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): Switching From Another Migraine Preventive Medication

There are no systematically collected data to address how to switch patients from other migraine preventive medications to galcanezumab.

Guidance From Headache Professional Organizations on Incorporating New Migraine Preventive Agents

While there are no systematically collected data to address how to switch patients from other migraine preventive medications to galcanezumab, the European Headache Federation1 and the American Headache Society2 have issued guidance for practitioners summarized in Table 1.

Table 1. Management of Other Preventives When Using CGRP mAbs in Patients With Migraine

 

EHF Recommendations1

AHS Consensus Statement2

Episodic Migraine

Stop oral preventive medications prior to initiating therapy with anti-CGRP mAbs

Add anti-CGRP mAb therapy to existing preventive treatment; make no further changes until efficacy of anti-CGRP mAb has been determined. 

Chronic Migraine

Add anti-CGRP mAb to existing oral preventive treatment and reassess need to withdraw oral preventive treatment.a

 

In patients treated with onabotulinumtoxinA who do not have an adequate response, discontinue onabotulinumtoxinA before initiating treatment with anti-CGRP mAb.

 

In patients treated with an anti-CGRP mAb who may benefit from additional prevention, add oral preventive to anti-CGRP mAb therapy.

Abbreviations: AHS = American Headache Society; CGRP = calcitonin gene-related peptide; EHF = European Headache Federation; mAb = monoclonal antibody.

a Guidance applies to patients with chronic migraine as well as patients with a history of chronic migraine.

Switching From Another Migraine Preventive Medication

The following information summarizes exclusion criteria specific to migraine preventive treatments in

  • 2 phase 3, randomized, double-blind, placebo-controlled, 6-month episodic migraine prevention studies (EVOLVE-1 and EVOLVE-2), and3,4

  • 1 phase 3, randomized, double-blind, placebo-controlled, 3-month chronic migraine prevention study with an optional 9-month open-label extension phase (REGAIN).5

Migraine preventive treatments were not allowed at any time in the episodic migraine studies from the start of the prospective lead-in phase through the end of the double-blind treatment period.3,4

However, in the chronic migraine prevention study, REGAIN, up to one-third of enrolled patients were allowed to continue migraine prophylactic treatment with either topiramate or propranolol if 

  • the patient had been on a stable dose for at least 2 months prior to baseline, and

  • dosing remained stable throughout the double-blind treatment period.5

The percentage of patients who ultimately enrolled in REGAIN under this condition was 15%.5

In each study, patients discontinued botulinum toxin A or B in the head or neck area at least 4 months prior to baseline.3-5 This information is described in Table 2.

Table 2. Phase 3 Protocol Criteria for Discontinuation of Prior Migraine Preventive Treatments3-6

Treatment with

Must be discontinued

Prior to

All prior medications or treatments for the prevention of migraine headachesa

at least 30 days

entering the prospective baseline or baseline period.

Botulinum toxin A and B that has been administered in the head or neck area

at least 4 months

a In REGAIN, up to one-third of enrolled patients were allowed to continue migraine prophylactic treatment with either topiramate or propranolol if the patient had been on a stable dose for at least 2 months prior to baseline, and dosing remained stable throughout the double-blind treatment period.

Therapeutic Indication

Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.7

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.7

References

1. Sacco S, Bendtsen L, Ashina M, et al. European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention [published correction appears in J Headache Pain 2019;20(1):58. http://dx.doi.org/10.1186/s10194-019-0972-5 ]. J Headache Pain. 2019;20(1):6. http://dx.doi.org/10.1186/s10194-018-0955-y

2. American Headache Society. The American Headache Society position statement on integrating new migraine treatments into clinical practice [published correction appears in Headache. 2019;59(4):650-651. http://dx.doi.org/10.1111/head.13506 ]. Headache. 2019;59(1):1-18. http://dx.doi.org/10.1111/head.13456

3. 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

4. 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

5. 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

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

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

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: June 24, 2019

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