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In a study of patients with episodic and chronic migraine who experienced 2-4 prior preventive category failures,

The safety profile of Emgality in the CONQUER study was consistent with the safety profile observed in 4 clinical trials1-3

TEAEsa Over Months 1 to 3

TEAE Emgality 120 mg (n=232) Placebo (n=230)
Any Injection Site Related Adverse Eventb 7% 10%
  • 1 patient on Emgality discontinued due to an adverse event considered indicative of hypersensitivity. There were no clinically meaningful differences in laboratory parameters, vital signs, weight, or ECG parameters between treatment groups1

aTEAEs are those adverse drug reactions previously identified in phase 3 migraine prevention studies. Anaphylaxis, angioedema, and rash have been identified as adverse drug reactions in post-marketing use.1

bInjection site related adverse events included erythema, pain, pruritus, edema, discoloration, hypersensitivity, induration, paresthesia, swelling, bruising, hematoma, and reaction.1

See study design for CONQUER.

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

See safety data for EVOLVE-1 and 2, REGAIN, and episodic cluster headache.

SELECT IMPORTANT SAFETY INFORMATION

Contraindications

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

ECG=electrocardiogram; TEAE=treatment-emergent adverse event.

References

  1. Mulleners WM, Kim BK, 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(10):814-825.
  2. Emgality. Prescribing information. Lilly USA, LLC.
  3. 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.

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