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Emgality ® ▼ (galcanezumab)
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What is Emgality® ▼ (galcanezumab) recommended dosing and administration for migraine prevention?
The recommended dose is 120 mg injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose. A 240 mg loading dose allows galcanezumab concentrations to reach a steady state by month 1.
Dose administration in phase 3 migraine prevention studies
In the phase 3 migraine-prevention clinical trials,1-3 dosing visits were scheduled at 30-day intervals.1-5 Subcutaneous injections were allowed to be administered within ±2 days of the scheduled visit.6
Please note that a maintenance dose of 240 mg galcanezumab once monthly is not approved and therefore not recommended.
The galcanezumab Cmax, ss at monthly doses of 120 mg is achieved after the 240 mg loading dose.7
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.8
Loading dose rationale of 240 mg galcanezumab
A pharmacodynamic model relating galcanezumab concentrations to reductions in migraine headache days was developed to predict dose-effect relationship of galcanezumab across various monthly dose regimens including
The model results showed that the use of galcanezumab 120 mg/month with a 240-mg loading dose showed a mean predicted change from baseline in migraine headache days similar to the 240 mg/month dose.6,9
A galcanezumab dose
- less than 120 mg/month was predicted to not have robust clinical efficacy, and
- greater than 240 mg/month was predicted to have a robust clinical effect similar to the 240 mg/month dose.9
These results were used to support the use of a 240-mg loading dose for the 120 mg/month dose group to achieve steady-state galcanezumab concentrations after the first dose.9
1Detke 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
2Skljarevski 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
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
4Camporeale A, Kudrow D, Sides R, et al. A phase 3, long-term, open-label safety study of galcanezumab in patients with migraine. BMC Neurol. 2018;18(1):188. http://dx.doi.org/10.1186/s12883-018-1193-2
5Mulleners 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
6Data on file, Eli Lilly and Company and/or one of its subsidiaries.
7Emgality [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
8Kielbasa 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
9Kielbasa 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
▼ 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: 28 September 2020