Pronunciation: aw-STED-oh
Generic name: deutetrabenazine [ doo-TET-ra-BEN-a-zeen ]
Brand names: Austedo, Austedo XR
Dosage form: Austedo tablets (6 mg, 12 mg, 24 mg), Austedo XR tablets (6 mg, 9 mg, 12 mg, 30 mg, 36 mg, 42 mg, and 48 mg)
Drug class: VMAT2 inhibitors

Medically reviewed by Melisa Puckey, BPharm. Last updated on Aug 23, 2024.

What is Austedo?

Austedo and Austedo XR (deutetrabenazine) are used to treat chorea (sudden involuntary movements) caused by Huntington's disease (an inherited disease that causes the progressive breakdown of nerve cells in the brain). Deutetrabenazine is not a cure for Huntington's disease and will not treat other symptoms of this condition.

Austedo is also used in adults to treat symptoms of tardive dyskinesia (TD), a nervous system disorder. Tardive dyskinesia causes repetitive uncontrolled muscle movements, usually in the face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement).

Austedo belongs to a class of medications called vesicular monoamine transporter 2 (VMAT2) inhibitors. It works by changing the activity of certain natural substances in the brain that affect nerves and muscles.

Austedo is taken twice daily, and Austedo XR (extended-release tablet) is taken once daily.

How does Austedo work?

Body movement or motor function is controlled in the brain by nerve cells (neurons) that speak to each other by passing chemical messengers (neurotransmitters) from one nerve cell to another nerve cell.

In movement disorders such as Huntington’s disease and tardive dyskinesia there can be a problem with this system and by lowering the amount of chemical messengers between the nerve cells you relieve the uncontrolled movements.

A protein called VMAT2 controls how much chemical messenger is stored in the nerve cell and how much is released. The VMAT2 inhibitors block VMAT2 which means there is a lower amount of neurotransmitter available and therefore reduces the unwanted body movements.

What is the cost of Austedo?

The cost of prescription drugs varies depending on your insurance plan and which pharmacy you use. Refer to our price guide page for more information about the cost of Austedo.

You may also be eligible for a Austedo savings card or Austedo coupon. Ask your doctor or pharmacist if you qualify.

Warnings

QTc Prolongation

This medicine may prolong the QT interval, but the degree of QT prolongation is not clinically significant when administered within the recommended dosage range. Austedo XR and Austedo should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias associated with a prolonged QT interval.

Certain circumstances may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including:

• slow heart rate (bradycardia),
• low potassium levels (hypokalemia),
• low magnesium blood levels (hypomagnesemia),
• having a congenital prolongation of the QT interval, and
• concomitant use of other drugs that prolong the QTc interval.

Depression and Suicide

Some people have thoughts about suicide while taking Austedo tablets and extended release tablets; stay alert to changes in your mood, feelings, thoughts, or behaviors. Tell your doctor right away if you have any sudden changes in mood or behavior or thoughts about suicide.

You should not use Austedo tablets or extended-release tablets if you have Huntington’s disease and you have untreated or uncontrolled depression or if you have thoughts about suicide.

Other medicines

Do not use this medicine if you have taken reserpine (Serpalan, Renese-R) in the past 20 days, or if you have used an MAO inhibitor (isocarboxazid, linezolid, rasagiline, selegiline, and others) in the past 14 days. See Interactions section for more interactions with this medicine.

Before taking this medicine

You should not use Austedo if you are allergic to deutetrabenazine, or if you have:

• untreated or uncontrolled depression;

• thoughts about suicide or hurting yourself;

• if you have recently taken tetrabenazine or valbenazine; or

• liver disease.

Do not use Austedo if you have taken reserpine in the past 20 days, or if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.

