Emgality ® (galcanezumab-gnlm) injection

100 mg/mL, 120 mg/mL

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.

EMGALITY® (galcanezumab-gnlm): Recommended Dosing and Administration in Migraine Prevention

The recommended dose is 120 mg injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.

Dose Administration in Phase 3 Migraine Prevention Studies

Galcanezumab has been studied in phase 3 randomized, double-blind, placebo-controlled studies in adult patients for the prevention of

  • episodic migraine (EVOLVE-1 and EVOLVE-2),1,2 and

  • chronic migraine (REGAIN).3

Patients were randomized at the beginning of double-blind treatment in a 2:1:1 ratio to receive monthly subcutaneous injections of 

  • placebo

  • galcanezumab 120 mg with a loading dose of 240 mg, or

  • galcanezumab 240 mg.1-3 

In these studies, the 240 mg galcanezumab dose showed no additional benefit over the 120 mg dose. Therefore, the recommended dosage of galcanezumab is 240 mg (2 consecutive subcutaneous injections of 120 mg each) once as a loading dose, followed by monthly doses of 120 mg injected subcutaneously.4

Loading Dose

A loading dose of 240 mg achieved the serum steady-state galcanezumab concentration after the first dose for the 120 mg/month dose regimen.4

Enclosed Prescribing Information

EMGALITY® (galcanezumab-gnlm) injection, for subcutaneous use, Lilly

References

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).

1. 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

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. 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

4. Emgality [package insert]. Indianapolis, IN: Eli Lilly and Company; 2019.

Date of Last Review: January 16, 2018

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