Tips for searching:
• You have to select a product and type at least 2 words to activate the search
• Use only words that are specific to the information you are looking for
• Avoid typing questions or sentences
Please do not use this field to report adverse events or product complaints. Adverse events and product complaints should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow card in the Google play or Apple app store. Adverse events and product complaints should also be reported to Lilly: please call Lilly UK on 01256 315 000.
Emgality ® (galcanezumab)
This information is intended for UK registered healthcare professionals only in response to your search for information. For current information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).
Should Emgality® (galcanezumab) loading dose be repeated following missed doses or treatment interruption?
From a pharmacokinetic perspective, consider repeating a loading dose if 3 consecutive monthly doses are missed.
How are missed or delayed galcanezumab doses managed?
Patients should be instructed to
Dose Administration and Timing Parameters in Phase 3 Migraine Prevention Studies
Galcanezumab has been studied in phase 3 randomized, double-blind, placebo-controlled studies in adult patients for the prevention of
In the phase 3 clinical trials, injections were allowed to be administered within ±2 days of the scheduled visit.7
The recommended dose is 120 mg injected subcutaneously once monthly, with a 240-mg loading dose as the initial dose.1
Considerations for Repeating a Loading Dose After Missed Doses
The pharmacokinetic (PK) profile of galcanezumab enables some flexibility with regard to when doses are administered. Prolonged dosing delays will
- decrease galcanezumab concentrations, and
- potentially reduce efficacy.7
It may require some time to re-establish steady-state galcanezumab plasma concentrations when dosing is resumed. To determine whether a repeat loading dose is warranted, please consider the
- elimination half-life (t1/2), and
- other PK characteristics of galcanezumab.
In healthy subjects and patients with episodic or chronic migraine, galcanezumab has a
Steady-state concentrations are achieved by month 1 for the 120-mg monthly dose with a 240-mg loading dose.8
After missing 3 consecutive monthly doses, approximately 12% of the galcanezumab concentration relative to steady state will be remaining (Effect of Missed Monthly Doses on Galcanezumab Steady-State Concentrations).7
Therefore, after missing 3 consecutive monthly doses, repeating a loading dose should be considered from a PK perspective.
Clinicians should use their judgment to determine whether a repeat loading dose is needed.
Management of Missed or Incomplete Loading Dose
The galcanezumab steady-state Cmax (Cmax, ss) at monthly doses of 120 mg is achieved after the 240 mg loading dose.1
References
1Emgality [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2Emgality [package leaflet]. Eli Lilly Nederland B.V., The Netherlands.
3Stauffer VL, Dodick DW, Zhang Q, et al. Evaluation of galcanezumab for the prevention of episodic migraine: the EVOLVE-1 randomized clinical trial. JAMA Neurol. 2018;75(9):1080-1088. http://dx.doi.org/10.1001/jamaneurol.2018.1212
4Skljarevski V, Matharu M, Millen BA, et al. Efficacy and safety of galcanezumab for the prevention of episodic migraine: results of the EVOLVE-2 phase 3 randomized controlled clinical trial. Cephalalgia. 2018;38(8):1442-1454. http://dx.doi.org/10.1177/0333102418779543
5Detke HC, Goadsby PJ, Wang S, et al. Galcanezumab in chronic migraine: the randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018;91(24):e2211-e2221. http://dx.doi.org/10.1212/WNL.0000000000006640
6Mulleners WM, Kim BK, Láinez MJA, et al. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2020;19(10):814-825. http://dx.doi.org/10.1016/S1474-4422(20)30279-9
7Data on file, Eli Lilly and Company and/or one of its subsidiaries.
8Kielbasa 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
9Kielbasa 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
Date of Last Review: 12 May 2022