Valbenazine

IMPORTANT WARNING:

Valbenazine 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. 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.

WHY is this medicine prescribed?

Valbenazine is used to treat tardive dyskinesia (uncontrollable movement of the face, tongue, or other body parts). Valbenazine is also 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). Valbenazine 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.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Valbenazine comes as a capsule to take by mouth. It is usually taken with or without food once a day. Take valbenazine at around the same time 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 valbenazine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of valbenazine and may increase your dose gradually every one or two weeks depending on how your body reacts to the medication.

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

What SPECIAL PRECAUTIONS should I follow?

Before taking valbenazine,

• tell your doctor and pharmacist if you are allergic to valbenazine, any other medications, or any of the ingredients in valbenazine capsules. Ask your pharmacist for a list of the ingredients.

• tell your doctor if you are taking the following medications or have stopped taking them within the last two weeks: monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), safinamide (Xadago), selegiline (Emsam, Zelapar), and tranylcypromine (Parnate).

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• The following nonprescription or herbal products may interact with valbenazine: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking valbenazine. Do not start any of this medications while taking valbenazine without discussing with your healthcare provider.

• tell your doctor if you have recently had a heart attack or if you or anyone else 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 have had heart failure or liver disease.

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking valbenazine, call your doctor.

• tell your doctor if you are breast-feeding or plan to breastfeed. You should not breastfeed while taking valbenazine and for 5 days after the final dose.

• you should know that this medication 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 valbenazine.

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.

What SIDE EFFECTS can this medicine cause?

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

• sleepiness
• tiredness
• restlessness
• nausea
• vomiting
• diarrhea
• joint or back pain
• headache
• constipation
• dry mouth
• difficulty urinating
• blurred vision

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• rash
• hives
• itching
• swelling of the face, lips, or mouth
• dizziness
• fainting or loss of consciousness
• shortness of breath
• fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness
• shaking, stiffness, or difficulty moving, walking, or keeping your balance
• falls

Valbenazine 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 (http://www.fda.gov/Safety/MedWatch) 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 excess heat and moisture (not in the bathroom).

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

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. http://www.upandaway.org

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 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.

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.