Xenazine® (tetrabenazine) is contraindicated in patients who are actively suicidal, and in patients with untreated or inadequately treated depression.
In the pivotal study, the most commonly reported adverse events with Xenazine compared to placebo were sedation/somnolence (31% vs 3%), fatigue (22% vs 13%), insomnia (22% vs 0%), depression (19% vs 0%), akathisia (19% vs 0%), anxiety (15% vs 3%), and nausea (13% vs 7%).2
Xenazine is also contraindicated in patients who have impaired hepatic function or are taking monoamine oxidase inhibitors (MAOIs) or reserpine. Xenazine should not be used in combination with an MAOI, or within a minimum of 14 days of discontinuing therapy with an MAOI. At least 20 days should elapse after stopping reserpine before starting Xenazine.
If AEs such as akathisia, restlessness, parkinsonism, agitation, depression, insomnia, fatigue, anxiety or sedation/somnolence occur, titration should be stopped and the dose should be reduced.
If the adverse event does not resolve, consideration should be given to withdrawing Xenazine treatment or initiating other specific treatment (e.g. antidepressants).
Please scroll down for Important Safety Information
In the open-label extension of the pivotal study, the most common reported adverse events were sedation/somnolence (24%), depressed mood (23%), anxiety (17%), insomnia (13%), and akathisia (12%).
XENAZINE® (tetrabenazine) Tablets
Indications and Usage:
XENAZINE is indicated for the treatment of chorea associated with Huntington’s disease.
Important Safety Information:
For more information, please see the full Prescribing Information, including Boxed Warning, the Medication Guide or go to www.XENAZINEusa.com.
Xenazine is a registered trademark of Valeant International Bermuda or its affiliates.
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