Emgality® ▼ (galcanezumab)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Emgality Summary of Product Characteristics (SmPC)

How should a missed or incomplete loading dose of Emgality® ▼ (galcanezumab) be managed?

In the event of a missed or incomplete loading dose of galcanezumab, complete the loading dose as soon as possible. Then continue with the monthly maintenance dose from the date of last dose.

Management of Missed or Incomplete Galcanezumab Loading Dose

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.1

Patients should be instructed to inject a missed dose as soon as possible and then resume monthly dosing.1

Pharmacokinetic Considerations

In healthy subjects and patients with episodic or chronic migraine, galcanezumab has a

  • Tmax of 5 days, and

  • t1/2 of 27 days.1,2

Pharmacokinetic modeling of phase 3 data confirmed that

  • the 240 mg loading dose achieved steady-state galcanezumab concentrations by month 1 for the 120 mg monthly dose regimen, and

  • without a loading dose, the 120 mg monthly dose did not achieve steady state until 4 to 5 months.3 

References

1. Emgality [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Kielbasa W, Helton DL. A new era for migraine: Pharmacokinetic and pharmacodynamic insights into monoclonal antibodies with a focus on galcanezumab, an anti-CGRP antibody. Cephalalgia. 2019;39(10):1284-1297. http://dx.doi.org/10.1177/0333102419840780

3. Kielbasa W,Quinlan T. Population pharmacokinetics of galcanezumab, an anti-CGRP antibody, following subcutaneous dosing to healthy individuals and patients with migraine. J Clin Pharmacol. 2020;60(2):229-239. http://dx.doi.org/10.1002/jcph.1511

Glossary

t1/2 = elimination half-life

Tmax = time of maximum observed drug concentration

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Date of Last Review: June 05, 2020

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