Emgality® (Galcanezumab)

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Galcanezumab: Recommended Dosing and Administration in Migraine Prevention

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

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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,2-4 dosing visits were scheduled at 30-day intervals.2-6 Subcutaneous injections were allowed to be administered within ±2 days of the scheduled visit.1

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, and
  • without a loading dose, the 120-mg monthly dose did not achieve steady state until 4 to 5 months.7 

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Detke 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

3Skljarevski 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

4Stauffer 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

5Camporeale 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

6Mulleners 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

7Kielbasa 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

Fecha de la última revisión: 2020 M09 28


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