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Talk to your doctor about a new treatment that is now available |
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For the treatment of chorea associated
with Huntington's disease (HD)
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Dear [First name],
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The FDA has approved AUSTEDOTM (deutetrabenazine) tablets, a medicine that is used to treat the involuntary movements (chorea) of HD.
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Ask your doctor today if AUSTEDOTM is right for you
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Approved Use
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AUSTEDOTM is a prescription medicine that is used to treat the involuntary movements (chorea) of Huntington's disease. AUSTEDOTM does 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. It is not known if AUSTEDOTM is safe and effective in children.
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Important Safety Information
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AUSTEDOTM can cause serious side effects, including: depression, suicidal thoughts, or suicidal actions.
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Do not start taking AUSTEDOTM 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 AUSTEDOTM is started and when the dose is changed.
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Call the healthcare provider right away if you become depressed or have any of the following symptoms, especially if they are new, worse, or worry you:
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feel sad or have crying spells
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lose interest in seeing your friends or doing things you used to enjoy
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sleep a lot more or a lot less than usual
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feel unimportant, guilty, hopeless, or helpless
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feel more irritable, angry, or aggressive than usual
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feel more or less hungry than usual or notice a big change in your body weight
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have trouble paying attention
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feel tired or sleepy all the time
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have thoughts about hurting yourself or ending your life
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Do not take AUSTEDOTM if you:
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are depressed or have thoughts of suicide.
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have liver problems.
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are taking a monoamine oxidase inhibitor (MAOI) medicine. Do not take an MAOI in 14 days after you stop taking AUSTEDOTM. Do not start AUSTEDOTM if you stopped taking an MAOI in the last 14 days. Ask your healthcare provider or pharmacist if you are not sure.
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are taking reserpine. Do not take medicines that contain reserpine (such as Serpalan® and Renese®-R) with AUSTEDOTM. If your healthcare provider plans to switch you from taking reserpine to AUSTEDOTM, you must wait at least 20 days after your last dose of reserpine before you start taking AUSTEDOTM.
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are taking tetrabenazine (XENAZINE®). If your healthcare provider plans to switch you from tetrabenazine (XENAZINE®) to AUSTEDOTM, take your first dose of AUSTEDOTM on the day after your last dose of tetrabenazine (XENAZINE®).
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Other possible serious side effects include:
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Neuroleptic Malignant Syndrome (NMS). 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, increased sweating.
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Restlessness. You may get a condition where you feel a strong urge to move. This is called akathisia.
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Parkinsonism. Symptoms include: slight shaking, body stiffness, trouble moving or keeping your balance.
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Irregular heartbeat. AUSTEDOTM increases your chance of having certain changes in the electrical activity in your heart. These changes can lead to a dangerous abnormal heartbeat. Taking AUSTEDOTM with certain medicines may increase this chance.
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Sleepiness (sedation) is a common side effect of AUSTEDOTM. While taking AUSTEDOTM, do not drive a car or operate dangerous machinery until you know how AUSTEDOTM affects you. Drinking alcohol and taking other drugs that may also cause sleepiness while you are taking AUSTEDOTM may increase any sleepiness caused by AUSTEDOTM.
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The most common side effects of AUSTEDOTM include: sleepiness (sedation), diarrhea, tiredness, and dry mouth.
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These are not all the possible side effects of AUSTEDOTM. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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Please read the Medication Guide in the full Prescribing Information for AUSTEDO™.
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