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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).
Can patients treated with Emgality® (galcanezumab) receive a COVID-19 vaccine?
The use of vaccines against SARS-CoV-2 in patients treated with galcanezumab has not been studied. Based on the mechanism of action and mechanism of elimination of galcanezumab, there is no reason to expect an interaction with the host immune system.
Administration of COVID-19 Vaccines to Patients Receiving Galcanezumab
Vaccines to prevent coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), are available.1
The use of a COVID-19 vaccine, including boosters, in patients treated with galcanezumab has not been studied by Eli Lilly and Company (Lilly).
Lilly has not evaluated the safety and efficacy of galcanezumab in combination with vaccines, including COVID-19 vaccines.
An interaction with the host immune system is not expected based on the mechanism of action and mechanism of elimination of galcanezumab.
The decision to administer a vaccination to a patient prior to, during, or after galcanezumab treatment must be based on the clinical judgment of the prescribing healthcare practitioner after careful consideration of the patient's risk factors as well as the risks and benefits of vaccination.
Please follow local guidance regarding vaccine schedules and recommendations.
Calcitonin Gene-Related Peptide Monoclonal Antibodies Have No Direct Specific Immunomodulatory Effect
The calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) have been engineered to bind to either the CGRP peptide or receptor with high specificity and minimized interaction with the immune system.2-4 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.5
References
1Coronavirus disease (COVID-19): vaccines. World Health Organization (WHO). October 28, 2020. Accessed August 31, 2021. https://www.who.int/news-room/q-a-detail/coronavirus-disease-(covid-19)-vaccines?topicsurvey=v8kj13)&gclid=EAIaIQobChMIzI7e0-jb8gIV421vBB2JsQHYEAAYASAAEgKEAfD_BwE
2Raffaelli 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
3Silberstein 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
4Levin 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
5Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: 27 August 2021