Sustained Reduction

Long-term extension results consistent with efficacy of pivotal study

Study Design¹
80-week, open-label extension of patients who completed the 12-week pivotal study (N=75)

89% of patients continued into the open-label extension
45 patients (60%) completed 80 weeks

The initial protocol consisted of a total of 24 weeks, with 12 weeks of titration and 12 weeks of maintenance

Patients had the option of enrolling in an extension of the 24-week study to a total of 48 weeks
At 48 weeks, they had the option of enrolling for a total study duration of 80 weeks
There was a 1-week washout period following each study phase
After each 1-week washout period, patients were retitrated to the best individual dose
Chorea was rated using the total maximal chorea score from the UHDRS
3 patients terminated due to adverse events including depression, delusions associated with previous suicidal behavior, and vocal tics

Significant reductions in chorea were sustained through an additional 80 weeks¹

The efficacy of Xenazine was sustained in an open-label, 80-week extension study¹
- 4.6 unit (SD=5.5) reduction at Week 80 compared with baseline
No rebound effect^* with Xenazine discontinuation¹
- After washout, Week 81, chorea re-emerged with a mean increase of 5.3 units (SD=3.2)

^*Rebound effect defined as worsening compared with baseline.

The most common reported adverse events were sedation/somnolence (24%), depressed mood (23%), anxiety (17%), insomnia (13%), and akathisia (12%).¹

Sources:

Frank S. Tetrabenazine as anti-chorea therapy in Huntington disease: an open-label continuation study. Huntington Study Group/TETRA-HD Investigators. BMC Neurol. 2009; 9:62.
Data on file, Lundbeck Inc.

XENAZINE® (tetrabenazine) Tablets

Indications and Usage:

XENAZINE is indicated for the treatment of chorea associated with Huntington’s disease.

Important Safety Information:

WARNING: DEPRESSION AND SUICIDALITY

See full prescribing information for complete boxed warning.

Increases the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease.
Balance risks of depression and suicidality with the clinical need for control of choreiform movements when considering the use of XENAZINE.
Monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior.
Inform patients, caregivers and families of the risk of depression and suicidality and instruct to report behaviors of concern promptly to the treating physician.
Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation.
XENAZINE is contraindicated in patients who are actively suicidal, and in patients with untreated or inadequately treated depression.

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.

Prescribers should periodically re-evaluate the need for XENAZINE in their patients by assessing the beneficial effect on chorea and possible adverse effects including worsening mood, cognition, rigidity and functional capacity. XENAZINE should be titrated slowly over several weeks for a dose that is appropriate for each patient.

Before a dose greater than 50 mg is administered, the patient’s CYP2D6 metabolizer status should be determined. Do not exceed 50 mg/day or 25 mg/dose if XENAZINE is administered with a strong CYP2D6 inhibitor.

Neuroleptic malignant syndrome (NMS), akathisia, agitation, parkinsonism, dysphagia and aspiration pneumonia, and QT prolongation–related arrhythmias have been reported with use of XENAZINE. XENAZINE should not be used in combination with drugs known to prolong QTc (which in certain circumstances can lead to torsades de pointes and/or sudden death), in patients with congenital long QT syndrome, or in patients with a history of cardiac arrhythmias. A potentially irreversible syndrome of involuntary, dyskinetic movements called tardive dyskinesia (TD) may develop in patients treated with neuroleptic drugs. If signs and symptoms of TD appear in a patient treated with XENAZINE, drug discontinuation should be considered. Adverse reactions associated with XENAZINE, such as QTc prolongation, NMS, and extrapyramidal disorders, may be exaggerated by concomitant use of dopamine antagonists.

XENAZINE elevates serum prolactin concentrations. XENAZINE may induce sedation and somnolence (sleepiness or drowsiness) and may impair the ability to drive or operate dangerous machinery. Alcohol or other sedating drugs can worsen sedation and somnolence.

Some adverse events such as depression, fatigue, insomnia, sedation/somnolence, parkinsonism, and akathisia may be dose-dependent. If the adverse effect does not resolve or decrease, consideration should be given to lowering or discontinuing XENAZINE. 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%).

For more information, please see Full Prescribing Information, including Boxed Warning.

®Xenazine is a registered trademark of Biovail Laboratories International (Barbados) S.R.L.

The product information provided in this site is intended only for residents of the U.S. The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider.

Sustained Reduction

Long-term extension results consistent with efficacy of pivotal study

Significant reductions in chorea were sustained through an additional 80 weeks1

WARNING: DEPRESSION AND SUICIDALITY

Significant reductions in chorea were sustained through an additional 80 weeks¹