for Tardive Dyskinesia in Adults

About the clinical studies*

*Once-daily AUSTEDO XR (deutetrabenazine) extended-release tablets contain the same active ingredient as twice-daily AUSTEDO tablets. Data on this page is based on twice-daily dosing.1

AUSTEDO (deutetrabenazine) tablets was studied in a diverse population with the goal of identifying 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.1

A closer look at the data

98%

of people in one study were taking at least one mental health medication, including2,3:

Antidepressants:

  • 54%

    ANTIDEPRESSANTS
    AT BASELINE

Antipsychotics:

  • 62%

    ATYPICAL ANTIPSYCHOTICS

  • 14%

    TYPICAL OR COMBINATION ANTIPSYCHOTICS

  • 24%

    NO ANTIPSYCHOTICS AT BASELINE

Sex1

52 percent of women and 48 percent of men.

48%

48% MALE

52%

52% FEMALE

Underlying mental
health conditions3

50 percent have schizophrenia, 19 percent have depression, 17 percent have bipolar disorder, 10 percent have schizoaffective disorder, and 4 percent have other.

10%

10% SCHIZOAFFECTIVE
DISORDER

17%

17% BIPOLAR DISORDER

19%

19% DEPRESSION

4%

4% OTHER

50%

50% SCHIZOPHRENIA

Throughout both studies, people continued with their mental health medications while taking twice-
daily AUSTEDO to reduce tardive dyskinesia (TD) body movements.1,2

You Don't need to choose between maintaining
your mental health or treating TD1,2

Cherian Karunapuzha, neurologist, sitting in chair.

Watch professionals discuss treating
tardive dyskinesia with AUSTEDO

Patients can continue on their current psychiatric medication regimen along with the addition of AUSTEDO.

Cherian Karunapuzha

Neurologist, Oklahoma City, OK

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Approved Uses

AUSTEDO® XR (deutetrabenazine) extended-release tablets and AUSTEDO® (deutetrabenazine) tablets are prescription medicines that are used to treat:

  • the involuntary movements (chorea) of Huntington’s disease. AUSTEDO XR and AUSTEDO do 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 XR and AUSTEDO are safe and effective in children.

Important Safety Information

AUSTEDO XR and AUSTEDO can cause serious side effects in people with Huntington’s disease, including: depression, suicidal thoughts, or suicidal actions. Do not start taking AUSTEDO XR or 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 XR or 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 XR or AUSTEDO if you:

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

Other possible serious side effects include:

  • Irregular heartbeat (QT prolongation). AUSTEDO XR and 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 XR or AUSTEDO with certain medicines may increase this chance.
  • 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 XR and AUSTEDO. While taking AUSTEDO XR or AUSTEDO, do not drive a car or operate dangerous machinery until you know how AUSTEDO XR or AUSTEDO affects you. Drinking alcohol and taking other drugs that may also cause sleepiness while you are taking AUSTEDO XR or AUSTEDO may increase any sleepiness caused by AUSTEDO XR and 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).

The most common side effects of AUSTEDO XR are expected to be similar to AUSTEDO in people with Huntington’s disease or tardive dyskinesia.

These are not all the possible side effects of AUSTEDO XR or AUSTEDO. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read the accompanying Medication Guide.

 
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References:

1. AUSTEDO® XR (deutetrabenazine) extended-release tablets/AUSTEDO® tablets current Prescribing Information. Parsippany, NJ: Teva Neuroscience, Inc.

2. Data on file. Parsippany, NJ: Teva Neuroscience, Inc.

3. Anderson KE, Stamler D, Davis MD, et al. Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Psychiatry. 2017;4(8):595-604. doi:10.1016/S2215-0366(17)30236-5

4. Abnormal Involuntary Movements Scale (AIMS) – overview. Medical Home Portal. Accessed February 28, 2023. https://www.medicalhomeportal.org/link/6544