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.

You should not use Austedo tablets or extended-release tablets if you have liver disease, untreated or uncontrolled depression, or if you have thoughts about suicide.

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.

Stay alert to changes in your mood, feelings, thoughts, or behaviors. Report any new or worsening symptoms to your doctor.

Some people have thoughts about suicide while taking Austedo. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Your doctor will need to check your progress while you are using 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 is usually taken 1 or 2 times per day with or without food and a whole glass of water.

Swallow the tablet whole and do not crush, chew, or break it. Tell your doctor if you have trouble swallowing the tablet whole.

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.

Usual Adult Dose for Huntington Disease:

-Initial Dose: 6 mg orally once a day
-Maintenance Dose: May increase dose in increments of 6 mg/day at weekly intervals.
-Maximum Dose: 48 mg/day in divided doses.
Use: For chorea associated with Huntington's disease

Usual Adult Dose for Tardive Dyskinesia:

-Initial Dose: 6 mg orally 2 times a day
-Maintenance Dose: May increase dose in increments of 6 mg/day at weekly intervals.
-Maximum Dose: 48 mg/day in divided doses
Use: For tardive dyskinesia

Comments:
-Determine the dose for each patient based on tardive dyskinesia reduction and tolerability.
-Administer total daily dosages of 12 mg or more in 2 divided doses.
-May discontinue this drug without tapering.
-Re-titrate dose when resuming this drug following therapy interruption of greater than 1 week; resume therapy at the previous maintenance dose without titration if treatment interruption is less than 1 week.
-For patients at risk for QT prolongation, assess the QT interval before and after increasing total dosage above 24 mg per day.

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.

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.

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.

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.

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.