How AUSTEDO® May Help Treat Huntington's Disease Chorea

for

HD Chorea in Adults

Register

In a 12 week clinical study,

AUSTEDO (deutetrabenazine) tablets significantly reduced Huntington's disease (HD) chorea¹

People taking AUSTEDO saw >2x reduction in HD chorea movements vs placebo*

*4.4-point improvement in people taking AUSTEDO vs 1.9 in people taking placebo based on Total Maximal Chorea (TMC) score. The TMC score is used to measure HD chorea movements in the face, mouth, trunk, both arms, and both legs.

People taking AUSTEDO saw more then 2 times reduction in HD chorea movements vs placebo.

*4.4-point improvement in people taking AUSTEDO vs 1.9 in people taking placebo based on Total Maximal Chorea (TMC) score. The TMC score is used to measure HD chorea movements in the face, mouth, trunk, both arms, and both legs.

An open label study^† showed

symptom relief was sustained for

~3 YEARS^2‡

^†An open label study is a drug trial in which all participants are aware of the drug being tested.
^‡Mean TMC score changed minimally from Week 8 to Week 132 (or end of treatment).

People on AUSTEDO reported improvement in their ability to perform daily activities like^3,4:

Climbing stairs
Moderate to vigorous activities
Lifting/carrying groceries
Bathing
Walking
Dressing
Bending, kneeling, or stooping

People taking AUSTEDO achieved greater improvement in the SF-36^§ Physical Functioning Score at 12 weeks vs placebo⁴

^§SF-36=Short form 36 item survey assessing health-related quality of life.

Both patients and doctors rated overall HD symptoms as "much improved" or "very much improved" at 12 weeks with AUSTEDO.^1,4

51% of people on AUSTEDO saw treatment success vs 20% on placebo^1¶

Very much improved/Much improved

51^%
of people on AUSTEDO saw treatment success^1¶

vs placebo

20^%

42% of doctors saw treatment success vs 13% on placebo^1¶

Very much improved/Much improved

42^%
of doctors saw treatment success^1¶

vs placebo

13^%

^¶Treatment success is measured by perceived improvement in TMC score.

AUSTEDO does not cure the cause of the involuntary movements and it does not treat the other symptoms of HD, such as problems with thinking or emotions.

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

You are about to leave this site

You are about to leave AUSTEDO.com and enter a website operated by a third party. Teva is not responsible for and does not control the content contained on this third-party website linked to AUSTEDO.com.

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.
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 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.

The brands listed are registered trademarks of their respective owners.

References: 1. AUSTEDO^® (deutetrabenazine) tablets current Prescribing Information Parsippany, NJ. Teva Neuroscience, Inc. 2. Frank S, Testa CM, Stamler D, et al; Huntington Study Group ARC-HD Investigators. Long-term efficacy and safety of deutetrabenazine for chorea in Huntington's disease: results from the ARC-HD open-label study. Poster presented at: the 27th Annual Meeting of the Huntington Study Group (HSG); October 29-31, 2020. 3. Burgess JC, Davis B, Fogarty E, et al. Caregiver Guide for Mid to Late Stage Huntington's Disease: For Long-Term Care Facilities and In-Home Care Agencies. Huntington's Disease Society of America; 2014. Accessed January 28, 2022. http://hdsa.org/wp-content/uploads/2015/04/CaregiverGuide_Mid_Late_StageHD.pdf 4. Data on file. Parsippany, NJ: Teva Neuroscience, Inc.