Impact of HD Chorea Icon
Impact of HD chorea
Starting AUSTEDO Icon
Starting AUSTEDO
Personalized Support Icon
Personalized support:Shared Solutions®|Getting Started
Resources Icon
Resources
Register Icon
Register

A clinical trial studied the effects of AUSTEDO (deutetrabenazine) tablets in participants with HD chorea1

  • 90 participants with HD chorea were studied for 12 weeks
  • 45 participants were randomly selected to take AUSTEDO and 45 participants were randomly selected to take placebo (inactive tablets)


Primary goal1,2

The trial used the Total Maximal Chorea (TMC) score to measure the effectiveness of AUSTEDO on HD chorea.

  • On this scale, chorea is rated from 0 to 4 (with 0 representing no chorea) across 7 parts of the body. The total score ranges from 0 to 28

Secondary goal1

To evaluate the effects of AUSTEDO on:

  • Overall HD symptoms, as reported by participants and their doctors

Side effects were evaluated throughout the course of the study.

Approved Use

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

Important Safety Information

AUSTEDO can cause serious side effects, 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 the healthcare provider right away if you become depressed or have any of the following symptoms, especially if they are new, worse, or worry you:

  • feel sad or have crying spells
  • lose interest in seeing your friends or doing things you used to enjoy
  • sleep a lot more or a lot less than usual
  • feel unimportant, guilty, hopeless, or helpless
  • feel more irritable, angry, or aggressive than usual
  • feel more or less hungry than usual or notice a big change in your body weight
  • have trouble paying attention
  • feel tired or sleepy all the time
  • have thoughts about hurting yourself or ending your life

Do not take AUSTEDO if you:

  • 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®).

Other possible serious side effects include:

  • Neuroleptic Malignant Syndrome (NMS). 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, 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 or keeping your balance.
  • Irregular heartbeat. 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.

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 include: sleepiness (sedation), diarrhea, tiredness, and dry mouth.

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 Medication Guide in the full Prescribing Information for AUSTEDO.

References: 1. AUSTEDO (deutetrabenazine) tablets Prescribing Information. Teva Pharmaceuticals USA, Inc. April 2017. 2. Huntington disease study group. Unified Huntington’s disease rating scale: reliability and consistency. Mov Disord. 1996;11(2):136-142.
Legal Notice|Privacy Notice|Site Map
AUSTEDO is a trademark of Auspex Pharmaceuticals, Inc., a member of the Teva Group.
Shared Solutions® is a registered service mark of Teva Neuroscience, Inc.
The brands listed are the registered trademarks of their respective owners.
© 2017 Teva Neuroscience, Inc. AUS-40261 May 2017 This site is intended for US residents only.
arrow-up
arrow-down

Approved Use

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

Important Safety Information

AUSTEDO can cause serious side effects, 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 the healthcare provider right away if you become depressed or have any of the following symptoms, especially if they are new, worse, or worry you:

  • feel sad or have crying spells
  • lose interest in seeing your friends or doing things you used to enjoy
  • sleep a lot more or a lot less than usual
  • feel unimportant, guilty, hopeless, or helpless
  • feel more irritable, angry, or aggressive than usual
  • feel more or less hungry than usual or notice a big change in your body weight
  • have trouble paying attention
  • feel tired or sleepy all the time
  • have thoughts about hurting yourself or ending your life

Do not take AUSTEDO if you:

  • 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®).

Other possible serious side effects include:

  • Neuroleptic Malignant Syndrome (NMS). 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, 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 or keeping your balance.
  • Irregular heartbeat. 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.

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 include: sleepiness (sedation), diarrhea, tiredness, and dry mouth.

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 Medication Guide in the full Prescribing Information for AUSTEDO.

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