About HD chorea Icon
About HD chorea
Starting AUSTEDO Icon
Starting AUSTEDO®
Personalized Support Icon
Personalized support:Shared Solutions®|Getting started
Resources Icon
Resources
Register Icon
Register

AUSTEDO® (deutetrabenazine) tablets
clinical trial results

AUSTEDO® significantly reduced HD chorea vs placebo1

Change in Total Maximal Chorea (TMC) score

The TMC score was assessed before, during, and at the end of the 12-week trial.

TMC SCORE AT END OF STUDY

  • The TMC score improved by 4.4 points in participants taking AUSTEDO® vs 1.9 points with placebo
  • This represents a 2.5-point improvement in TMC score with AUSTEDO® vs placebo
  • The TMC score improved by at least 6 points for 33% of participants taking AUSTEDO® vs 2% taking placebo

Secondary goal demonstrating the effects of AUSTEDO®

Overall HD symptoms were rated as “much improved” or “very much improved” with AUSTEDO® vs placebo1

51% of participants taking AUSTEDO® reported that their overall HD symptoms were “much improved” or “very much improved” at the end of treatment, compared with 20% of those taking placebo.

42% of doctors treating participants taking AUSTEDO® reported that overall HD symptoms observed were “much improved” or “very much improved” at the end of treatment, compared with 13% treating participants taking placebo.

AUSTEDO® is a medicine to treat HD chorea. It does not treat other symptoms of HD, such as problems with thinking or emotions.



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 in people with Huntington’s disease. Symptoms include: slight shaking, body stiffness, trouble moving, or keeping your balance.

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 Prescribing Information. Teva Pharmaceuticals USA, Inc. August 2017. 2. Medical outcomes study questionnaire short form 36 health survey (SF-36). http://www.brandeis.edu/roybal/docs/SF-36_website_PDF.pdf. Accessed January 26, 2017.
Legal Notice|Privacy Notice|Site Map
The brands listed are the registered trademarks of their respective owners.
© 2017 Teva Neuroscience, Inc. AUS-40469 September 2017 This site is intended for US residents only.
arrow-up
arrow-down

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 in people with Huntington’s disease. Symptoms include: slight shaking, body stiffness, trouble moving, or keeping your balance.

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.

Are you a healthcare professional?

The information on this site is intended for healthcare professionals in the United States. Are you a healthcare professional in the United States?

Yes
Cancel