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Emgality ® ▼ (galcanezumab)
This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information:
Emgality Summary of Product Characteristics (SmPC)
How should a missed or incomplete loading dose of Emgality® ▼ (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.
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
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.
Date of Last Review:June 05, 2020
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