To make sure Austedo is safe for you, tell your doctor if you have ever had:

• depression, anxiety, nervousness, or agitation;

• mental illness or psychosis;

• suicidal thoughts or actions;

• breast cancer;

• a heart rhythm disorder;

• long QT syndrome (in you or a family member);

• an electrolyte imbalance (such as low blood levels of potassium or magnesium); or

• liver disease.

People with Huntington's disease may have a higher risk of depression and suicidal thoughts or behaviors. Taking Austedo may further increase this risk. However, the benefits of taking this medicine (improvement in daily living) may outweigh any suicidal risks.

Taking Austedo may cause symptoms similar to Parkinson's disease (resting tremor, stiff muscles, slow movements, difficulty maintaining balance and walking). Ask your doctor about your risk.

Your doctor will need to check your progress on a regular basis. Your family or caregivers should also watch for sudden changes in your behavior.

Tell your doctor if you are pregnant or breastfeeding.

How should I take Austedo?

Take Austedo as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

If you are switching from a similar medicine called tetrabenazine, take your first dose of Austedo one day after your last dose of tetrabenazine.

Austedo tablets are taken twice daily with food. Swallow whole. Do not chew, crush, or break tablets. Take Austedo's total daily dosage of 12 mg or above in two divided doses.

Austedo XR tablets are taken once daily with or without food. Swallow whole. Do not chew, crush, or break tablets.

You may need medical tests to check your heart function using an electrocardiograph or ECG (sometimes called an EKG).

Do not stop the medicine without your doctor's advice. If you stop taking Austedo for longer than 1 week, do not start taking it again without your doctor's advice.

Store at room temperature away from moisture and heat. Keep the medicine in the original container, along with the packet or canister of moisture-absorbing preservative.

Dosing information

Austedo dosing information

Initial Dose: 6 mg twice daily (12 mg per day).
Dose titration: May increase dose in increments of 6 mg/day at weekly intervals, based on reduction of chorea or tardive dyskinesia, and tolerability up to a maximum of 48 mg/day in divided doses.
Maximum Dose: 48 mg/day in divided doses.
Important Administration Instructions:

• Take Austedo with food
• Swallow whole. Do not chew, crush, or break tablets
• Take Austedo total daily dosages of 12 mg or above in two divided doses.

Austedo XR dosing information

Initial Dose: 12 mg once daily (12 mg per day).
Dose titration: May increase dose in increments of 6 mg/day at weekly intervals, based on reduction of chorea or tardive dyskinesia, and tolerability up to a maximum of 48 mg/day.
Maximum Dose: 48 mg/day
Important Administration Instructions:

• Take XR tablets with or without food
• Swallow whole. Do not chew, crush, or break tablets.
• Take Austedo XR once daily.

Switching Between Austedo and Austedo XR

When switching between Austedo tablets (twice daily) and Austedo XR extended-release tablets (once daily), switch to the same total daily dosage.

Dose modifications

Dose modification is required for Strong CYP2D6 Inhibitors and in Poor CYP2D6 Metabolizers.

Discontinuation and Interruption of Treatment

Treatment with this medicine can be discontinued without tapering. Following treatment interruption of greater than one week, this therapy should be re-titrated when resumed. For treatment interruption of less than one week, treatment can be resumed at the previous maintenance dose without titration.

Austedo is avialable as:

• Austedo tablets are available as 6 mg, 9 mg, and 12 mg.
• Austedo XR (extended-release tablet) is available as 6 mg, 12 mg, 18 mg, 24 mg, 30 mg, 36 mg, 42 mg, and 48 mg.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include involuntary muscle movements, tremors, rapid eye movements, nausea, vomiting, diarrhea, flushing, sweating, severe drowsiness, confusion, hallucinations, or feeling light-headed.

What should I avoid while taking Austedo?

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Drinking alcohol with this medicine can cause side effects.

Austedo side effects

Get emergency medical help if you have signs of an allergic reaction to Austedo: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people have thoughts about suicide while taking Austedo. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Some side effects may actually be signs that your Huntington's disease is progressing. Your doctor will need to check your progress on a regular basis.

