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

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

    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

    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