Galcanezumab

What it is and how it works

Mechanism of Action Galcanezumab-gnlm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.

Indications

® is a calcitonin-gene related peptide antagonist indicated in adults for the: preventive treatment of migraine. treatment of episodic cluster headache. Migraine EMGALITY is indicated for the preventive treatment of migraine in adults. Episodic Cluster Headache EMGALITY is indicated for the treatment of episodic cluster headache in adults.

Dosage and administration (summary)

For subcutaneous use only. ( 2.1 , 2.2 , 2.3 ) Migraine recommended dosage: 240 mg loading dose (administered as two consecutive injections of 120 mg each), followed by monthly doses of 120 mg. Episodic cluster headache recommended dosage: 300 mg (administered as three consecutive injections of 100 mg each) at the onset of the cluster period, and then monthly until the end of the cluster period. Administer in the abdomen, thigh, back of the upper arm, or buttocks subcutaneously.

Contraindications

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

Warnings and precautions

Hypersensitivity Reactions: If a serious 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: Serious complications of constipation may occur. Hypertension: New-onset or worsening of pre-existing hypertension may occur. Raynaud's Phenomenon: New-onset or worsening of pre-existing Raynaud's phenomenon may occur.

Pregnancy

Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to EMGALITY during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-833-464-4724 or by contacting the company at www.migraine…

Storage and supply

Storage and Handling Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect EMGALITY from light until use. Do not freeze. Do not shake. EMGALITY may be stored out of refrigeration in the original carton at temperatures up to 30°C (86°F) for up to 7 days.

Source: Galcanezumab-Gnlm (Emgality) — US FDA prescribing information, 2026-06-05, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.