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.

How should a missed or delayed cluster headache dose of EMGALITY® (galcanezumab-gnlm) be managed?

Administer a missed dose as soon as possible.

Management of Missed or Delayed Doses

If a dose is missed during a cluster period, administer as soon as possible.1 Thereafter, galcanezumab can be scheduled monthly from the date of the last dose until the end of the cluster period.

Recommended Dosing for Episodic Cluster Headache

The recommended dose is 300 mg, 3 consecutive injections of 100 mg each, injected subcutaneously at the onset of the cluster period, and then monthly until the end of the cluster period.1

Dose Administration in Phase 3 Episodic Cluster Headache Study

Galcanezumab was studied in a phase 3 randomized, double-blind, placebo-controlled study in adults with episodic cluster headache.2

In the phase 3 episodic cluster headache trial, galcanezumab was dosed 10 to 15 days after the onset of a cluster period, to establish baseline, and then was administered monthly thereafter.2,3 In this study, dosing visits were scheduled at 30-day intervals, and subcutaneous injections were allowed to be administered 2 days before through 5 days after the scheduled visit.3

Pharmacokinetic Considerations

Galcanezumab has a

  • Tmax of 5 days, and

  • t1/2 of 27 days.1,4

A dose of 300 mg monthly would achieve steady-state concentration after the fourth dose.1

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. Goadsby PJ, Dodick DW, Leone M, et al. Trial of galcanezumab in prevention of episodic cluster headache. N Engl J Med. 2019;381(2):132-141. http://dx.doi.org/10.1056/NEJMoa1813440

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

4. Kielbasa W, Helton DL. A new era for migraine: Pharmacokinetic and pharmacodynamic insights into monoclonal antibodies with a focus on galcanezumab, an anti-CGRP antibody. Cephalalgia. 2019;39(10):1284-1297. http://dx.doi.org/10.1177/0333102419840780

Glossary

t1/2 = elimination half-life

Tmax = time of maximum observed drug concentration

Date of Last Review: June 07, 2019

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