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): Användning hos barn

Galcanezumabs säkerhet och effektivitet hos patienter under 18 år har inte fastställts.

Detailed Information

The safety and efficacy of galcanezumab in children aged 6 to 18 years have not yet been established. No data are available.1

There is no relevant use of galcanezumab in children below the age of 6 years for the prevention of migraine.1

Clinical Trial Information

Patients in the completed phase 2 and phase 3 galcanezumab clinical trials were required to be between the ages of 18 to 65 years, inclusive, at the time of screening.2

The use of galcanezumab in children ages 6 to 17 years with episodic migraine is currently being studied in a study called REBUILD.3,4

The main purpose of the REBUILD study is to determine the safety and effectiveness of galcanezumab in children diagnosed with migraine, with a history of migraine headaches for at least 6 months.

Therapeutic Indication

Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.1

References

1. Emgality [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

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

3. A study of galcanezumab (LY2951742) in participants 6 to 17 years of age with episodic migraine. Lilly Trial Guide website. https://www.lillytrialguide.com/en-US/studies/migraine/CGAS#?postal. Accessed May 10, 2018.

4. A randomized, double-blind, placebo-controlled study of galcanezumab in patients 6 to 17 years of age with episodic migraine – the REBUILD study. ClinicalTrials.gov website. https://www.clinicaltrials.gov/ct2/show/NCT03432286. Updated March 14, 2018. Accessed May 10, 2018.

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 2017 M11 10


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