Deutetrabenazine (Oral route)
Depression and Suicidality in Patients with Huntington's DiseaseDeutetrabenazine can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington disease. Anyone considering the use of deutetrabenazine must balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Patients, their caregivers, and families should be informed of the risk of depression and suicidality and should be instructed to report behaviors of concern promptly to the treating physician.Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in Huntington’s disease. Deutetrabenazine is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression .
Central Nervous System Agent
Uses of This Medicine:
Deutetrabenazine is used to treat movement disorders, including tardive dyskinesia and chorea caused by Huntington disease. Deutetrabenazine works in the central nervous system (CNS) to prevent the absorption of certain chemicals (eg, dopamine, serotonin).
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of deutetrabenazine in the pediatric population. Safety and efficacy have not been established.
Although appropriate studies on the relationship of age to the effects of deutetrabenazine have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving deutetrabenazine.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Methylene Blue
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Arsenic Trioxide
- Inotuzumab Ozogamicin
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Akathisia (a movement disorder), including agitation and restlessness, history of or
- Depression, history of or
- Heart rhythm problems (eg, QT prolongation), history of or
- Suicidal thoughts or behavior—Use with caution. May make these conditions worse, especially in patients with Huntington's disease.
- Bradycardia (slow heartbeat) or
- Breast cancer, history of
- Hypokalemia (low potassium levels in the blood) or
- Hypomagnesemia (low magnesium levels in the blood)—Use with caution. May increase risk for serious side effects.
- Depression, untreated or
- Liver disease or
- Suicidal thoughts or behavior, active—Should not be used in patients with these conditions.
Proper Use of This Medicine:
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Swallow the tablet whole. Do not crush, break, or chew it.
This medicine should be taken with food.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For chorea:
- Adults—At first, 6 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 48 mg per day. If your dose is 12 mg or more per day, take the tablets 2 times a day in equal doses.
- Children—Use and dose must be determined by your doctor.
- For tardive dyskinesia:
- Adults—At first, 12 milligrams (mg) per day taken as two equal doses (6 mg two times a day). Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 48 mg per day.
- Children—Use and dose must be determined by your doctor.
- For chorea:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you stop taking this medicine for more than 7 days, do not take another dose until you talk to your doctor.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to see if the medicine is working properly and to allow for changes in the dose.
Deutetrabenazine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed, especially if they have a condition called Huntington's disease. If you or your caregiver notice any of these side effects, tell your doctor right away.
Do not take this medicine if you are also taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®), or tranylcypromine (Parnate®) within 14 days of each other. If you have questions, check with your doctor.
Do not take this medicine if you are also taking reserpine (Serpalan® or Renese®-R). Wait at least 20 days after stopping reserpine before starting deutetrabenazine. If you have questions, check with your doctor.
Do not take this medicine if you are also taking tetrabenazine (Xenazine®) or valbenazine (Ingrezza®). Take deutetrabenazine one day after stopping tetrabenazine. If you have questions, check with your doctor.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, such as QT prolongation.
Check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).
Check with your doctor right away if you have an inability to sit still, need to keep moving, or restlessness. These could be symptoms of a movement disorder called akathisia.
This medicine may cause parkinsonism (a movement disorder). Check with your doctor right away if you have difficulty swallowing, loss of balance control, mask-like face, shuffling walk, slowed movements, slurred speech, stiffness of the arms and legs, tic-like or jerky movements of the head, face, mouth, and neck, or trembling and shaking of the fingers and hands.
This medicine may cause drowsiness, trouble with thinking, or trouble with controlling movements. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Make sure your doctor knows if you are using amiodarone (Cordarone®), chlorpromazine (Thorazine®), moxifloxacin (Avelox®), procainamide (Pronestyl®), quinidine, sotalol (Betapase®), thioridazine (Mellaril®), or ziprasidone (Geodon®). Using any of these medicines together with deutetrabenazine may cause serious side effects.
Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or worsens, check with your doctor.
This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates or medicine for seizures, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. Check with your doctor before taking any of the above while you are using this medicine.
Side Effects of This Medicine:
- More common
- Body aches or pain
- difficulty with breathing
- difficulty with swallowing
- dry mouth
- feeling sad or empty
- inability to sit still
- lack of appetite
- loss of balance control
- loss of interest or pleasure
- mask-like face
- need to keep moving
- relaxed and calm feeling
- shuffling walk
- sleepiness or unusual drowsiness
- slow movement or reflexes
- slurred speech
- stiffness of the arms and legs
- tic-like (jerky) movements of the head, face, mouth, and neck
- trembling and shaking of the fingers and hands
- trouble concentrating
- trouble sleeping
- trouble with balance
- unusual tiredness or weakness
- Less common
- problems passing stools
- Symptoms of overdose
- Blurred vision
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fixed position of the eye
- inability to move the eyes
- increased blinking or spasms of the eyelid
- mood or mental changes
- seeing, hearing, or feeling things that are not there
- shakiness in the legs, arms, hands, or feet
- sticking out of the tongue
- trembling or shaking of the hands or feet
- uncontrolled twisting movements of the neck, trunk, arms, or legs
- unusual facial expressions
- More common
- large, flat, blue patches on the skin
- Less common
- Muscle aches
- sore throat
- stuffy or runny nose
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 6/18/2019