File. Lilly USA, LLC. DOF-GZ-US-0140.

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