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

Hur ska en missad eller ofullständig laddningsdos av Emgality® ▼ (galcanezumab) hanteras?

I händelse av en missad eller ofullständig laddningsdos av galcanezumab, injicera laddningsdosen så snart som möjligt. Fortsätt sedan med den månatliga underhållsdosen från datumet för den senaste dosen.

Management of Missed or Incomplete Galcanezumab Loading Dose

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

Patients should be instructed to inject a missed dose as soon as possible and then resume monthly dosing.1

Pharmacokinetic Considerations

In healthy subjects and patients with episodic or chronic migraine, galcanezumab has a

  • Tmax of 5 days, and

  • t1/2 of 27 days.1,2

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.3 

References

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

2. 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

3. 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

Glossary

t1/2 = elimination half-life

Tmax = time of maximum observed drug concentration

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 M06 05


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