What to Know About Austedo and Its Approved Uses
What Austedo Is
Austedo is the brand name for deutetrabenazine, an oral prescription medication that affects certain brain chemicals involved in movement control. It belongs to a group of drugs called vesicular monoamine transporter 2 (VMAT2) inhibitors. VMAT2 inhibitors are used to help manage specific involuntary movements that occur in conditions such as Huntington’s disease and tardive dyskinesia.
Deutetrabenazine is chemically related to tetrabenazine but is modified with deuterium atoms, which affect how long the drug stays active in the body. This modification influences dosing schedules and may impact side-effect patterns compared with some older VMAT2 inhibitors.
Austedo is available in immediate-release tablets and in an extended-release form (often labeled as Austedo XR). Both forms contain the same active ingredient but release it differently over time.
How Austedo Works
To understand how Austedo works, it helps to look at VMAT2 and the role of dopamine.
- VMAT2 is a protein that helps package neurotransmitters, including dopamine, into small storage structures (vesicles) within nerve cells.
- Dopamine is one of the main neurotransmitters involved in controlling movement, motivation, and other functions.
- When VMAT2 activity is reduced, less dopamine is stored and released into certain parts of the brain.
Austedo blocks VMAT2, which lowers the amount of dopamine available in nerve cells in movement-related brain regions. In conditions where excessive or unregulated dopamine signaling contributes to involuntary movements, reducing dopamine can help lessen those movements.
Because dopamine is involved in mood, behavior, and other brain functions, altering dopamine levels can also lead to side effects, such as changes in mood or the development or worsening of depression in some individuals.
Approved Uses of Austedo
Regulatory agencies such as the U.S. Food and Drug Administration (FDA) have evaluated Austedo for specific conditions. As of the latest widely available guidance, Austedo is approved for two main uses:
- Treatment of chorea associated with Huntington’s disease in adults
- Treatment of tardive dyskinesia in adults
These approvals are based on clinical trials showing that deutetrabenazine reduced involuntary movements in these conditions compared with placebo.
Use for any condition outside of these approved indications would typically be considered off-label and depends on clinical judgment, local regulations, and evolving research.
Austedo for Huntington’s Disease Chorea
Huntington’s disease is a genetic, progressive brain disorder that affects movement, thinking, and behavior. One of the hallmark movement symptoms is chorea, characterized by sudden, unpredictable, dance-like movements of the face, trunk, and limbs.
Chorea can:
- Interfere with walking and balance
- Make eating, drinking, and speaking difficult
- Increase the risk of falls and injuries
- Affect social interactions and independence
Austedo is approved to help manage chorea in adults with Huntington’s disease. In clinical studies, individuals taking deutetrabenazine generally showed a reduction in chorea severity scores compared with placebo, as measured by standardized rating scales such as the Unified Huntington’s Disease Rating Scale (UHDRS).
Important considerations for Austedo in Huntington’s disease include:
- It addresses chorea symptoms but does not change the underlying progression of Huntington’s disease.
- It may be combined with other medications used for mood, irritability, or other symptoms, although interaction risks must be evaluated.
- Dose adjustments are often gradual, allowing close monitoring of both movement changes and side effects such as sedation or mood changes.
Austedo for Tardive Dyskinesia
Tardive dyskinesia (TD) is a movement disorder characterized by repetitive, involuntary movements, often involving the tongue, lips, face, trunk, or limbs. TD is usually associated with long-term use of certain dopamine receptor–blocking medications, particularly antipsychotic drugs and some anti-nausea medications.
Common features of TD include:
- Lip smacking or puckering
- Tongue protrusion or chewing movements
- Grimacing or facial twitching
- Jerky or writhing movements in the limbs or trunk
Austedo is approved for the treatment of tardive dyskinesia in adults, whether or not the original causative medication is continued. Clinical trials have shown that deutetrabenazine can reduce the severity of abnormal movements in TD based on standardized scales such as the Abnormal Involuntary Movement Scale (AIMS).
Key points for TD treatment with Austedo:
- The decision to start a VMAT2 inhibitor often follows an evaluation of whether the causative antipsychotic or other medication can be reduced, switched, or discontinued.
- Austedo targets movement symptoms and does not address the underlying psychiatric condition that led to antipsychotic use.
- Careful coordination between mental health and neurology or movement-disorder care teams is common when TD is present.
Who May Not Be a Candidate for Austedo
Certain individuals may be advised not to use Austedo or may require extra caution. Labeling and clinical guidance commonly highlight the following contraindications and precautions:
- Active, untreated, or uncontrolled depression or suicidal thoughts
- History of suicide attempts or severe depression, particularly in Huntington’s disease
- Current use of monoamine oxidase inhibitors (MAOIs)
- Use of tetrabenazine or valbenazine in combination with deutetrabenazine
- Liver impairment, especially moderate to severe hepatic impairment, which can change how the drug is processed
- Known allergy or hypersensitivity to deutetrabenazine or its components
These factors require careful assessment. Clinicians often review mental health history, current medications, and liver function tests before considering Austedo.
