for HD Chorea in Adults

Go about
your day
with
reduced involuntary movements1

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

In a 12-week clinical study,

AUSTEDO significantly
reduced HD chorea1

People taking AUSTEDO saw more than
2x reduction in HD chorea vs placebo.*

With Austedo® there was more than twice the reduction in involuntary body movements at 12 weeks compared with 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.1,2

established safety results

~3 years3†

Mean TMC score changed minimally from Week 8 to Week 132 (or end of treatment).3

This was an open-label study, which is a drug trial in which all participants are aware of the drug being tested.4

51 percent of HD patients on Austedo saw treatment success. 42 percent of doctors saw treatment success.

People reported improvement in HD chorea symptoms1,2

Both doctors and people with HD chorea on AUSTEDO rated symptoms as “very much improved” or “much improved” at 12 weeks with AUSTEDO.

Treatment success is measured by perceived improvement in TMC score.

51 percent of HD patients on Austedo saw treatment success. 42 percent of doctors saw treatment success. 51 percent of HD patients on Austedo saw treatment success. 42 percent of doctors saw treatment success.

People reported improvement in their ability to perform daily activities like2,5:

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

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

See study details

§SF-36=36-Item Short Form Health Survey assessing health-related quality of life.

AUSTEDO XR/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.1

Track your progress

Download the HD Chorea Treatment Tracking Guide to record when
AUSTEDO XR is taken and note any questions for your doctor.

Treatment Tracking Guide

Start the conversation now

Whether you're ready to start medication or planning
ahead, talking to a doctor is the first step.

Check out the discussion guide

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, 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.

4. Open-label. Merriam-Webster. Accessed March 13, 2023. https://www.merriam-webster.com/dictionary/open-label#medicalDictionary

5. 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 February 27, 2023. http://hdsa.org/wp-content/uploads/2015/04/CaregiverGuide_Mid_Late_StageHD.pdf