Drugs Q & A

How Effective is Austedo for Tardive Dyskinesia?

Tardive dyskinesia (TD) is an involuntary neurological movement disorder caused by the use of dopamine receptor blocking drugs that are prescribed to treat certain psychiatric or gastrointestinal conditions.

Long-term use of these drugs may produce biochemical abnormalities in the area of the brain known as the striatum. Neuroleptic drugs are often prescribed for the management of certain mental, neurological, or gastrointestinal disorders. Metoclopramide and prochlorperazine are drugs used for chronic gastrointestinal conditions that may cause tardive dyskinesia. Neuroleptic drugs block dopamine receptors in the brain. Dopamine is a neurotransmitter which is a chemical that helps brain cells to communicate. Although most cases occur after a person has taken these drugs for several years, some cases may occur with shorter use of neuroleptic drugs.

The reasons that some people who take these drugs may get tardive dyskinesia, and some people do not, is unknown. Tardive dystonia is a more severe form of tardive dyskinesia in which slower twisting movements of the neck and trunk muscles are prominent.

Signs & Symptoms

Tardive dyskinesia is characterized by involuntary and abnormal movements of the jaw, lips, and tongue. Typical symptoms include facial grimacing, sticking out the tongue, sucking, or fish-like movements of the mouth. In some cases, the arms and/or legs may also be affected by involuntary rapid, jerking movements (chorea), or slow, writhing movements (athetosis). Symptoms of tardive dystonia include slower, twisting movements of larger muscles of the neck and trunk as well as the face.

What Is Austedo?

Austedo (deutetrabenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor developed by Israel’s Teva Pharmaceuticals. Austedo (deutetrabenazine) works by decreasing the frequency and severity of involuntary, uncontrollable muscle movements that are related to a condition known as Tardive Dyskinesia (TD).

How effective is Austedo (deutetrabenazine) for Tardive Dyskinesia?

Research has shown that Austedo (deutetrabenazine) is an effective medication in the treatment of tardive dyskinesia. One clinical study looked at people with tardive dyskinesia that was caused as a side effect of certain other medications. Some people were given Austedo, at varying doses, while other people were given a placebo (no active drug).

The people’s movements related to tardive dyskinesia were measured using the Abnormal Involuntary Movement Scale (AIMS). This scale measures movements in different areas of the body and also measure the severity of the movements. Higher AIMS scores indicate more abnormal movements than lower scores indicate.

Before treatment was started, AIMS scores were measured in people taking Austedo (deutetrabenazine) at varying doses, and in people taking the placebo. The average AIMS scores in these different groups of people ranged from 9.4 to 10.1.

After 12 weeks of treatment, AIMS scores were evaluated in both groups of people. For people who took Austedo, their AIMS score was lowered by an average of 2.1 to 3.3 points. In comparison, for people who took the placebo, their AIMS score was lowered by an average of 1.4 to 1.6 points.

Important Safety Information

Austedo (deutetrabenazine) can cause serious side effects in people with Huntington’s disease, including depression, suicidal thoughts, or suicidal actions.

Do not start taking Austedo (deutetrabenazine) 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 (deutetrabenazine) 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 (deutetrabenazine) if you:

•        have Huntington’s disease and are depressed or have thoughts of suicide.

•        have liver problems.

•        are taking a monoamine oxidase inhibitor (MAOI) medicine. Do not take an MAOI within 14 days after you stop taking Austedo (deutetrabenazine). Do not start Austedo (deutetrabenazine) if you stopped taking an MAOI in the last 14 days. Ask your healthcare provider or pharmacist if you are not sure.

•        are taking reserpine. Do not take medicines that contain reserpine (such as Serpalan® and Renese®-R) with Austedo (deutetrabenazine). If your healthcare provider plans to switch you from taking reserpine to Austedo (deutetrabenazine), you must wait at least 20 days after your last dose of reserpine before you start taking Austedo (deutetrabenazine).

•        are taking tetrabenazine (Xenazine®). If your healthcare provider plans to switch you from tetrabenazine (Xenazine®) to Austedo (deutetrabenazine), take your first dose of Austedo (deutetrabenazine) on the day after your last dose of tetrabenazine (Xenazine®).

•        are taking valbenazine (Ingrezza®).

Other possible serious side effects include:

•        Irregular heartbeat (QT prolongation). Austedo (deutetrabenazine) 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 (deutetrabenazine) 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 (deutetrabenazine). While taking Austedo (deutetrabenazine), do not drive a car or operate dangerous machinery until you know how Austedo (deutetrabenazine) affects you. Drinking alcohol and taking other drugs that may also cause sleepiness while you are taking Austedo (deutetrabenazine) may increase any sleepiness caused by Austedo (deutetrabenazine).

The most common side effects of Austedo (deutetrabenazine) in people with Huntington’s disease include sleepiness (sedation), diarrhea, tiredness, and dry mouth.

The most common side effects of Austedo (deutetrabenazine) in people with tardive dyskinesia include inflammation of the nose and throat (nasopharyngitis) and problems sleeping (insomnia).

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