Once-daily dosing for tardive dyskinesia (TD)¹

APPROVED USES

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.

Individual results may vary.

Please see the Important Safety Information at the end of this video.

Rebecca Allen: I mostly remember feeling movements in my face, but not until it was brought to my attention…but when somebody had mentioned I was making movements in my face, I did realize it and became very conscious of it.
Rebecca Allen: Hi, my name’s Rebecca, and I’m from Scranton, Pennsylvania.
Dr Jesse: I’m Dr Jane Jesse. I’m a psychiatrist in Pennsylvania. I’ve worked with Rebecca now for the last six years.
Rebecca Allen: When I first met Dr Jesse and Dr Jesse had told me about tardive dyskinesia, I had no knowledge of that condition.
Dr Jesse: When I first met Rebecca, I noticed that she had movements in her face and in her hands. She did complain about the shakiness in her hands. But she also had some jaw-clenching movements within her face. And after that, realizing what medications she’d been on in the past, I realized what we were dealing with was tardive dyskinesia.
Rebecca Allen: I noticed that I was having difficulty doing simple things like preparing food, using a knife, counting change, buttoning, zippering clothing. Those things became more challenging. The movements in my hands, I could not keep my hands still. So I had difficulty, even if I tried consciously.
Dr Jesse: Oftentimes I find myself – I’m the one asking them about their movements first. And they’ll say, “Nobody’s ever asked me about this.” My rule of thumb when I treat patients is that I treat them like I’d want my friends or my family treated. And so I speak with the patients about tardive dyskinesia, and then I offer treatment.
Rebecca Allen: Dr Jesse told me there was a medication that could help me with these involuntary movements I was experiencing and I was willing to try it. And I am very happy that I did because I did see improvement.
Dr Jesse: In the beginning, I was not convinced. I was thinking it was going to be yet another medication…and then I saw the difference. AUSTEDO helped Rebecca in a number of different body areas. I saw a lot of the shakiness in the hands just sort of calm down.
Rebecca Allen: Once I started treatment with AUSTEDO, I did notice that the tasks weren’t as difficult as they were before. I did notice that I felt less movement and I was very happy with the results. Now I’m able to actually function at a higher level. I was able to return to the workforce and I’m feeling as though I’m accomplishing something.
Dr Jesse: I’ve seen improvement in Rebecca’s abnormal movements after she’s been on AUSTEDO.
Rebecca Allen: If you have an uneasy feeling, you should bring it to your doctor’s attention because I’m glad I did and I’ve seen improvement.
Dr Jesse: If a patient is seeing this video and they’re uncertain if they’ve got tardive dyskinesia, they should definitely talk to their healthcare provider about it. If they don’t get enough information or the right answer, then to keep looking for another doctor who takes their story seriously.

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.