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): Immunisering under behandling

Beslutet att administrera vacciner under galcanezumab-behandling måste baseras på den kliniska bedömningen av den ordinerande vårdgivaren.

Additional Information

In the phase 3 migraine prevention clinical studies,

  • patients received vaccines for various indications during double-blind, placebo-controlled and open-label galcanezumab treatment, however

  • subgroup analyses were not completed in this population.1 

Eli Lilly and Company has not evaluated the safety and efficacy of galcanezumab in combination with vaccines.

Based on the mechanism of action and mechanism of elimination of galcanezumab, there is no reason to expect an interaction with the host immune system. 

The decision to administer a vaccination to a patient prior to, during, or after galcanezumab treatment must be based on the clinical judgment of the prescribing healthcare practitioner after careful consideration of the patient's risk factors as well as the risks and benefits of vaccination.

Please follow local guidance regarding vaccine schedules and recommendations. 

CGRP mAbs Have no Direct Specific Immunomodulatory Effect

Calcitonin gene-related peptide mAbs have been engineered to bind to either the CGRP peptide or receptor with high specificity and minimized interaction with the immune system.2-4

Galcanezumab is a humanized IgG4 mAb that

  • binds CGRP, thus

  • preventing its biological activity.5

As such, it is not expected to

  • inhibit metabolic or induce enzymatic pathways

  • be metabolized by the cytochrome P450 families of drug-metabolizing enzymes, and

  • produce any active metabolites.1,6

Vaccines Administered During Phase 3 Migraine Prevention Clinical Trials

Galcanezumab has been studied in phase 3 randomized, double-blind, placebo-controlled studies in adult patients for the prevention of

  • episodic migraine (EVOLVE-1 and EVOLVE-2),7,8 and

  • chronic migraine (REGAIN).9

The studies had a duration of

  • 6 months for prevention of episodic migraine,7,8 and

  • 3 months for prevention of chronic migraine, with an optional 9-month open-label extension phase.9 

Galcanezumab has also been studied in a phase 3, open-label, 12-month safety study for the prevention of episodic or chronic migraine.10

Vaccine usage was low overall in the phase 3 migraine prevention studies.1 The influenza vaccine was the most commonly administered vaccine during galcanezumab treatment, with reported usage in 1.26% to 2.82% of patients receiving galcanezumab.

Other vaccines administered to at least one galcanezumab-treated patient included

  • anthrax 

  • hepatitis 

  • human papilloma 

  • meningococcal 

  • pneumococcal

  • tetanus, and

  • varicella zoster.1

Subgroup analyses were not completed in this population. 

References

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

2. Raffaelli B, Reuter U. The biology of monoclonal antibodies: focus on calcitonin gene-related peptide for prophylactic migraine therapy. Neurotherapeutics. 2018;15(2):324-335. http://dx.doi.org/10.1007/s13311-018-0622-7

3. Silberstein S, Lenz R, Xu C. Therapeutic monoclonal antibodies: what headache specialists need to know. Headache. 2015;55(8):1171-1182. http://dx.doi.org/10.1111/head.12642

4. Levin M, Silberstein SD, Gilbert R, et al. Basic considerations for the use of monoclonal antibodies in migraine. Headache. 2018;58(10):1689-1696. http://dx.doi.org/10.1111/head.13439

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

6. Lobo ED, Hansen RJ, Balthasar JP. Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci. 2004;93(11):2645-2668. https://doi.org/10.1002/jps.20178

7. 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

8. 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

9. 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

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

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 2018 M06 29


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