How Austedo Is Taken
Austedo is typically taken by mouth, with specific dosing that depends on the condition being treated, the formulation used, and the individual’s response and tolerability.
General points often included in prescribing information:
- Doses are usually started low and increased gradually over several weeks.
- Immediate-release tablets are often taken twice daily with food.
- Extended-release tablets are generally taken once daily, often with food, but instructions can vary.
- A maximum daily dose is specified in the prescribing information and should not be exceeded.
- Dose adjustments may be needed for people taking strong CYP2D6 inhibitors (a group of drugs that affect how Austedo is metabolized) or for those known to be poor CYP2D6 metabolizers.
Specific dosing schedules and titration plans are determined by a clinician and can differ between Huntington’s chorea and tardive dyskinesia.
Common Side Effects
As with many medications that affect brain chemistry, Austedo can cause side effects. Not everyone experiences these, and severity can vary. Commonly reported side effects in studies and product labeling include:
- Sleepiness or fatigue
- Diarrhea
- Dry mouth
- Insomnia or changes in sleep pattern
- Depression or low mood
- Anxiety
- Restlessness or agitation
- Weight gain or weight loss in some individuals
Sleepiness and fatigue are often reported, especially during dose increases. This sedating effect may influence activities that require full alertness, such as driving or operating machinery.
Serious Risks and Warnings
Austedo carries several important warnings and precautions. These are often summarized in prescribing information and should be considered carefully:
- Depression and suicidality: Particularly in people with Huntington’s disease, there is a risk of new or worsening depression and suicidal thoughts or behavior. Close monitoring for mood and behavior changes is recommended.
- Neuroleptic malignant syndrome (NMS): A rare but serious condition characterized by fever, muscle rigidity, mental-status changes, and autonomic instability. NMS requires urgent medical evaluation.
- QT prolongation: Austedo may lengthen the QT interval on an electrocardiogram in some individuals, especially at higher doses or in those using other QT‑prolonging drugs. This can increase the risk of certain abnormal heart rhythms.
- Parkinsonism: Symptoms resembling Parkinson’s disease, such as stiffness, slowness of movement, and tremor, can occur due to dopamine depletion.
- Akathisia: A feeling of inner restlessness with an urge to move, sometimes uncomfortable or distressing.
- Worsening of movement disorders: In some individuals, changes in movements may worsen or new movement patterns may appear.
Prompt attention to new or severe symptoms is important so that clinicians can consider dose changes, additional monitoring, or discontinuation.
Drug and Food Interactions
Austedo is metabolized primarily by enzymes in the liver, including CYP2D6. Interactions can occur with substances that affect these enzymes or with drugs that influence heart rhythm or dopamine signaling. Examples often discussed in clinical resources include:
- Strong CYP2D6 inhibitors (such as certain antidepressants and antiarrhythmics), which can raise deutetrabenazine levels and may require dose adjustments.
- Monoamine oxidase inhibitors (MAOIs), which should not be used at the same time as Austedo due to increased risk of serious adverse reactions; a washout period is typically recommended between these medications.
- Drugs that prolong QT interval, where combined use may elevate the risk of abnormal heart rhythms.
- Alcohol or other sedating medications, which may increase drowsiness or impair coordination.
A comprehensive medication review, including over-the-counter products and supplements, is usually important before starting Austedo.
Use in Special Populations
Certain groups require extra consideration:
- Older adults: Age-related changes in drug metabolism and higher likelihood of multiple medications can raise interaction and side-effect risks.
- Liver impairment: Deutetrabenazine exposure can increase substantially in moderate to severe hepatic impairment, and Austedo use is often not recommended in these cases.
- Pregnancy and breastfeeding: Data on Austedo use in pregnancy and lactation remain limited. Decisions typically weigh potential benefits against potential risks to the fetus or nursing infant.
- Children and adolescents: Austedo’s approved uses focus on adults. Use in younger individuals, if considered, would generally be off-label and based on specialist judgment and emerging data, where available.
Monitoring and Ongoing Assessment
Austedo treatment typically involves ongoing monitoring to assess both benefits and risks. This may include:
- Regular evaluation of involuntary movements using standardized scales
- Assessment of mood, behavior, and any suicidal thoughts, especially in Huntington’s disease
- Review of sleep patterns, daytime alertness, and signs of parkinsonism or akathisia
- Periodic review of other medications and potential interactions
- Occasional electrocardiograms (ECGs) in individuals at risk for QT prolongation
Dose adjustments, temporary pauses in therapy, or discontinuation can be considered if side effects become problematic or if benefits do not outweigh risks.
Key Takeaways
Austedo (deutetrabenazine) is a VMAT2 inhibitor approved for two conditions in adults: chorea associated with Huntington’s disease and tardive dyskinesia. By reducing dopamine release in certain brain pathways, it can lessen involuntary movements in many individuals. At the same time, this mechanism can influence mood, behavior, and heart rhythm, leading to important precautions.
Understanding its approved uses, common side effects, serious risks, and interaction potential supports more informed discussions about whether Austedo fits into an overall treatment plan for movement disorders.