AUSTEDO XR should be taken:
Once daily
With water
Whole (do not
crush or break)
With or without food
Once-daily AUSTEDO XR (deutetrabenazine) extended-release tablets has flexible dosing to meet your needs. AUSTEDO XR allows your doctor to adjust your daily dose up or down based on reduction of movements and how well the medicine is tolerated.
Packaging not to scale.
Once daily
With water
Whole (do not
crush or break)
With or without food
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.
Use these tips to help ensure you take AUSTEDO XR as prescribed:
Use the AUSTEDO XR HD Treatment Tracking Guide to help set treatment goals, record when you take AUSTEDO XR, and note any questions you may have for your doctor.
Get the guideFor 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.
Download the HD Chorea Treatment Tracking Guide to record
when AUSTEDO XR is taken and note any questions for your doctor.
AUSTEDO® XR (deutetrabenazine) extended-release tablets and AUSTEDO® (deutetrabenazine) tablets are prescription medicines that are used to treat:
It is not known if AUSTEDO XR and AUSTEDO are safe and effective in children.
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:
Other possible serious side effects include:
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.
References:
1. AUSTEDO® XR (deutetrabenazine) extended-release tablets/AUSTEDO® tablets current Prescribing Information. Parsippany, NJ: Teva Neuroscience, Inc.