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Emgality Summary of Product Characteristics (SmPC)
Emgality® ▼ (galcanezumab): Recommended Dosing Frequency in Migraine Prevention
The recommended dose of galcanezumab is 120 mg injected subcutaneously once monthly, with a 240 mg loading dose.
Phase
3 Clinical Trial Dosing
Galcanezumab
was administered monthly in the phase 3 migraine prevention clinical
trials.1-3 In
these studies, dosing visits were scheduled at 30-day intervals, and
subcutaneous injections were allowed to be administered within ±2
days of the scheduled visit.4
Therapeutic
Indication
Galcanezumab
is indicated for the prophylaxis of migraine in adults who have at
least 4 migraine days per month.5
References
1.
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.
http://dx.doi.org/10.1212/WNL.0000000000006640
2.
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.
2018;38(8):1442-1454. http://dx.doi.org/10.1177/0333102418779543
3.
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.
http://dx.doi.org/10.1001/jamaneurol.2018.1212
4.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
5.
Emgality [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
▼ This
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:June 05, 2019
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