Austedo

What is Austedo?

Austedo (deutetrabenazine) reduces the amount of certain chemicals in the body that are overly active in people with Huntington's disease.

Austedo is used to treat involuntary muscle movements (chorea) caused by Huntington's disease. Deutetrabenazine is not a cure for Huntington's disease and will not treat other symptoms of this condition.

Austedo is also used to treat symptoms of tardive dyskinesia, 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).

This medicine is not a permanent cure for involuntary movement disorders.

Important information for Austedo

You should not use Austedo 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.

Your doctor will need to check your progress while you are using Austedo.

Before Taking Austedo

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;

• liver disease; or

• if you have recently taken tetrabenazine (Xenazine) or valbenazine (Ingrezza).

Do not use Austedo if you have taken reserpine (Serpalan, Renese-R) 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, rasagiline, selegiline, tranylcypromine, and others.

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); or

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

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 deutetrabenazine 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 should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

It is not known whether deutetrabenazine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed while using deutetrabenazine. Ask your doctor about any risk.

Austedo is not approved for use by anyone younger than 18 years old.

How should I take Austedo?

Take Austedo exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

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

Austedo is usually taken 1 or 2 times per day with food and a whole glass of water.

Do not crush, chew, or break a tablet. Swallow the tablet whole. Tell your doctor if you have trouble swallowing the tablet whole.

Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Do not stop taking this medicine without first asking your doctor. 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, heat, and light.

Austedo dosing information

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

Comments:
-Determine the dose for each patient based on chorea 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 treatment interruption of greater than 1 week; resume treatment at the previous maintenance dose without titration if treatment interruption is less than 1 week.

Use: Treatment of chorea associated with Huntington's disease.

What happens if I miss a dose of Austedo?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose of Austedo?

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

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

What should I avoid while taking Austedo?

This medicine may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

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.

Report any new or worsening symptoms to your doctor, such as: crying spells, changes in weight or appetite, feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, or if you feel hopeless, guilty, extremely tired, irritable, hostile, aggressive, or have thoughts about suicide or hurting yourself.

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

Call your doctor at once if you have:

• pain or burning when you urinate;

• 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;

• feeling tired;

• 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?

Austedo can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Using deutetrabenazine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can interact with deutetrabenazine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.

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.