Emgality demonstrated a consistent safety profile across six Phase 3 studies in migraine and episodic cluster headache (N=3724)^1-4

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 placebo¹

EVOLVE-1, EVOLVE-2 and REGAIN (up to 6 months of treatment)

Adverse Reaction	Emgality 120 mg Monthly (N=705)	Placebo Monthly (N=1451)
Adverse Reaction: Injection site reactions^a	Emgality 120 mg Monthly (N=705): 18%	Placebo Monthly (N=1451): 13%

^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 headache^1b

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 patients treated with Emgality discontinued double-blind treatment because of adverse events

^bEmgality Episodic Cluster Headache Study: Emgality 300 mg (N=49), placebo (N=57).¹

Review study design for EVOLVE-1 and EVOLVE-2

Review study design for REGAIN

Discontinuation rates

2 patients on Emgality 120 mg discontinued due to injection site reactions

No known drug interactions

Emgality is not metabolized by CYP450 enzymes; therefore, interactions with drugs that are substrates, inducers, or inhibitors of CYP450 are unlikely¹

A pooled analysis of 3 clinical trials (EVOLVE-1, EVOLVE-2, and REGAIN) that enrolled 2886 patients showed^2,8:

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 placebo^2,8

Hypertension was reported as a likely cardiovascular treatment-emergent adverse event (TEAE) in⁸:

1.3% of patients on Emgality (n=9) vs 1.2% of patients on placebo (n=18)

Constipation was reported as an adverse reaction in^2,9:

1.0% of patients on Emgality (n=7) vs 0.6% of patients on placebo (n=8)

View efficacy for patients with episodic or chronic migraine.

TEAE	Emgality 120 mg (n=232)	Placebo (n=230)
TEAE Any Injection Site Related Adverse Event^b	Emgality 120 mg (n=232) 7%	Placebo (n=230) 10%

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

Download savings cards to help eligible patients on Emgality^c

^cGovernmental beneficiaries excluded; terms and conditions apply.

Discover what Emgality can do for your patients with 4 or more unpredictable MHDs per month¹

References:

Emgality [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC.
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.
Mulleners WM, Kim B, Láinez MJA, et al. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2020;19:814-825.
Data on File. Lilly USA, LLC. DOF-GZ-US-0107.
Data on File. Lilly USA, LLC. DOF-GZ-US-0008.
Data on File. Lilly USA, LLC. DOF-GZ-US-0007.
Data on File. Lilly USA, LLC. DOF-GZ-US-0026.
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.
Data on File. Lilly USA, LLC. DOF-GZ-US-0165.
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.
Data on File. Lilly USA, LLC. DOF-GZ-US-0137.
Data on File. Lilly USA, LLC. DOF-GZ-US-0139.
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

Emgality demonstrated a consistent safety profile across six Phase 3 studies in migraine and episodic cluster headache (N=3724)^1-4

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

The safety of Emgality was also evaluated for up to 2 months in a placebo-controlled study in patients with episodic cluster headache^1b

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

The safety profile of Emgality in the CONQUER study was consistent with the safety profile observed in 5 clinical trials^1-3

The safety of Emgality 300 mg was also evaluated for up to 2 months in a placebo-controlled study in patients with episodic cluster headache^1a

Immunogenicity¹

Emgality demonstrated a consistent safety profile across six Phase 3 studies in migraine and episodic cluster headache (N=3724)1-4

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

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

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

The safety profile of Emgality in the CONQUER study was consistent with the safety profile observed in 5 clinical trials1-3

The safety of Emgality 300 mg was also evaluated for up to 2 months in a placebo-controlled study in patients with episodic cluster headache1a

Immunogenicity1

Emgality demonstrated a consistent safety profile across six Phase 3 studies in migraine and episodic cluster headache (N=3724)^1-4

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

The safety of Emgality was also evaluated for up to 2 months in a placebo-controlled study in patients with episodic cluster headache^1b

The safety profile of Emgality in the CONQUER study was consistent with the safety profile observed in 5 clinical trials^1-3

The safety of Emgality 300 mg was also evaluated for up to 2 months in a placebo-controlled study in patients with episodic cluster headache^1a

Immunogenicity¹