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.

Can galcanezumab be used with oral CGRP receptor antagonists for migraine prevention?

The safety and efficacy of concomitant use of galcanezumab with oral CGRP receptor antagonists for migraine prevention have not been established and this combination 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. 

Use With Oral Calcitonin Gene-Related Peptide Receptor Antagonists for Migraine Prevention

The safety and efficacy of galcanezumab used in combination with an oral calcitonin gene-related peptide (CGRP) receptor antagonist for migraine prevention have not been studied. During the galcanezumab phase 3 studies for migraine prevention1-5

  • oral CGRP receptor antagonists were investigational products6,7
  • patients who were enrolled in any other clinical trial involving an investigational product were excluded from participation in galcanezumab clinical trials,8 and
  • patients who participated within the last 30 days or within 5 half-lives, whichever was longer and at least 6 months prior to randomization, in a clinical trial involving an investigational product were excluded from participation in galcanezumab clinical trials.8

Therefore, the safety and efficacy of concomitant use of galcanezumab with oral CGRP receptor antagonists are unknown.

While the use of galcanezumab in patients treated with oral CGRP receptor antagonists is not contraindicated,8 the safety and efficacy of this combination have not been established.

Galcanezumab Mechanism of Action and Indication

Galcanezumab is a humanized immunoglobulin G (subclass) 4 monoclonal antibody that

  • binds CGRP, and
  • prevents its biological activity without blocking the CGRP receptor.8

Galcanezumab is indicated in adults for the

  • prophylaxis of migraine, and
  • prevention of attacks throughout a cluster period in patients with episodic cluster headache.8

Rimegepant Mechanism of Action and Indication

Rimegepant is an oral CGRP receptor antagonist that is approved in adult patients for the

  • acute treatment of migraine with or without aura, and6,7
  • preventive treatment of episodic migraine.9

References

1Stauffer 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

2Skljarevski 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

3Detke 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

4Mulleners WM, Kim BK, Láinez MJA, et al. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2020;19(10):814-825. http://dx.doi.org/10.1016/S1474-4422(20)30279-9

5Camporeale A, Kudrow D, Sides R, et al. A phase 3, long-term, open-label safety study of galcanezumab in patients with migraine. BMC Neurol. 2018;18(1):188. http://dx.doi.org/10.1186/s12883-018-1193-2

6Scott LJ. Rimegepant: first approval. Drugs. 2020;80(7):741-746. http://dx.doi.org/10.1007/s40265-020-01301-3

7Scott LJ. Ubrogepant: first approval. Drugs. 2020;80(3):323-328. http://dx.doi.org/10.1007/s40265-020-01264-5

8Data on file, Eli Lilly and Company and/or one of its subsidiaries.

9Nurtec [package insert]. New Haven, CT: Biohaven; 2021.

Fecha de la última revisión: 2021 M05 28


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