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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

Adverse Reactions

The most common adverse reactions (incidence >2% and at least 2% greater than placebo) in Emgality clinical studies were injection site reactions.

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.

Hypertension
Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including Emgality, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension and, in some cases, hospitalization. Hypertension may occur at any time during treatment but was most frequently reported within 7 days of therapy initiation. Emgality was discontinued in many of the reported cases.

Monitor patients treated with Emgality for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of Emgality is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled.

Raynaud’s Phenomenon
Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including Emgality. In reported cases with monoclonal antibody CGRP antagonists, symptom onset occurred after a median of 71 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms.

Emgality should be discontinued if signs or symptoms of Raynaud’s phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in Emgality clinical studies were injection site reactions.

Emgality is an injectable prescription medicine, available as:

  • prefilled single-dose pen with 120 mg/mL solution
  • prefilled single-dose syringe with 120 mg/mL solution
  • prefilled single-dose syringe with 100 mg/mL solution

Please see Full Prescribing Information for Emgality. See Instructions for Use included with the device.

GZ HCP ISI 04APR2025

INDICATIONS

Emgality is a calcitonin gene-related peptide (CGRP) antagonist indicated in adults for the:

  • Preventive treatment of migraine
  • Treatment of episodic cluster headache