Deutetrabenazine may increase the risk of depression or suicidal thoughts (thinking about harming or killing yourself or planning or trying to do so) in people with Huntington's disease (an inherited disease that causes the progressive breakdown of nerve cells in the brain). Tell your doctor if you have or have ever had depression and if you have or have ever had thoughts about harming or killing yourself. If you have Huntington's disease and are depressed or have suicidal thoughts, your doctor will probably tell you not to take deutetrabenazine. You, your family, or caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression, thoughts about harming or killing yourself or planning or trying to do so, extreme worry, agitation, difficulty falling asleep or staying asleep, aggressive or hostile behavior, irritability, acting without thinking, severe restlessness, anxiety, changes in body weight, loss of interest in social interactions, difficulty paying attention, or any other unusual changes in behavior. Be sure that your family or caregiver checks on you regularly and knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.
Keep all appointments with your doctor. Your doctor will probably want to talk with you about your mental health while you are taking this medication.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with deutetrabenazine and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) or the manufacturer's website to obtain the Medication Guide.
WHY is this medicine prescribed?
Deutetrabenazine is used to treat chorea (sudden movements that you cannot control) caused by Huntington's disease (an inherited disease that causes the progressive breakdown of nerve cells in the brain). It is also used to treat tardive dyskinesia (uncontrollable movement of the face, tongue, or other body parts). Deutetrabenazine is in a class of medications called vesicular monoamine transporter 2 (VMAT2) inhibitors. It works by changing the activity of certain natural substances in the brain that affect nerves and muscles.
HOW should this medicine be used?
Deutetrabenazine comes as a tablet to take by mouth. For patients with Huntington's disease, it is usually taken with food once a day at first and then increased to twice a day. For patients with tardive dyskinesia, it is usually taken with food twice daily. Take deutetrabenazine at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take deutetrabenazine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the tablets whole; do not split, chew, or crush them.
Your doctor will probably start you on a low dose of deutetrabenazine and gradually increase your dose, not more than once every week.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking deutetrabenazine,
tell your doctor and pharmacist if you are allergic to deutetrabenazine, any other medications, or any of the ingredients in deutetrabenazine tablets. It works by changing the activity of certain natural substances in the brain. Ask your pharmacist for a list of the ingredients.
tell your doctor if you are taking reserpine, tetrabenazine (Xenazine), valbenazine (Ingrezza), or a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking a monoamine oxidase inhibitor within the past 2 weeks or stopped taking reserpine in the last 20 days. Your doctor will probably tell you that you should not take deutetrabenazine.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: medications for anxiety; antidepressants such as bupropion (Aplenzin, Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem, Selfemra), and paroxetine (Brisdelle, Paxil, Pexeva); antipsychotics such as chlorpromazine, haloperidol (Haldol), olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, and ziprasidone (Geodon); certain medications for irregular heartbeats such as amiodarone (Nexterone, Pacerone), procainamide, quinidine (in Nuedexta), and sotalol (Betapace, Sorine, Sotylize); moxifloxacin (Avelox); medications for seizures; sedatives, sleeping pills, or tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have liver disease. Your doctor will probably tell you not to take deutetrabenazine.
tell your doctor if you have or have ever had long QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause fainting or sudden death) or another type of irregular heart beat or heart rhythm problem. Also tell your doctor if you have low blood levels of magnesium or potassium in your blood or breast cancer.
tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking deutetrabenazine, call your doctor.
you should know that deutetrabenazine may make you drowsy or cause tiredness. Do not drive a car or operate machinery until you know how this medication affects you.
you should know that alcohol can add to the drowsiness caused by this medication. Do not drink alcohol while taking deutetrabenazine.
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
If you miss taking deutetrabenazine for more than a week, talk to your doctor before starting to take it again. You will probably have to restart taking it at a lower dose.
What SIDE EFFECTS can this medicine cause?
Deutetrabenazine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
pain or burning upon urination
upper respiratory infection
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop taking deutetrabenazine and call your doctor immediately or get emergency medical treatment:
fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness
difficulty moving, or keeping your balance
irregular or rapid heartbeat
Deutetrabenazine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( Web Site ) or by phone (1-800-332-1088).
What should I know about STORAGE and DISPOSAL of this medication?
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. Web Site
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 ( Web Site) for more information if you do not have access to a take-back program.
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at Web Site. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include the following:
twisting or jerking movements
rapid eye movement
hallucinations (seeing thing or hearing voices that do not exist)
redness of the skin
What OTHER INFORMATION should I know?
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.
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