Emgality® (Galcanezumab)

Para consultar la información para prescribir completa de Emgality® (Galcanezumab) de clic en el siguiente enlace: Información para prescribir

La información es proporcionada en respuesta a su solicitud, y puede contener datos relacionados a dosis, usos, formulaciones y poblaciones diferentes a la Información para Prescribir del producto. Consulte la Información para Prescribir en la liga que aparece arriba.

How should a patient be switched from an oral CGRP receptor antagonist to galcanezumab, or vice versa, for migraine prevention?

Switching from an oral CGRP receptor antagonist to galcanezumab, or vice versa, for migraine prevention has not been systematically studied.

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The information contained in this letter may not completely match the current local labeling for GALCANEZUMAB. Please see local labeling approved in your country.  

Switching to Galcanezumab From an Oral CGRP Receptor Antagonist Has Not Been Studied

The safety and efficacy of switching from an oral calcitonin gene-related peptide (CGRP) receptor antagonist to galcanezumab for migraine prevention have not been systematically studied.

Clinicians are encouraged to use their independent clinical judgment to determine whether an individual patient is a candidate for switching from an oral CGRP receptor antagonist to galcanezumab for migraine prevention. Decisions regarding the optimal time between taking these two medications are best determined based on clinician and patient agreement that take into account the patient’s situation, needs, and preference.

Considerations Regarding Loading Dose When Switching to Galcanezumab

The recommended galcanezumab dose is 120 mg injected subcutaneously once monthly, with a 240-mg loading dose as the initial dose.1

Pharmacokinetic modeling of phase 3 data confirmed that

  • the 240-mg loading dose achieved steady-state galcanezumab concentrations by month 1 for the 120-mg monthly dose regimen, and
  • without a loading dose, the 120-mg monthly dose did not achieve steady state until 4 to 5 months.2

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 Federation3 and the American Headache Society4,5 have issued guidance for practitioners summarized in Management of Other Preventives When Using CGRP mAbs in Patients With Migraine.

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

 

2019 EHF Recommendations3

2019 and 2021 AHS Consensus Statements4,5

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.


Duration of transition from established preventive treatment to anti-CGRP mAb has not been defined. The decision to stop taking established therapy should rely on assessment of onset and magnitude of response with the anti-CGRP mAb at 4, 8, and 12 weeks after treatment with both therapies.

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.

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

Switching From Galcanezumab to an Oral CGRP Receptor Antagonist Has Not Been Studied

The safety and efficacy of switching from galcanezumab to an oral CGRP receptor antagonist for migraine prevention have not been studied.

Clinicians are encouraged to use their independent clinical judgment to determine whether an individual patient is a candidate for switching from galcanezumab to an oral CGRP receptor antagonist for migraine prevention. Decisions regarding the optimal time between taking these two medications are best determined based on clinician and patient agreement that take into account the patient’s situation, needs, and preference.

In healthy subjects and patients with episodic or chronic migraine, galcanezumab has an elimination half-life (t1/2) of 27 days.6

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Kielbasa W, Quinlan T. Population pharmacokinetics of galcanezumab, an anti-CGRP antibody, following subcutaneous dosing to healthy individuals and patients with migraine. J Clin Pharmacol. 2020;60(2):229-239. http://dx.doi.org/10.1002/jcph.1511

3Sacco 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. J Headache Pain. 2019;20(1):58. http://dx.doi.org/10.1186/s10194-019-0972-5

4American Headache Society. The American Headache Society position statement on integrating new migraine treatments into clinical practice. Headache. 2019;59(4):650-651. http://dx.doi.org/10.1111/head.13506

5American Headache Society. The American Headache Society Consensus Statement: update on integrating new migraine treatments into clinical practice. Headache. Published online June 23, 2021. https://doi.org/10.1111/head.14153

6Kielbasa W, Helton DL. A new era for migraine: pharmacokinetic and pharmacodynamic insights into monoclonal antibodies with a focus on galcanezumab, an anti-CGRP antibody. Cephalalgia. 2019;39(10):1284-1297. http://dx.doi.org/10.1177/0333102419840780

Fecha de la última revisión: 2021 M05 28


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