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Emgality works differently than many other preventive medications1-3

Emgality is a humanized monoclonal antibody specficially developed to bind to CGRP1

Binding of CGRP molecule

There are no relevant data on the pharmacodynamic effects of galcanezumab-gnlm.1

SELECT IMPORTANT SAFETY INFORMATION

Constipation With Serious Complications

Constipation with serious complications has been reported following the use of monoclonal antibody CGRP antagonists, including EMGALITY, in the postmarketing setting. There were cases with monoclonal antibody CGRP antagonists that required hospitalization, including cases where surgery was necessary. In a majority of these cases, the onset of constipation was reported after the first dose; however, patients have also presented with constipation later on in treatment. The monoclonal antibody CGRP antagonist was discontinued in many of the reported cases of constipation with serious complications.

Monitor patients treated with EMGALITY for severe constipation and manage as clinically appropriate. The concurrent use of medications that reduce gastrointestinal motility may increase the risk for more severe constipation and the potential for constipation-related complications.

CGRP is thought to play a key role in migraine4

Elevated levels of CGRP can lead to a cascade of vasodilation and pain associated with migraine attacks, as observed in preclinical studies of CGRP.4

CGRP molecule binding to receptor
  • CGRP, released from the trigeminal ganglia, is elevated during migraine attacks4
  • Perivascular release of CGRP has been shown to induce vasodilation and plasma protein leakage from tissues4
  • An infusion of CGRP can induce migraine attacks in susceptible individuals, and CGRP is involved in the transmission of pain5,6

CGRP=calcitonin gene-related peptide.

References

  1. Emgality. Prescribing information. Lilly USA, LLC.
  2. Russo AF. Calcitonin gene-related peptide (CGRP): a new target for migraine. Annu Rev Pharmacol Toxicol. 2015;55:533-552.
  3. Garza I, Swanson JW. Prophylaxis of migraine. Neuropsychiatr Dis Treat. 2006;2(3):281-291.
  4. Durham PL. CGRP-receptor antagonists—A fresh approach to migraine therapy? N Engl J Med. 2004;350(11):1073-1075.
  5. Lassen L, Haderslev P, Jacobsen V, et al. CGRP may play a causative role in migraine. Cephalalgia. 2002;22:54-61.
  6. Oku R, Satoh M, Fujii N, et al. Calcitonin gene-related peptide promotes mechanical nociception by potentiating release of substance P from the spinal dorsal horn in rats. Brain Research. 1987;403(2):350-354.

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.

Constipation with Serious Complications
Constipation with serious complications has been reported following the use of monoclonal antibody CGRP antagonists, including EMGALITY, in the postmarketing setting. There were cases with monoclonal antibody CGRP antagonists that required hospitalization, including cases where surgery was necessary. In a majority of these cases, the onset of constipation was reported after the first dose; however, patients have also presented with constipation later on in treatment. The monoclonal antibody CGRP antagonist was discontinued in many of the reported cases of constipation with serious complications.

Monitor patients treated with EMGALITY for severe constipation and manage as clinically appropriate. The concurrent use of medications that reduce gastrointestinal motility may increase the risk for more severe constipation and the potential for constipation-related complications.

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 22JUN2026

INDICATIONS

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

  • Preventive treatment of migraine
  • Treatment of episodic cluster headache