Deutetrabenazine

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. Also, tell your doctor if you have emotional or mental problems such as nervousness, anxiety, anger, agitation, or psychosis, (difficulty thinking clearly, communicating, understanding reality, and behaving appropriately). 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 (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

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.

Deutetrabenazine comes as a tablet or extended release tablet to take by mouth. The tablet is usually taken twice a day with food. The extended release tablet is usually taken once a day with or without food. 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 and extended release 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, depending on how well the medication works for you and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

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 or extended release tablets. Ask your pharmacist for a list of the ingredients.
• Some medications should not be taken with deutetrabenazine. Other medications may cause dosing changes or extra monitoring when taken with deutetrabenazine. Make sure you have discussed any medications you have recently taken, are currently taking or plan to take before starting deutetrabenazine with your doctor and pharmacist. Before starting, stopping or changing any medications while taking deutetrabenazine, please get the advice of your doctor or pharmacist. Your doctor may need to change the dose of your medicine(s) or monitor you carefully for side effects.
• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue; phenelzine (Nardil), rasagiline (Azilect), selegiline (Emsam, Zelapar), and tranylcypromine (Parnate).
• tell your doctor if you have liver disease. Your doctor will probably tell you not to take deutetrabenazine.
• tell your doctor if you or anyone in your family has or has 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, or if you have or ever had breast cancer. Also tell your doctor if you have low blood levels of magnesium or potassium in your blood.
• 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. Ask your doctor about the safe use of alcoholic beverages while you are taking deutetrabenazine.

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

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.

Deutetrabenazine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• constipation
• dry mouth
• tiredness
• problems sleeping
• pain or burning upon urination
• bruising
• congestion, sore throat, or runny nose
• dizziness

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
• shaking, stiffness, or difficulty moving or keeping your balance
• falls
• irregular or rapid heartbeat
• fainting

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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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. https://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 (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. 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
• nausea
• vomiting
• sweating
• sedation
• confusion
• diarrhea
• hallucinations (seeing thing or hearing voices that do not exist)
• redness of the skin
• uncontrollable shaking

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

The extended-release tablet does not dissolve in the stomach after swallowing. It slowly releases the medicine as it passes through your digestive system. You may notice the tablet shell in your stool. This is normal and does not mean that you did not receive the full dose of medication.

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.

• Austedo^®
• Austedo XR^®