Austedo & Austedo XR

Austedo (deutetrabenazine) tablets are used to treat involuntary movement disorders, including tardive dyskinesia (TD) and chorea caused by Huntington's disease. Austedo works by balancing certain natural substances (neurotransmitters) in the brain to help control muscles and body movement.

Austedo belongs to a class of drugs called VMAT2 inhibitors (vesicular monoamine transporter 2 inhibitors).

Austedo tablets are taken twice daily with food, and Austedo XR tablets are an extended-release tablet taken once daily with or without food. A titration kit is also available to help you gradually increase to your prescribed dose over the first few weeks of treatment.

Austedo has two FDA-approved uses:

• Chorea caused by Huntington's disease: Huntington's disease is an inherited condition that causes the progressive breakdown of nerve cells in the brain. Chorea refers to sudden, uncontrolled movements that are a hallmark symptom of this disease.
• Tardive dyskinesia (TD): This is a movement disorder that causes uncontrollable, repetitive movements of the face, tongue, and other parts of the body. It most commonly occurs as a side effect of long-term use of certain medications, particularly antipsychotics.

Standard tablets (Austedo)

• Take by mouth twice daily with food.
• Take at the same time each day.
• Swallow the tablet whole with a glass of water. Do not split, crush, or chew.
• Keep taking it unless your doctor tells you to stop.

Extended-release tablets (Austedo XR)

• Take by mouth once daily.
• Can be taken with or without food.
• Swallow whole. Do not split, crush, or chew.

Note: You may notice the extended-release tablet shell in your stool. This is normal and does not mean you did not receive your full dose. The medicine is released gradually as the tablet passes through your digestive system.

Starting dose and adjustments

Your doctor will typically start you on a low dose and increase it gradually, no more than once per week, based on how well the medication is working and any side effects you experience. Always tell your doctor how you are feeling during treatment.

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.

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

Austedo dose

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

Austedo XR dose

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/dayImportant Administration Instructions:

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

General dosing information

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 modifications may be required when taking other medications due to drug interactions.

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.

Boxed warning for depression and suicidality in patients with Huntington’s disease

Austedo and Austedo XR can cause serious mental health effects in people with Huntington's disease, including depression, suicidal thoughts, and suicidal behavior.

Do not start taking this medicine if you have Huntington's disease and are currently experiencing depression that is untreated or not well controlled, or if you are having thoughts of suicide.

Watch closely for any changes in your mood, behavior, thoughts, or feelings, particularly when you first start treatment or after a dose change. Contact your healthcare provider right away if you notice any of the following symptoms, especially if they are new, getting worse, or concerning to you:

• Feeling sad or tearful
• Losing interest in friends, family, or activities you previously enjoyed
• Sleeping much more or much less than usual
• Feeling worthless or unimportant
• Feeling guilty for no clear reason
• Feeling hopeless or like things will not get better
• Feeling more irritable, angry, or aggressive than usual
• Noticeable increase or decrease in appetite, or significant unexplained weight change
• Difficulty concentrating or paying attention
• Feeling persistently tired or drowsy
• Thoughts of hurting yourself or ending your life

Warnings for all patients

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 tablets and XR tablets 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 this medicine 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 the Interactions section for more interactions with this medicine.

You should not use Austedo if you are allergic to the active ingredient, deutetrabenazine, inactive ingredients, or if you have:

• untreated or uncontrolled depression;
• thoughts about suicide or hurting yourself;
• if you have recently taken tetrabenazine or valbenazine; or
• liver impairment.

Do not use this medicine 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 this medicine 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 this medicine may further increase this risk. However, the benefits of taking this medicine (improvement in daily living) may outweigh any suicidal risks.

Taking this medicine 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.

Common side effects

Common Austedo side effects include:

• Drowsiness or tiredness
• Diarrhea
• Dry mouth
• Trouble sleeping (insomnia)
• Sore throat, congestion, or runny nose

Serious side effects: contact your doctor right away

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 for Huntington's disease. 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 other 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.

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.

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

Who is eligible for the Austedo Coupon or Copay Card?

You are eligible for the Austedo Copay Card if you have commercial or private insurance, a valid prescription, and are a resident of the United States or the United States territories.

You are not eligible for an Austedo Copay Card if you are enrolled in Medicare, Medigap, Medicaid, VA, DOD, TRICARE, Puerto Rico Government Health Insurance Plan, and Medicare-eligible patient enrolled in an employer-sponsored health plan or prescription drug benefit program for retirees.

How can I apply for the Austedo Copay Card?

You can apply for the Austedo Copay Card or Coupon online; there is a link on the Austedo Price Guide page.

Take the missed dose as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and continue your regular schedule. Do not take two doses at once to make up for a missed one.

If you miss taking Austedo for more than a week, contact your doctor before restarting. You will likely need to restart at a lower dose.

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.

Many drugs can interact with the active ingredient deutetrabenazine. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

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.

Do not take these medications with Austedo

Reserpine (a blood pressure medicine)

• If you have been taken reserpine, you must wait at least 20 days after stopping it before starting Austedo

MAOIs medicines

• You must wait 14 days after stopping an MAOI before starting to take Austedo
• Examples of MAOIs are selegiline, phenelzine, tranylcypromine, isocarboxazid

Tetrabenazine or Valbenazine (similar medicines for movement disorders)

• Tetrabenazine or Valbenazine should not be taken by patients taking with Austedo or Austedo XR
• Austedo or Austedo XR may be started the day following discontinuation of tetrabenazine

Medications That Require a Lower Dose of Austedo

If you take any of these medications, your doctor will limit your Austedo dose to 36 mg per day instead of the usual maximum of 48 mg per day:

• Paroxetine (Paxil) — for depression or anxiety
• Fluoxetine (Prozac) — for depression or anxiety
• Bupropion (Wellbutrin, Zyban) — for depression or to help quit smoking
• Quinidine — for heart rhythm problems

These medications increase the amount of Austedo in your body, so a lower dose is needed to stay safe.

Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

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.

• Store at room temperature between 68 and 77 degrees F (20 to 25 degrees C).
• Keep away from light, excess heat, and moisture. Do not store in the bathroom.
• Keep the container tightly closed. Do not remove the desiccant packet inside the container as it helps keep the medication dry.

Austedo Teva Pharmaceuticals, Inc.