deutetrabenazine

What is the most important information I should know about deutetrabenazine?

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.

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

What is deutetrabenazine?

Deutetrabenazine reduces the amount of certain chemicals in the body that are overly active in people with Huntington's disease.

Deutetrabenazine 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.

Deutetrabenazine is 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).

Deutetrabenazine is not a permanent cure for involuntary movement disorders.

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

What should I discuss with my healthcare provider before taking deutetrabenazine?

• 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 deutetrabenazine 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.

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 deutetrabenazine 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.

How should I take deutetrabenazine?

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.

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.

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

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?

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 deutetrabenazine?

What are the possible side effects of deutetrabenazine?

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.

• 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 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 deutetrabenazine?

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.

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 your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about deutetrabenazine.