Information Regarding Potential Drug Interactions With Therapeutic
has been studied in migraine prevention.1-3
who are taking, or are expected to take, therapeutic antibodies
during the course of the galcanezumab phase 3 studies were excluded
of therapeutic antibodies included adalimumab,
infliximab, trastuzumab, and bevacizumab.4
use of therapeutic antibodies, other than antibodies to CGRP or its
receptor, was allowed if
use was more than 12 months prior to the pre-randomization visit in
the migraine prevention studies,1-3
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.5
such, it is not expected to
metabolic or induce enzymatic pathways
metabolized by the cytochrome P450 families of drug-metabolizing
any active metabolites.4,6
Interactions Studies Were Not Conducted
drug interaction studies were conducted. No pharmacokinetic drug
interactions are expected based on the characteristics of
are no known interactions for galcanezumab, drug-drug or otherwise.4
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.
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.
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.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Emgality [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
Lobo ED, Hansen RJ, Balthasar JP. Antibody pharmacokinetics and
pharmacodynamics. J Pharm Sci. 2004;93(11):2645-2668.
= calcitonin gene-related peptide
= immunoglobulin G
= immunoglobulin G (subclass) 4
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.