Deutetrabenazine is used in adults 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.

Deutetrabenazine is also used in adults 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).

Deutetrabenazine is not a permanent cure for involuntary movement disorders.

Deutetrabenazine may also be used for purposes not listed in this medication guide.

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

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

Deutetrabenazine 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 deutetrabenazine 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

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 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.

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

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.

Use: For tardive dyskinesia

You should not use deutetrabenazine if you are allergic to it, 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 deutetrabenazine 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.

Tell your doctor if you have or 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 deutetrabenazine may further increase this risk. However, the benefits of taking deutetrabenazine (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 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Avoid driving or hazardous activity until you know how deutetrabenazine 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: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people have thoughts about suicide while taking deutetrabenazine. 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 side effects of deutetrabenazine 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.

Deutetrabenazine 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 affect deutetrabenazine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.