Administration in Phase 3 Migraine Prevention Studies
has been studied in phase 3 randomized, double-blind,
placebo-controlled studies in adult patients for the prevention of
migraine (EVOLVE-1 and EVOLVE-2),1,2
were randomized at the beginning of double-blind treatment in a 2:1:1
ratio to receive monthly subcutaneous injections of
120 mg with a loading dose of 240 mg, or
these studies, the 240 mg galcanezumab dose was not observed to be
more efficacious overall than the 120 mg dose.4
Therefore, the recommended dose is 120 mg injected
subcutaneously once monthly, with a 240 mg loading dose as the
note that a maintenance dose of 240 mg galcanezumab once monthly is
not approved and therefore not recommended.
galcanezumab Cmax, ss
at monthly doses of 120 mg is achieved after the 240 mg loading
modeling of phase 3 data confirmed that the 240 mg loading dose
achieved steady-state galcanezumab concentrations by month 1 for the
120 mg/month dose regimen.4
is indicated for the prophylaxis of migraine in adults who have at
least 4 migraine days per month.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.
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.
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.