For the treatment of chorea associated with Huntington’s disease (HD) in adults.
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HD is a neurological, hereditary disease that affects approximately 30,000 Americans.
Chorea is the most visible symptom of HD and can affect the ability to do everyday activities. With chorea, you may experience involuntary, random movements of various parts of your body. AUSTEDO® is a prescription medicine that is used to treat the involuntary movements (chorea) of Huntington’s disease.
AUSTEDO® is a prescription medicine that is used to treat:
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.
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 may report side effects to FDA at 1-800-FDA-1088.
Please read the accompanying Medication Guide.