Emgality® (Galcanezumab)

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Galcanezumab: Potential Drug-Drug Interactions With Therapeutic Antibodies

Based on the PK characteristics of galcanezumab, drug interactions are not expected. Therefore, no drug interaction studies were conducted. Concomitant use of therapeutic antibodies was not allowed in the phase 3 studies.

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Additional Information Regarding Potential Drug Interactions With Therapeutic Antibodies

Galcanezumab has been studied in migraine prevention and cluster headache.1-5

Patients who are taking, or are expected to take, therapeutic antibodies during the course of the galcanezumab phase 3 studies were excluded from participating.1-5 Examples of therapeutic antibodies included adalimumab, infliximab, trastuzumab, and bevacizumab.6

Prior use of therapeutic antibodies, other than antibodies to CGRP or its receptor, was allowed if

  • that use was more than 12 months prior to the pre-randomization visit in the migraine prevention studies,1-3 or
  • an adequate washout (ie, ≥5 half-lives) has occurred prior to the pre-randomization visit in the cluster headache studies.4,5

Pharmacokinetic Characteristics

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.6,7

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.6-8

Drug Interactions Studies Were Not Conducted

Based on the PK characteristics of galcanezumab, drug interactions are not expected. Therefore, no drug interaction studies were conducted.6

There are no known interactions for galcanezumab, drug-drug or otherwise.6

ReferencEs

1Skljarevski 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

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

3Detke 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

4Goadsby PJ, Dodick DW, Leone M, et al. Trial of galcanezumab in prevention of episodic cluster headache. N Engl J Med. 2019;381(2):132-141. http://dx.doi.org/10.1056/NEJMoa1813440

5Dodick DW, Goadsby PJ, Lucas C, et al. Phase 3 randomized, placebo-controlled study of galcanezumab in patients with chronic cluster headache: results from 3-month double-blind treatment. Cephalalgia. 2020;40(9):935-948. http://dx.doi.org/10.1177/0333102420905321

6Data on file, Eli Lilly and Company and/or one of its subsidiaries.

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

8Lobo 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

CGRP = calcitonin gene-related peptide

IgG = immunoglobulin G

IgG4 = immunoglobulin G (subclass) 4

PK = pharmacokinetics

Fecha de la última revisión: 2020 M01 15


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