Emgality ® (galkanezumab)

För fullständig produktresumé för Emgality® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Emgality® ▼ (galcanezumab): Användning med orala kalcitoningenrelaterad peptidreceptorantagonister

Säkerhet och effekt av samtidig användning av galcanezumab med orala CGRP-receptorantagonister är okänd. Användning av galcanezumab med orala CGRP-antagonister har inte studerats.

Detailed Information

During the galcanezumab phase 3 studies for migraine prevention, oral CGRP receptor antagonists were investigational products.

Patients who were enrolled in any other clinical trial involving an investigational product were excluded from participation in galcanezumab clinical trials.1

The safety and efficacy of concomitant use of galcanezumab with oral CGRP receptor antagonists is unknown.

Galcanezumab for Migraine Prevention

Galcanezumab has been studied in migraine prevention.2-4 

Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.5

Galcanezumab is a humanized IgG4 mAb that

  • binds CGRP, and

  • prevents its biological activity without blocking the CGRP receptor.2-4

References

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

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. 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. 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

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

Glossary

CGRP = calcitonin gene-related peptide

IgG4 = immunoglobulin G (subclass) 4

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.

Datum fӧr senaste ӧversyn 2020 M06 09


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