Emgality ® (galkanezumab)

För fullständig produktresumé för Emgality® se FASS.

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Emgality® ▼ (galcanezumab): Metabolism och eliminering

Galcanezumab förväntas metaboliseras via kataboliska vägar på samma sätt som en endogen IgG.

Additional Information Regarding Metabolism and Elimination

As a humanised 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.2,3

Based on a population PK analysis, the apparent clearance of galcanezumab was approximately 0.008 L/hour and the half life of galcanezumab was 27 days.1,4

References

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

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

3. 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

4. Kielbasa 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

Glossary

CL/F = apparent clearance

IgG = immunoglobulin G

IgG4 = immunoglobulin G (subclass) 4

IIV = interindividual variability

PK = pharmacokinetics

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 M07 22


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