image of person with labels on the  face, torso, hands, and feet indicating involuntary movements in these areas.

In clinical studies, AUSTEDO® reduced TD symptoms while people continued on their mental health medications.1-3

AUSTEDO® reduced the involuntary, repetitive movements of TD in 2 clinical studies

Understanding the AIMS score used in the studies1,4

The primary goal of both studies was to identify the change in involuntary movements — as measured by the Abnormal Involuntary Movement Scale (AIMS) total score — from the beginning to the end of the 12-week studies.

AIMS uses a checklist to assess the severity of involuntary movements and can also be used to track changes in the movements over time.

AIMS rates movements over multiple areas of the body, including the face, torso, arms, and legs. The severity of involuntary movements in each area is scored from 0–4, with 0 = no movements and 4 = severe movements.

A reduction in AIMS total score means reduced involuntary movements.

Study 1: Involuntary movement reduction at week 121

%
TAKING AUSTEDO®
vs
%
TAKING PLACEBO
AUSTEDO® (deutetrabenazine) tablets Clinical Study Reduced AIMS* Score Created with Sketch. placebo AUSTEDO ®

Study 1: Involuntary movement reduction at week 121

  • AUSTEDO® reduced the AIMS total score by
    3.3 points vs 1.4 points with placebo from the start of the study
    • For participants taking AUSTEDO®, this represents a 33% reduction in AIMS total score vs a 12% reduction for those taking placebo
  • Improvement in uncontrolled movements began to be seen at 2 weeks.
Alternate Text

Study 2: Involuntary movement reduction at week 121

%
TAKING AUSTEDO®
vs
%
TAKING PLACEBO
AUSTEDO® (deutetrabenazine) tablets Clinical Study Created with Sketch. placebo AUSTEDO ®

Study 2: Involuntary movement reduction at week 121

  • AUSTEDO® reduced the AIMS total score by
    3.0 points vs 1.6 points with placebo from the start of the study
    • For participants taking AUSTEDO®, this represents an approximately 27% reduction in AIMS total score vs a 16% reduction for those taking placebo

Download the Doctor Discussion Guide

This resource can help you and your doctor decide if AUSTEDO® is right for you.

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Approved Uses

AUSTEDO® is a prescription medicine that is used to treat:

  • the involuntary movements (chorea) of Huntington’s disease. AUSTEDO® does not cure the cause of the involuntary movements, and it does not treat other symptoms of Huntington’s disease, such as problems with thinking or emotions.
  • movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).

It is not known if AUSTEDO® is safe and effective in children.

Important Safety Information

AUSTEDO® can cause serious side effects in people with Huntington’s disease, including: depression, suicidal thoughts, or suicidal actions. Do not start taking AUSTEDO® if you are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts or feelings. This is especially important when AUSTEDO® is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of suicide.

Do not take AUSTEDO® if you:

  • have Huntington’s disease and are depressed or have thoughts of suicide.
  • have liver problems.
  • are taking a monoamine oxidase inhibitor (MAOI) medicine. Do not take an MAOI within 14 days after you stop taking AUSTEDO®. Do not start AUSTEDO® if you stopped taking an MAOI in the last 14 days. Ask your healthcare provider or pharmacist if you are not sure.
  • are taking reserpine. Do not take medicines that contain reserpine (such as Serpalan® and Renese®-R) with AUSTEDO®. If your healthcare provider plans to switch you from taking reserpine to AUSTEDO®, you must wait at least 20 days after your last dose of reserpine before you start taking AUSTEDO®.
  • are taking tetrabenazine (Xenazine®). If your healthcare provider plans to switch you from tetrabenazine (Xenazine®) to AUSTEDO®, take your first dose of AUSTEDO® on the day after your last dose of tetrabenazine (Xenazine®).
  • are taking valbenazine (Ingrezza®).

Other possible serious side effects include:

  • Irregular heartbeat (QT prolongation). AUSTEDO® increases your chance of having certain changes in the electrical activity in your heart. These changes can lead to a dangerous abnormal heartbeat. Taking AUSTEDO® with certain medicines may increase this chance. If you are at risk of QT prolongation, your healthcare provider should check your heart before and after increasing your AUSTEDO® dose above 24 mg a day.
  • Neuroleptic Malignant Syndrome. Call your healthcare provider right away and go to the nearest emergency room if you develop these signs and symptoms that do not have another obvious cause: high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, or increased sweating.
  • Restlessness. You may get a condition where you feel a strong urge to move. This is called akathisia.
  • Parkinsonism. Symptoms include: slight shaking, body stiffness, trouble moving, trouble keeping your balance, or falls.

Sleepiness (sedation) is a common side effect of AUSTEDO®. While taking AUSTEDO®, do not drive a car or operate dangerous machinery until you know how AUSTEDO® affects you. Drinking alcohol and taking other drugs that may also cause sleepiness while you are taking AUSTEDO® may increase any sleepiness caused by AUSTEDO®.

The most common side effects of AUSTEDO® in people with Huntington’s disease include sleepiness (sedation), diarrhea, tiredness, and dry mouth.

The most common side effects of AUSTEDO® in people with tardive dyskinesia include inflammation of the nose and throat (nasopharyngitis) and problems sleeping (insomnia).

These are not all the possible side effects of AUSTEDO®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please read the accompanying Medication Guide.

References: 1. AUSTEDO® (deutetrabenazine) tablets current Prescribing Information. Teva Pharmaceuticals USA, Inc. 2. Data on file. Teva Neuroscience, Inc. 3. Warikoo N, Schwartz TL, Citrome L. Tardive dyskinesia. In: Aguilar, M, ed. Antipsychotic Drugs: Classification, Pharmacology and Long-Term Health Effects. Hauppauge, NY: Nova Science Publishers, Inc; 2013:235-258. 4. Abnormal Involuntary Movement Scale (AIMS) – overview. Center for Quality Assessment and Improvement in Mental Health website. http://www.cqaimh.org/pdf/tool_aims.pdf. Accessed June 10, 2019.