AUSTEDO® XR (deutetrabenazine) extended-release tablets and AUSTEDO® (deutetrabenazine) tablets are prescription medicines that are used to treat adults with movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).
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.
Individual results may vary.
Please see the Important Safety Information at the end of this video.
Okay. So about the time that I … actually got diagnosed … with TD … my symptoms included a lot of facial twitches. I had a lot of blinking …. it was like a full facial squint. And … sometimes I would have to hold it for seconds at a time. I twisted my mouth and then I also had… probably fairly often, this rocking thing that I had to do. I had to rock all the time.
…when I first saw my doctor … he zoned in right away on my … facial … twitches. And he asked me if I knew about it. And I said, "Yes." And … he started asking me to do some things to take like some … physical tests …
… he evaluated the movements in my mouth and I know my tongue, and … with my fingers, and…some other things like that. But… it was … really comforting to know that he had a checklist. Like, he spotted this in me, he asked me about it, he took in what I had to say, and then he had a checklist of things … that he just checked off. I mean, that may sound weird, but honestly, that … that was very comforting to me.
…and he said that I have tardive dyskinesia.
I was… unsure what that meant for me and how, ….if it progressed what that was gonna look like. But, you know, I trusted him because first of all, he's the first person that said, "This is something.”
… sometimes when you can put a name on something, and identify it, then it gives you hope that if you know what it is, that's the first step to fixing it. We had several more appointments and, um, he started educating me about exactly what it is, and … how he can treat it… what stuck in my mind was that it's progressive and if you don't treat it, you're not gonna get better.
You know … it was great to know that this was…a disease and that there was treatment. But at the same time, I had to have… a little time to sit with that to decide that was gonna take a chance and try to make it better.
…when my doctor started talking to me about AUSTEDO … It wasn’t just about, ‘Okay here’s a medication that I think can help,’ it was really about ‘I see what’s happening to you and let me walk you through this. Let me hold your hand through this.’ And that was really the turning point for me.
APPROVED USE
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 Medication Guide available at AUSTEDO.com, or by calling 1-800-887-8100.