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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).
Can Emgality® (galcanezumab) be used in patients with multiple sclerosis?
Multiple sclerosis is not a contraindication to using galcanezumab. While patients with multiple sclerosis were not excluded from clinical trials, no subgroup analyses have been conducted due to the small number of patients with this comorbidity.
Additional Information on Use in Patients With Comorbid Multiple Sclerosis
Clinicians should use their clinical judgment and consult the label information of concomitant multiple sclerosis medications to determine the most appropriate approach in treating a patient with galcanezumab who has comorbid multiple sclerosis.
Galcanezumab Is Not Associated With Increased Risk of Infection or Immunosuppression
The calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) have been engineered to bind to either the CGRP peptide or receptor with high specificity and minimized interaction with the immune system.1-3 As CGRP is not an immune system target, CGRP mAbs have no direct immunomodulatory effect.
The use of galcanezumab is not associated with increased risk of infections or immunosuppression, nor are such events identified as important risks in the galcanezumab risk management plan.4
Comorbid Multiple Sclerosis as a Preexisting Condition in Galcanezumab Clinical Trials
Patients with multiple sclerosis were not explicitly excluded from the phase 3 studies.4
However, patients were excluded from participation in the phase 3 studies if they had a history or presence of any medical illness including neurologic disorders, or any clinically significant laboratory abnormality, that in the judgment of the investigator, indicated a medical problem that would preclude study participation.4
There were 3 galcanezumab-treated patients in the phase 3 studies who reported the preexisting condition of multiple sclerosis. No subgroup analysis was done on this population.4
There are no known interactions for galcanezumab, drug-drug or otherwise.4
1Raffaelli B, Reuter U. The biology of monoclonal antibodies: focus on calcitonin gene-related peptide for prophylactic migraine therapy. Neurotherapeutics. 2018;15(2):324-335. http://dx.doi.org/10.1007/s13311-018-0622-7
2Silberstein S, Lenz R, Xu C. Therapeutic monoclonal antibodies: what headache specialists need to know. Headache. 2015;55(8):1171-1182. http://dx.doi.org/10.1111/head.12642
3Levin M, Silberstein SD, Gilbert R, et al. Basic considerations for the use of monoclonal antibodies in migraine. Headache. 2018;58(10):1689-1696. http://dx.doi.org/10.1111/head.13439
4Data on file, Eli Lilly and Company and/or one of its subsidiaries.
▼ 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: 30 August 2021