Deutetrabenazine may cause serious side effects. Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• severe restlessness or agitation;

• tremors, shaking;

• muscle stiffness;

• problems with balance or coordination; or

• severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common Austedo side effects may include:

• drowsiness;

• tiredness;

• dry mouth;

• runny or stuffy nose, sore throat;

• sleep problems (insomnia); or

• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Austedo and Austedo XR?

QT Prolongation This medicine may prolong the QT interval and should not be used with medicines that prolong the QTc interval. Talk to your healthcare provider about other medicines you take, or if you start taking new medicines.

Reserpine. Do not take Austedo or Austedo XR if you are taking reserpine. If your healthcare provider plans to switch you from taking reserpine to this medicine you must wait at least 20 days after your last dose of reserpine before you start taking Austedo or Austedo XR.

Monoamine oxidase inhibitor (MAOI) medicine. Do not take an MAOI within 14 days after you stop taking Austedo or Austedo XR. Do not start this medicine if you stopped taking an MAOI (isocarboxazid, linezolid, rasagiline, selegiline, and others) in the last 14 days. Ask your healthcare provider or pharmacist if you are not sure.

Tetrabenazine. Austedo or Austedo XR is contraindicated in patients currently taking tetrabenazine. If your healthcare provider plans to switch you from tetrabenazine to Austedo or Austedo XR take your first dose of Austedo or Austedo XR on the day after your last dose of tetrabenazine.

Valbenazine. Austedo or Austedo XR is contraindicated in patients currently taking valbenazine.

Neuroleptic Drugs The risk of parkinsonism, Neuroleptic Malignant Syndrome (NMS), and being unable to remain still (akathisia) may be increased by using this medicine with dopamine antagonists or antipsychotics. Talk to your healthcare provider about other medicines you take, or if you start taking new medicines.

Alcohol or Other Sedating Drugs Using alcohol or other sedating drugs may have additive effects and make sedation and sleepiness worse.

Strong CYP2D6 inhibitors. A dose reduction in Austedo or Austedo XR may be necessary when adding a strong CYP2D6 inhibitor in patients maintained on a stable dose of Austedo or Austedo XR. Using strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine, bupropion) has been shown to increase Austedo or Austedo XR effectiveness. If you are using strong CYP2D6 inhibitors the maximum recommended dose of Austedo or Austedo XR is 36 mg per day.

This list is not complete, and many other drugs can interact with Austedo or Austedo XR. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
Click the link below to check for interactions with this medicine.

Storage

• Store tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep the bottle tightly closed to protect tablets from light and moisture.
• Do not throw away the desiccant canister in the bottle until the last dose has been taken.

Ingredients

Active ingredient: deutetrabenazine.
Inactive ingredients AUSTEDO: ammonium hydroxide, black iron oxide, n-butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, polysorbate 80, polyvinyl alcohol, povidone, propylene glycol, shellac, talc, titanium dioxide, and FD&C blue #2 lake. The 6 mg tablets also contain FD&C red #40 lake. The 12 mg tablets also contain FD&C yellow #6 lake.

Inactive ingredients AUSTEDO XR: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, cellulose acetate, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, magnesium stearate, polyethylene glycol, polyethylene glycol 3350, polyethylene oxide, polyvinyl alcohol, propylene glycol, shellac, sodium chloride, talc, titanium dioxide, and FD&C red #40 lake. The 6 mg, 12 mg, 18 mg, 30 mg, 36 mg, and 42 mg extendedrelease tablets also contain FD&C yellow #6 lake. The 6 mg, 12 mg, 24 mg, and 36 mg extended-release tablets also contain FD&C blue #2 lake. The 18 mg extended-release tablets also contain carmine.

Manufacturer

Teva Neuroscience, Inc.: Parsippany, NJ 07054 USA.

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Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Austedo only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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