What is the most important information I should know about deutetrabenazine?
You should not use deutetrabenazine 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 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?
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;
- 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.
To make sure deutetrabenazine is safe for you, tell your doctor if you have ever had:
- depression, anxiety, nervousness, or agitation;
- a history of mental illness or psychosis;
- suicidal thoughts or actions;
- breast cancer;
- a heart rhythm disorder;
- a personal or family history of long QT syndrome; 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.
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 this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether deutetrabenazine passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.
Deutetrabenazine is not approved for use by anyone younger than 18 years old.
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. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Deutetrabenazine is usually taken 1 or 2 times per day with food and a whole glass of water.
Do not crush, chew, or break a deutetrabenazine tablet. Swallow it 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 deutetrabenazine without first asking your doctor.
Store at room temperature away from moisture, heat, and light.
If you stop taking deutetrabenazine for longer than 1 week, do not start taking it again without your doctor's advice.
What happens if I miss a dose?
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?
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 deutetrabenazine?
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.
What are the possible side effects of deutetrabenazine?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, crying spells, trouble concentrating, loss of interest in things you enjoyed before, changes in weight or appetite, 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:
- 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, especially if you use certain medicines at the same time, such as antibiotics, antifungal medicine, antidepressants, anti-malaria medicine, asthma inhalers, antipsychotic medicine, cancer medicine, certain HIV/AIDS medicine, heart or blood pressure medicine, or medicine to prevent vomiting.
Taking deutetrabenazine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, narcotic medication, muscle relaxer, or medicine for anxiety, depression, or seizures.
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with deutetrabenazine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Where can I get more information?
Your pharmacist can provide more information about deutetrabenazine.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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