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Emgality ® ▼ (galcanezumab)
This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. For current prescribing 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).
What potential drug-drug interactions does Emgality® (galcanezumab) have?
We don't expect pharmacokinetic drug interactions based on the characteristics of galcanezumab.
Contraindications and Exclusion Criteria
The concomitant use of galcanezumab and any other medications is not contraindicated, according to the Emgality Summary of Product Characteristics (SmPC).1
Please check the SmPC of all, in combination administered medications.
Patients who were taking or expected to take therapeutic antibodies during the course of the galcanezumab phase 3 studies were excluded from participating.2-6 Examples of therapeutic antibodies included
- trastuzumab, and
Other than antibodies to calcitonin gene-related peptide (CGRP) or it's receptor, the prior use of therapeutic antibodies in the galcanezumab clinical trials was allowed if
- that use was more than 12 months prior to the pre-randomization visit in the migraine prevention studies.2-6
Pharmacokinetic Characteristics of Galcanezumab
As a humanised Immunoglobulin G4 (IgG4) monoclonal antibody, galcanezumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.1
As such, it is not expected to
- inhibit metabolic or induce enzymatic pathways
- be metabolized by the cytochrome P450 families of drug-metabolizing enzymes, and
- produce any active metabolites.7-9
Drug Interaction Studies Were Not Conducted
No drug interaction studies were conducted. No pharmacokinetic drug interactions are expected based on the characteristics of galcanezumab.1
There are no known interactions for galcanezumab, drug-drug or otherwise.7
1Emgality [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2Stauffer 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
3Skljarevski 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
4Detke 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
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
6Camporeale 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
7Data on file, Eli Lilly and Company and/or one of its subsidiaries.
8Lobo ED, Hansen RJ, Balthasar JP. Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci. 2004;93(11):2645-2668. https://doi.org/10.1002/jps.20178
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: 25 January 2022