Emgality ® ▼ (galcanezumab)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Emgality Summary of Product Characteristics (SmPC)

Emgality®▼(galcanezumab): Use with COVID-19 Vaccines

The use of vaccines against SARS-CoV-2 in patients treated with galcanezumab has not been studied by Lilly.

Administration of COVID-19 Vaccines to Patients Receiving Galcanezumab

SARS-CoV-2 Virus

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an emerging virus that has caused the recent COVID-19 pandemic. Currently, efforts are underway to develop vaccines against SARS-CoV-2 and these vaccines are expected to be available in the coming months.1,2

SARS-CoV-2 Live vs Nonlive or Inactivated Vaccines

According to current available information on SARS-CoV-2 vaccines being developed, the majority are nonlive.3 However, this is an unprecedented and evolving situation, so it is advisable to check for updated information. For the most up-to-date information regarding each vaccine in development, including the type of each vaccine, please check the World Health Organization and European Medicines Agency at

https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines and

https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/covid-19-vaccines-key-facts

Confirmation of whether a specific vaccination is live vs nonlive/inactivated can also be found in the manufacturer’s product labeling.

Immunization Prior to or During Therapy With Galcanezumab

The use of a SARS-CoV-2 vaccine in patients treated with galcanezumab has not been studied by Lilly. 

Eli Lilly and Company has not evaluated the safety and efficacy of galcanezumab in combination with vaccines, including SARS-CoV2 vaccines.

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. 

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. 

CGRP mAbs Have no Direct Specific Immunomodulatory Effect

The CGRP mAbs have been engineered to bind to either the CGRP peptide or receptor with high specificity and minimized interaction with the immune system.4-6 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.7,8

References

1. Dong Y, Dai T, Wei Y, et al. A systematic review of SARS-CoV-2 vaccine candidates. Signal Transduct Target Ther. 2020;5(1):237. http://dx.doi.org/10.1038/s41392-020-00352-y

2. Jackson LA, Anderson EJ, Rouphael NG, et al. An mRNA vaccine against SARS-CoV-2 - preliminary report. N Engl J Med. 2020;383(20):1920-1931. http://dx.doi.org/10.1056/NEJMoa2022483

3. Draft landscape of COVID-19 candidate vaccines. World Health Organization (WHO). November 12, 2020. Accessed December 4, 2020. https://www.who.int/docs/default-source/blue-print/novel-coronavirus-landscape-covid-19-(7).pdf?sfvrsn=a4e55ae3_2&download=true

4. Raffaelli 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

5. Silberstein 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

6. Levin 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

7. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

8. Emgality [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Glossary

CGRP = calcitonin gene-related peptide

COVID-19 = coronavirus disease 2019

Lilly = Eli Lilly and Company

mAb = monoclonal antibody

SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2

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: December 10, 2020


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