In clinical studies, AUSTEDO (deutetrabenazine) tablets reduced tardive dyskinesia symptoms while people continued on their mental health medications.1,2

AUSTEDO: A Treatment for
Tardive Dyskinesia

Hear experts discuss the benefit of treating
tardive dyskinesia with AUSTEDO.

AUSTEDO is a prescription medicine that is used to treat adults with movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).

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.

Individual results may vary.

Please see the Important Safety Information at the end of this video.

…when talking to my patients about AUSTEDO, I tell them that this is a option of medication, or a prescribed medication, that can be given for tardive dyskinesia, that can be used in combination with their antipsychotic medications so that I can treat both their mental health condition, as well as their tardive dyskinesia.

Well, we like to say is that it, because it’s gone through an FDA approval for the specific diagnosis, it means there are multiple trials which are being done to make sure that this drug is efficacious, meaning effective in suppressing the symptoms of tardive dyskinesia. … Of course, in the trials we also saw some patients did not have a great response, or no response to treatment and that happens with all medications. And also there were side effects noted in the trial.

… most common side effects include inflammation of your nose and also disturbances in sleep patterns.

…in the clinical studies, patients had a‐ a three‐point reduction in their AIMS score…

Uh, and you could see benefits as early as two weeks but usually saw them by 12 weeks.

…when you take a look at the results of the clinical trials, they were actually quite nice in really seeing significant differences for individuals in reducing that movement burden.

… knowing that we can initiate someone with this medicine, get them to the right fit for them with again, this flexible approach that then helps us along the lines of being able to counter these movements that they’re having.

…so, the nice thing about AUSTEDO is that we have a large flexibility in dosing. So we can start at six milligrams twice a day and then we can, titrate up from there to efficacy until the patient feels better. we can go from six milligrams to 48 milligrams, we can go anywhere in between depending on what the patients needs are at that time. So, it’s nice and gives us a lot of flexibility in dosing. And we can titrate as needed depending on the patient’s symptoms.

…one of the biggest fears patients have is that their psychiatry regimen, which has been keeping them stable all along will be changed. But what we saw in the trials was that these patients could continue on their current psychiatric medication regimen, along with the addition of AUSTEDO.

The beauty about AUSTEDO is that it allows us an opportunity to keep the background medicines going so that if we’ve got solid control with a mood or a psychotic condition, we don’t have to alter what we’re doing with them and we’re treating the movement problem separately.

APPROVED USES

AUSTEDO is a prescription medicine that is used to treat adults with 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.

For more information about AUSTEDO, please see the Medication Guide available at austedo.com, or by calling 1-800-887-8100.

AUSTEDO reduced the involuntary, repetitive, uncontrolled movements of TD in 2 clinical studies.

Study 1: Involuntary movement reduction at week 121,3

%
TAKING AUSTEDO
vs
%
TAKING PLACEBO
AUSTEDO® (deutetrabenazine) tablets Clinical Study Reduced AIMS* Score Created with Sketch. placebo AUSTEDO ®
  • AUSTEDO reduced the AIMS total score by
    3.3 points vs 1.4 points with placebo from the start of the study.
  • For participants taking AUSTEDO, this represents a 33% reduction in AIMS total score vs a 12% reduction for those taking placebo.
  • Improvement in uncontrolled movements began to be seen at 2 weeks.

A reduction in AIMS total score means reduced involuntary movements.1

understanding aims

Study 2: Involuntary movement reduction at week 121

%
TAKING AUSTEDO
vs
%
TAKING PLACEBO
AUSTEDO® (deutetrabenazine) tablets Clinical Study Created with Sketch. placebo AUSTEDO ®
  • AUSTEDO reduced the AIMS total score by 3.0 points vs 1.6 points with placebo.
  • This represents an approximately 27% reduction in AIMS total score for people taking AUSTEDO vs a 16% reduction for those taking placebo.

Download the Doctor Discussion Guide

Use this guide at your next appointment—whether it’s in person or through telemedicine—to help you and your doctor decide if AUSTEDO is right for you.

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References: 1. AUSTEDO® (deutetrabenazine) tablets current Prescribing Information Parsippany, NJ. Teva Neuroscience, Inc. 2. Data on file. Parsippany, NJ. Teva Neuroscience, Inc. 3. Anderson KE, Stamler D, Davis MD, et al. Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Psychiatry. 2017;4(8):595-604. Published online June 28, 2017. doi: 10.1016/S2215-0366(17)30236-5