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for Tardive Dyskinesia in Adults

Once-daily dosing for tardive dyskinesia (td) to keep your day going1

Once-daily AUSTEDO XR (deutetrabenazine) extended-release tablets is a titrated medication, which means your doctor will adjust your dose up or down until you find the dose that provides effective movement reduction while ensuring the medicine is tolerated.

Talk to your doctor about
taking AUSTEDO XR for
once-daily dosing.

See how Teva Shared Solutions® can help
make treatment affordable
Austedo® XR 4-week titration kit package.

Start AUSTEDO XR at no cost with
the 4-Week Titration Kit

Available as a sample or with a prescription from your doctor

Sample Titration Kit

Given to you at your doctor’s office

or

Prescription Titration Kit

Prescription given to you to be filled at your pharmacy. Participating pharmacies will apply a 30-day Free Trial Voucher* to your prescription so it is no cost to you.

*The 30-Day Free Trial Voucher is only for new patients. Voucher is good for up to 4 weeks of titration or 30 days of medication.

Packaging not to scale.

Getting started with AUSTEDO XR1:

This is the dosing schedule for the Titration Kit. Upon completion of the kit, your doctor will write you a prescription for AUSTEDO XR and determine what daily dose is right for you.

Titration Schedule

Once-Daily Dosing (mg)

Dosing Totals

Week 1

12 mg

Week 2

+

18 mg

Week 3

24 mg

Week 4

+

30 mg

Titration
Schedule

Once-daily
Dosing (mg)

Dosing
Totals

Week 1

12 mg

Week 2

+

18 mg

Week 3

24 mg

Week 4

+

30 mg

AUSTEDO XR is available in 6 mg, 12 mg, and 24 mg extended-release tablets and can be combined up to a daily maximum strength of 48 mg. In one clinical study, the average dose of AUSTEDO® (deutetrabenazine) tablets after treatment was ~38 mg daily.*

*Once-daily AUSTEDO XR contains the same active ingredient as twice-daily AUSTEDO. Data on this page is based on twice-daily dosing.1 Pills are for illustration only and not actual size or likeness.

Reaching your maintenance dose1

Once you reach a dose that provides effective movement reduction and is tolerated, that will become your maintenance dose—the dose you stay on moving forward.

It’s important to take AUSTEDO XR exactly as prescribed by your doctor. If you experience a change in symptoms, share these details with your doctor as they may decide to adjust your dose.

 

Take AUSTEDO XR/
AUSTEDO as prescribed by your doctor1

AUSTEDO XR should be taken:

Once daily

With water

Whole (do not
crush or break)

With or without food

AUSTEDO should be taken:

Twice daily

With water

Whole (do not
crush or break)

With food

If you cannot swallow AUSTEDO XR/AUSTEDO tablets whole, tell your healthcare provider. You may need a different medication.

We increased until we got to the right
dose. Once we got the correct dosage, I
did notice improvement.

Rebecca, living with TD

Individual results may vary.

Rebecca and Dr. Jesse sitting down in chairs.

See how Rebecca and her doctor, Dr Jesse,
worked together in treating Rebecca's TD

Treatment tips

Use these tips to help ensure you take AUSTEDO XR as prescribed:

For additional information about how to take AUSTEDO XR, please read the Medication Guide. Ask your doctor if you have any questions about taking AUSTEDO XR.

Track your progress

Download the TD treatment tracking guide to record when
AUSTEDO XR is taken and note any questions for your doctor.

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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Reference:

1. AUSTEDO® XR (deutetrabenazine) extended-release tablets/AUSTEDO® tablets current Prescribing Information. Parsippany, NJ: Teva Neuroscience, Inc.