Safety [1]
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The safety of Aimovig® has been studied in over 2,500 patients during the registration studies.1. The overall safety profile of Aimovig remained consistent for 5 years of long-term open-label treatment.2,3
In the real-world over 500,000 patients have been treated worldwide with Aimovig®.6
The most common Aimovig® adverse events can be seen in the table below:
*Serious hypersensitivity reactions including rash, angioedema, and anaphylactoid reactions as well as constipation with serious complications were observed during post-marketing experience.
The overall incidence of AEs were comparable to placebo2,3, with clinical trial experience in over 2,500 migraine patients1
*Serious hypersensitivity reactions including rash, angioedema, and anaphylactoid reactions as well as constipation with serious complications were observed during post-marketing experience.
CV = cardiovascular.
‡ In a randomised, double-blind, placebo-controlled study to evaluate the effect of Aimovig® in patients with stable angina, Aimovig® did not decrease exercise duration during a treadmill test compared to placebo.5
In a dedicated cardiovascular study, the effect of a single intravenous dose of 140mg Aimovig® was evaluated in subjects with stable angina under controlled exercise conditions.5 The study results suggests aimovig does not decrease exercise capacity as measured by the change in total exercise time compared to placebo. Aimovig did not adversely affect exercise time in a high cardiovascular risk population of patients, supporting that inhibition of the CGRP receptor does not worsen myocardial ischemia.5
Long-Term Safety of Aimovig®
The safety profile of Aimovig® has been evaluated in a 5-year long-term extension study.4 This is the longest running study of an anti-CGRP treatment. There were no new safety signals and no increases in the incidences of AEs or serious AEs over 5 years of exposure vs the double blind treatment phase.4
For more information about the safety of Aimovig® please refer to the full prescribing information.
References
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Aimovig SmPC available at www.medicines.ie [3] [accessed June 2021]
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Goadsby PJ, et al. N Engl J Med 2017; 377: 2123-2132.
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Tepper S, et al.. Lancet Neurol 2017; 16: 425-434.
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Ashina M, et al. Eur J Neurol. 2021 28(5):1716-1725.
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Depre C, et al. Headache. 2018;58(5):715-723. doi:10.1111/head.13316
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Novartis data on file, February 2021.