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)

Can Emgality®▼ (galcanezumab) and Botox® be used concomitantly?

Concomitant use of botulinum toxin with galcanezumab has not been studied.

Clinical Study and Use of Botulinum Toxin A or B

Treatment with botulinum toxin A or B administered to the head or neck area was required to be discontinued at least 4 months prior to entering the prospective baseline or baseline period in

  • all galcanezumab phase 3 chronic or episodic migraine prevention clinical trials,1-3 and

  • the phase 2 proof-of-concept and migraine prevention trials.4,5

As such, the use of Botox with galcanezumab has not been studied.

Other CGRP Monoclonal Antibodies Used With Botox

A search of the literature found 1 small study (N=158) that included some information on the concomitant use of a CGRP monoclonal antibody in combination with Botox.6 This study evaluated the add-on of erenumab to Botox, oral migraine preventives, or erenumab alone in patients with chronic migraine who have failed >3 prior preventives. The authors of this study concluded that in the population studied, erenumab as an add-on to a preventive therapy was more efficacious than erenumab alone, and that the add-on to Botox was more effective than add-on to oral preventives.

Galcanezumab Mechanism of Action

Galcanezumab is a humanized IgG4 mAb that

  • binds CGRP, and

  • prevents its biological activity without blocking the CGRP receptor.7 

Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.8

Botox Mechanism of Action

BOTOX blocks the release of neurotransmitters associated with the genesis of pain. The presumed mechanism for headache prophylaxis is by blocking peripheral signals to the central nervous system, which inhibits central sensitisation, as suggested by pre-clinical and clinical pharmacodynamic studies.9

Botox is indicated for prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine).9 

Please refer to the manufacturer's prescribing information for additional information about Botox.

References

1. Stauffer 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

2. Skljarevski 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

3. Detke 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

4. Skljarevski V, Oakes TM, Zhang Q, et al. Effect of different doses of galcanezumab vs placebo for episodic migraine prevention: a randomized clinical trial. JAMA Neurol. 2018;75(2):187-193. http://dx.doi.org/10.1001/jamaneurol.2017.3859

5. Dodick DW, Goadsby PJ, Spierings EL, et al. Safety and efficacy of LY2951742, a monoclonal antibody to calcitonin gene-related peptide, for the prevention of migraine: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2014;13(9):885-892. http://dx.doi.org/10.1016/S1474-4422(14)70128-0

6. Boudreau GP, Demers C. Treatment of chronic migraine with erenumab alone or as an add on therapy; a real world prospective observational study. Talk presented at: Congress of the International Headache Society; September 5-8, 2019; Dublin, Ireland.

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.

9. Botox [summary of product characteristics]. Allergan Limited Marlow International The Parkway, Marlow, UK - accessed on 20/08/2020

Glossary

BOTOX® = onabotulinumtoxinA

CGRP = calcitonin gene-related peptide

Ig = immunoglobulin

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: April 09, 2020

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