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Emgality ® ▼ (galcanezumab)
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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.
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
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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