Emgality® (Galcanezumab)

Para consultar la información para prescribir completa de Emgality® (Galcanezumab) de clic en el siguiente enlace: Información para prescribir

La información es proporcionada en respuesta a su solicitud, y puede contener datos relacionados a dosis, usos, formulaciones y poblaciones diferentes a la Información para Prescribir del producto. Consulte la Información para Prescribir en la liga que aparece arriba.

How should a missed or incomplete loading dose of galcanezumab be managed?

In the event of a missed or incomplete loading dose of galcanezumab, complete the loading dose as soon as possible. Then continue with the monthly maintenance dose from the date of last dose.

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Management of Missed or Incomplete Galcanezumab Loading Dose

This medical response may not completely match the information in the current local labeling for GALCANEZUMAB. Please see local labeling for approved label information.

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

In the event of a missed or incomplete loading dose, complete the loading dose as soon as possible. Then continue with the monthly maintenance dose from the date of last dose.

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

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

2Kielbasa 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

3Kielbasa 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

Fecha de la última revisión: 2020 M06 05


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