Austedo (deutetrabenazine)

What is Austedo (deutetrabenazine) and how is it used?

Austedo is a prescription medicine that is used to treat:

• the involuntary movements (chorea) of Huntington’s disease. Austedo 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.
• movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).

What are the most important side effects and other facts about Austedo (deutetrabenazine)?

WARNING

DEPRESSION AND SUICIDALITY IN PATIENTS WITH HUNTINGTON’S DISEASE

Austedo can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyone considering the use of Austedo must balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Patients, their caregivers, and families should be informed of the risk of depression and suicidality and should be instructed to report behaviors of concern promptly to the treating physician.

Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in Huntington’s disease. Austedo is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.

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.

Austedo can cause serious side effects in people with Huntington’s disease, including:

• depression
• suicidal thoughts
• suicidal actions

Do not start taking Austedo if you have Huntington’s disease and 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 or have any of the following symptoms, especially if they are new, worse, or worry you:

• feel sad or have crying spells
• lose interest in seeing your friends or doing things you used to enjoy
• sleep a lot more or a lot less than usual
• feel unimportant
• feel guilty
• feel hopeless or helpless
• feel more irritable, angry, or aggressive than usual
• feel more or less hungry than usual or notice a big change in your body weight
• have trouble paying attention
• feel tired or sleepy all the time
• have thoughts about hurting yourself or ending your life