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 of Emgality (galcanezumab) for migraine prevention 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

The recommended dose is 120 mg injected subcutaneously once monthly, with a 240-mg loading dose as the initial dose.1 

In the phase 3 migraine-prevention clinical trials, dosing visits were scheduled at 30-day intervals.2-6 Subcutaneous injections were allowed to be administered within ±2 days of the scheduled visit.7

Loading Dose

Pharmacokinetic modeling of phase 3 data confirmed that

  • the 240-mg loading dose achieved steady-state galcanezumab concentrations by month 1 for the 120-mg monthly dose regimen,1 and

  • without a loading dose, the 120-mg monthly dose did not achieve steady state until 4 to 5 months.8   

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

2. Camporeale A, Kudrow D, Sides R, et al. A phase 3, long-term, open-label safety study of galcanezumab in patients with migraine. BMC Neurol. 2018;18(1):188. http://dx.doi.org/10.1186/s12883-018-1193-2

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. Mulleners WM, Kim BK, Láinez MJA, et al. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2020;19(10):814-825. http://dx.doi.org/10.1016/S1474-4422(20)30279-9

5. 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

6. 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

7. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

8. Kielbasa W, Quinlan T. Population pharmacokinetics of galcanezumab, an anti-CGRP antibody, following subcutaneous dosing to healthy individuals and patients with migraine. J Clin Pharmacol. 2020;60(2):229-239. http://dx.doi.org/10.1002/jcph.1511

Date of Last Review: September 28, 2020


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