About This Calculator

The Emgality (galcanezumab) Dosing Calculator is a clinical support tool designed for healthcare professionals to quickly determine the appropriate dosing regimen for patients. Based on the selected indication—either migraine prophylaxis or episodic cluster headache—and the treatment phase, the tool provides the specific loading and maintenance dose, administration details, and required formulation according to FDA-approved prescribing information.

Outputs

After making selections, the calculator provides a clear, concise summary of the recommended dosing protocol, including:

• Total Dose: The total dosage in milligrams (mg) for the specified phase.
• Administration: The number of subcutaneous injections required to achieve the total dose.
• Frequency: Guidance on whether the dose is a one-time loading dose or a recurring monthly maintenance dose.
• Formulation: The specific strength of the prefilled pen or syringe to be used (e.g., 120 mg/mL or 100 mg/mL).
• Clinical Notes: Important context, such as reminders about subsequent maintenance dosing schedules.

How to Use

To use the calculator, follow these simple steps:

1. Select Indication for Use: Choose either “Migraine Prophylaxis” or “Episodic Cluster Headache” based on the patient’s diagnosis.
2. Select Dosing Phase: Specify whether you are calculating the “Initial / Loading Dose” for treatment initiation or the “Monthly / Maintenance Dose” for ongoing therapy.
3. View Dosing Information: Click the “Show Dosing Information” button to generate the results. The output will appear below the input panel, providing all necessary dosing details.

Dosing Overview

Emgality dosing differs significantly based on the indication. It is administered via subcutaneous injection and is intended for patient self-administration after training. The following table summarizes the standard dosing schedules.

Switching Therapies

When switching a patient to Emgality from another CGRP inhibitor, clinical judgment is essential. A washout period is not explicitly required by the manufacturer, but the timing of the first Emgality dose should be considered in relation to the half-life and dosing schedule of the previous medication. For patients switching to Emgality, therapy should begin with the recommended loading dose for the specific indication.

Missed Dose

If a patient misses a scheduled dose of Emgality, the missed dose should be administered as soon as possible. Following the administration of the missed dose, the monthly dosing schedule should be re-established based on the new date. For example, if a dose is given on the 10th of the month, the next dose will be due on the 10th of the following month.

Safety Alerts

Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab or any of its excipients. Hypersensitivity reactions, including angioedema, urticaria, and anaphylaxis, have been reported and can occur days after administration. If a serious hypersensitivity reaction occurs, discontinue Emgality immediately and initiate appropriate therapy. The most common adverse reactions (≥2% and at least 2% greater than placebo) are injection site reactions.

Frequently Asked Questions (FAQ)

Why is the loading dose for migraine different from the maintenance dose?

The 240 mg loading dose for migraine prophylaxis is designed to rapidly achieve steady-state concentrations of galcanezumab in the body, providing therapeutic effects more quickly. The subsequent 120 mg monthly maintenance dose is sufficient to maintain these therapeutic levels.

What is the difference between the Emgality formulations?

Emgality is available in two concentrations: a 120 mg/mL prefilled pen/syringe for migraine and a 100 mg/mL prefilled syringe for episodic cluster headache. It is critical to use the correct formulation to deliver the recommended dose.

How long should a patient with episodic cluster headache continue treatment?

For episodic cluster headache, treatment with 300 mg of Emgality should be continued monthly until the end of the cluster period.

Does the calculator adjust dosing for renal or hepatic impairment?

No, because no dose adjustments are recommended for patients with renal or hepatic impairment according to the prescribing information. The calculator reflects standard dosing for the general adult population.

Where on the body can Emgality be injected?

Recommended subcutaneous injection sites are the abdomen, thigh, back of the upper arm, or buttocks. Injection sites should be rotated with each administration.

How should Emgality be stored?

Emgality should be refrigerated at 2°C to 8°C (36°F to 46°F) in its original carton to protect from light. It can be stored unrefrigerated at temperatures up to 30°C (86°F) for up to 7 days. Do not freeze.

What should a patient do before administering the injection?

The prefilled pen or syringe should be removed from the refrigerator and allowed to sit at room temperature for 30 minutes before injection. It should not be warmed by any other means, such as in a microwave or hot water.

Is it painful to administer three separate injections for the cluster headache dose?

Patients may experience injection site reactions like pain, redness, or swelling. To minimize discomfort, each of the three 100 mg injections should be administered in a different subcutaneous site.

References

This information is based on established clinical guidelines and prescribing information. For complete and detailed guidance, consult these primary sources.

• EMGALITY (galcanezumab-gnlm) Prescribing Information. U.S. Food and Drug Administration (FDA).
• Emgality (galcanezumab) Summary of Product Characteristics (SmPC). European Medicines Agency (EMA).
• Dosing & Administration for Emgality. Eli Lilly and Company.
• Stauffer VL, Dodick DW, Zhang Q, Carter JN, Ailani J, Conley RR. Evaluation of Galcanezumab for the Prevention of Episodic Migraine: The EVOLVE-1 Randomized Clinical Trial. JAMA Neurol. 2018;75(9):1080–1088.