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The safety of Emgality was evaluated in a large clinical trial program in migraine prevention1

The most frequent adverse reactions in the EVOLVE-1, EVOLVE-2, and REGAIN clinical trials with Emgality were injection site reactions1a

Adverse Reactions Occurring in Adults With Migraine With an Incidence of at Least 2% for Emgality and at Least 2% Greater Than Placebo (up to 6 Months of Treatment) in EVOLVE-1, EVOLVE-2, and REGAIN1

Adverse Reaction Emgality 120 mg (N=705) Placebo (N=1451)
Injection site reactionsa 18% 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.

Across 3 studies (EVOLVE-1, EVOLVE-2, and REGAIN):

  • 2 patients on Emgality 120 mg discontinued due to injection site reactions2-3
  • <2% of patients on Emgality 120 mg discontinued double-blind treatment due to adverse events1,4

See the full Instructions for Use included with your device.

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

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 with the frequency of injection site reactions reported at 16% for Emgality.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

No known drug interactions

Emgality is not metabolized by CYP450 enzymes; therefore, interactions with drugs that are substrates, inducers, or inhibitors of CYP450 are unlikely.1

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

CYP450=cytochrome P450.

View results from a 12-month, open-label safety study of patients with migraine.

See study designs for EVOLVE-1, EVOLVE-2, and REGAIN.

See study design for 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.

References

  1. Emgality. Prescribing Information. Lilly USA, LLC.
  2. Data on File. Lilly USA, LLC. DOF-GZ-US-0008.
  3. Data on File. Lilly USA, LLC. DOF-GZ-US-0007.
  4. Data on File. Lilly USA, LLC. DOF-GZ-US-0026.

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