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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 a patient be vaccinated during Emgality® ▼ (galcanezumab) treatment?
The concomitant use of galcanezumab and vaccinations has not been studied, but it is not contraindicated. Galcanezumab is not anticipated to interact with the host immune system, nor have any drug interactions.
UK_cFAQ_GLC006_IMMUNIZATION
en-GB
Concomitant Vaccine Use in Galcanezumab Clinical Trial
Eli Lilly and Company have not evaluated the safety and efficacy of galcanezumab in combination with vaccines.
The use of vaccines with galcanezumab is not contraindicated.1
Based on the mechanism of action, the mechanism of elimination, and the characteristics of galcanezumab, there is no reason to expect an interaction
- with the host immune system or
- with galcanezumab and other drugs. 1
The decision to administer a vaccination to a patient before, 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.
In the phase 3 clinical studies, patients received vaccines during double-blind, placebo-controlled, and open-label galcanezumab treatment; however, subgroup analyses were not completed in this population.1
Vaccines Administered During Phase 3 Migraine Prevention Clinical Trials
Vaccine usage was low overall in the phase 3 migraine prevention studies.1 The influenza vaccine was the most commonly administered vaccine during galcanezumab treatment, with reported usage in 1.26% to 2.82% of patients receiving galcanezumab.
Other vaccines administered to at least 1 galcanezumab-treated patient included
- anthrax
- hepatitis
- human papilloma
- meningococcal
- pneumococcal
- tetanus
- tick-borne encephalitis, and
- varicella zoster.1
Subgroup analyses were not completed in this population.
References
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Glossary
CGRP = calcitonin gene-related peptide
IgG4 = immunoglobulin G (subclass) 4
mAb = monoclonal antibody
▼ 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: 19 July 2021
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