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Emgality Summary of Product Characteristics (SmPC)
Incomplete administration of a galcanezumab maintenance dose has not been studied.
the phase 3 migraine prevention studies,1-3
the galcanezumab injections were administered by investigative site
dosing or partial dosing was not studied during the Lilly clinical
studies. There is no information available regarding the
administration of a second dose in the event where the galcanezumab
maintenance dose was not administered in full.
are encouraged to use their independent clinical judgment to
determine the best course of action for a patient who has
administered a partial galcanezumab maintenance dose.
recommended dose is 120 mg galcanezumab injected subcutaneously once
monthly, with a 240 mg loading dose as the initial dose.5
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.
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.
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.
= Eli Lilly and Company
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.
Date of Last Review:January 13, 2020
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