for HD Chorea in Adults

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ABOUT THE CLINICAL STUDY

A clinical study measured the effects of AUSTEDO in people
with Huntington’s disease (HD) chorea1*

FIRST GOAL OF THE STUDY1,2

To measure the effectiveness of AUSTEDO on:

  • HD chorea symptoms using the Total Maximal
    Chorea (TMC) score
  • TMC score progress before, during, and at the
    end of the 12-week study

SECOND GOAL OF THE STUDY1,2

To evaluate the effects of AUSTEDO on:

  • Overall HD symptoms, as reported
    by people and their doctors
  • Limitations on people’s ability to
    perform daily activities

About the study1:

90 people with HD chorea were studied for 12 weeks.

45 people were selected to take AUSTEDO (deutetrabenazine) tablets and 45 people were
selected to take placebo (inactive tablets).

Involuntary movements were measured at the beginning and end of the study, with movements
also being observed at intervals throughout the 12-week period.*

*Once-daily AUSTEDO XR contains the same active ingredient as twice-daily AUSTEDO. Data on this page is based on twice-daily dosing.1

Sex2

Pie chart showing 55.6% male participants and 44.4% female participants in AUSTEDO clinical study.

FEMALE

44.4%

MALE

55.6%

Medications people taking AUSTEDO were able
to continue throughout the trial2

62.2 percent of people taking Austedo® also took antidepressants. 35.5 percent also take antiepileptics. 15.5 percent take antianxiety medications.

ANTIDEPRESSANTS

62.2%

Antiepileptics

35.5%

Antianxiety
medications

15.5%

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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. Frank S, Stamler D, Kayson E, et al. Safety of converting from tetrabenazine to deutetrabenazine for the treatment of chorea. JAMA Neurol. 2017;74(8):977–982. doi:10.1001/jamaneurol.2017.1352