Teva Neuroscience, Inc. (“Teva Neuroscience”), maintains this site, www.AUSTEDO.com (the “site”), for your personal information, education, and communication. While you should feel free to browse the site, please understand that your access to and use of the site is subject to the following terms and conditions (“terms and conditions”) and all applicable laws. By accessing and browsing the site, you accept, without limitation or qualification, the terms and conditions and acknowledge that any other agreements between you and Teva Neuroscience concerning the site are superseded to the extent they conflict with these terms and conditions. Your use of or linking to any content of the site, except as provided in these terms and conditions, is strictly prohibited.
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Terms and Conditions
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Office of General Counsel
400 Interpace Parkway
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Effective Date: June 20, 2019
This site is intended only to provide information about AUSTEDO® XR and AUSTEDO® drug therapy. This site was intended specifically for individuals who are U.S. residents. This content has not been approved for non-U.S. residents. The information should not be considered complete and should not be used in place of a visit, call, consultation or advice of your physician or other healthcare provider. This website does not recommend the self-management of health problems. Information obtained through this site is not exhaustive and does not cover all ailments, physical conditions or their treatments. Should you have any healthcare-related questions, please call or see your physician or other healthcare provider promptly. You should never disregard medical advice or delay in seeking it because of something you have read here.
VISITORS TO WWW.AUSTEDO.COM ARE URGED AND ADVISED TO SEEK THE ADVICE OF A PHYSICIAN BEFORE BEGINNING ANY TREATMENT. Such individuals are specifically warned to seek professional medical advice prior to initiating any form of health treatment.
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.