Emgality® (Galcanezumab)

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Galcanezumab: Metabolism and Elimination

Galcanezumab is expected to be degraded via catabolic pathways in the same manner as an endogenous IgG.

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Additional Information Regarding Metabolism and Elimination

This medical response may not completely match the information in the current local labeling for GALCANEZUMAB. Please see local labeling for approved label information.

Galcanezumab is an IgG4 monoclonal antibody and is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.1,2

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.1,3

Based on a population PK analysis, the CL/F was approximately 0.008 L/h with 34% IIV, and was similar in healthy subjects and patients with chronic or episodic migraine.1,2

References

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

2Kielbasa 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

3Lobo ED, Hansen RJ, Balthasar JP. Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci. 2004;93(11):2645-2668. https://doi.org/10.1002/jps.20178

Glossary

CL/F = apparent clearance

IgG = immunoglobulin G

IgG4 = immunoglobulin G (subclass) 4

IIV = interindividual variability

PK = pharmacokinetics

Fecha de la última revisión: 2020 M07 22


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