What is the recommended dosage and administration of Emgality (galcanezumab) for cluster headache treatment?

From the Guidelines

For cluster headache treatment, Emgality (galcanezumab) is administered as three consecutive subcutaneous injections of 100 mg each (total 300 mg) at the onset of a cluster period, and then monthly until the end of the cluster period. This recommendation is based on the most recent and highest quality study available, although the provided studies do not directly address the use of Emgality for cluster headache treatment 1.

Key Administration Details

• The medication comes in single-dose prefilled pens or syringes containing 100 mg/mL.
• Patients can self-administer these injections in the abdomen, thigh, back of the upper arm, or buttocks after proper training.
• The injections should be stored refrigerated but allowed to reach room temperature for 30 minutes before injection.
• No dose adjustments are needed for age, gender, weight, or kidney/liver function.

Mechanism and Side Effects

• Emgality works by binding to calcitonin gene-related peptide (CGRP), blocking its activity and preventing the vasodilation and neurogenic inflammation associated with cluster headaches.
• Common side effects include injection site reactions, and patients should be monitored for hypersensitivity reactions.

Treatment Initiation

• Treatment should be initiated as early as possible when a cluster period begins for maximum effectiveness. It's essential to note that while the provided evidence does not directly address Emgality's use for cluster headaches, the recommended administration and dosage are based on the general understanding of the medication's use in similar contexts, prioritizing patient safety and efficacy.

From the FDA Drug Label

2.2 Recommended Dosing for Episodic Cluster Headache The recommended dosage of EMGALITY is 300 mg (three consecutive subcutaneous injections of 100 mg each) at the onset of the cluster period, and then monthly until the end of the cluster period.

To write a prescription for Emgality for cluster headache, the recommended dosage is 300 mg administered as three consecutive subcutaneous injections of 100 mg each at the onset of the cluster period, followed by monthly doses until the end of the cluster period 2.

• The dose should be administered subcutaneously in the abdomen, thigh, back of the upper arm, or buttocks.
• It is essential to provide proper training to patients and/or caregivers on how to prepare and administer Emgality using the single-dose prefilled pen or single-dose prefilled syringe.

From the Research

Emgality (Galcanezumab) for Cluster Headache Treatment

• Emgality (galcanezumab) is a humanized monoclonal antibody to calcitonin gene-related peptide, which may be a preventive treatment for cluster headache 3.
• The recommended dosage of Emgality for cluster headache treatment is 300 mg, administered subcutaneously at baseline and at 1 month 3.
• Emgality has been shown to reduce the weekly frequency of cluster headache attacks across weeks 1 through 3 after the initial injection, as compared with placebo 3.
• The percentage of patients who had a reduction of at least 50% in headache frequency at week 3 was 71% in the galcanezumab group, as compared with 53% in the placebo group 3.

Administration and Usage

• Emgality is administered subcutaneously, and the majority of patients used a dose of 300 mg once monthly 4.
• There was a reduction in headache frequency of ≥ 50% at 3 weeks in 65.9% of patients for all doses of galcanezumab, and in 72.4% of those using galcanezumab 300 mg 4.
• Galcanezumab is recommended as a preventive treatment for episodic cluster headache, and may be considered as an alternative treatment for chronic cluster headache 5.

Clinical Guidelines and Expert Consensus

• The European Academy of Neurology guidelines recommend galcanezumab as an alternative treatment for cluster headache, with a strong recommendation for oxygen and subcutaneous sumatriptan for acute treatment, and verapamil for prophylaxis 5.
• A survey of Brazilian experts recommended galcanezumab as either the first or the second option in prophylaxis, highlighting its promising efficacy as a new tool in cluster headache patients 4.