Emgality ® (galkanezumab)

För fullständig produktresumé för Emgality® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Emgality® ▼ (galcanezumab): Ofullständig underhållsdos

Ofullständig administrering av en underhållsdos av galcanezumab har inte studerats.

Detailed Information

In the phase 3 migraine prevention studies,1-3 the galcanezumab injections were administered by investigative site personnel.4

Incomplete dosing or partial dosing was not studied during the Lilly clinical studies. There is no information available regarding the administration of a second dose in the event where the galcanezumab maintenance dose was not administered in full.

Clinicians are encouraged to use their independent clinical judgment to determine the best course of action for a patient who has administered a partial galcanezumab maintenance dose. 

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.5

References

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. 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.

Glossary

Lilly = Eli Lilly and Company

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.

Datum fӧr senaste ӧversyn 2020 M01 13


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