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

Vilka potentiella läkemedelsinteraktioner kan förväntas med Emgality® ▼ (galcanezumab)?

Vi förväntar oss inte farmakokinetiska läkemedelsinteraktioner baserade på egenskaperna hos galcanezumab.

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Contraindications and Exclusion Criteria

The concomitant use of galcanezumab and any other medications is not contraindicated, according to the Emgality Summary of Product Characteristics (SmPC).1

Please check the SmPC of all, in combination administered medications.

We excluded patients who are taking, or are expected to take, therapeutic antibodies, for example adalimumab, infliximab, trastuzumab, bevacizumab, during the galcanezumab phase 3 studies from participating.2-5 We do not have data about the safety or efficacy of galcanezumab when concomitantly administered with therapeutic antibodies.

Pharmacokinetic Characteristics of Galcanezumab

As a humanised Immunoglobulin G4 (IgG4) monoclonal antibody, galcanezumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.1

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.5-7

Drug Interaction Studies Were Not Conducted

No drug interaction studies were conducted. No pharmacokinetic drug interactions are expected based on the characteristics of galcanezumab.1

There are no known interactions for galcanezumab, drug-drug or otherwise.5

References

1Emgality [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2Stauffer 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

3Skljarevski 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

4Detke 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

5Data on file, Eli Lilly and Company and/or one of its subsidiaries.

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

7Kielbasa 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

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 2019 M06 10


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