Valbenazine may increase the risk of depression or suicidal thoughts (thinking about harming or killing yourself or planning or trying to do so). Tell your doctor if you have or have ever had depression, or other mental problems such as anxiety or psychosis (difficulty thinking clearly, communicating, understanding reality, and behaving appropriately) 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.
You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.Why is this medicine prescribed?
Valbenazine is used to treat tardive dyskinesia (uncontrollable movement of the face, tongue, or other body parts) and 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 and a sprinkle capsule to take by mouth. Take with or without food once a day. Take valbenazine at around the same time every day.
Take valbenazine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
If you are taking the sprinkle capsules, place a small amount (1 tablespoon) of soft food, such as applesauce, yogurt, or pudding in a cup or bowl. Open the capsules and sprinkle the contents on the soft food. Stir with the spoon and swallow the mixture right after you prepare it. Do not chew the beads. After swallowing the mixture, drink a glass (about 8 ounces) of water. If needed, unused mixtures of food and medication can be stored at room temperature for up to 2 hours. Discard unused mixtures.
Sprinkle capsules can also be swallowed whole with water. Do not crush or chew capsules or sprinkle capsules.
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.
What special precautions should I follow?
Before taking valbenazine,
- tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- 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 these 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 heartbeat 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?
Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.
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 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 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; or swelling of the face, lips, or mouth
- fast, slow, or irregular heartbeat; shortness of breath; dizziness; fainting or loss of consciousness
- fever, sweating, confusion, fast or irregular heartbeat, or muscle stiffness
- shaking; drooling; stiffness; difficulty moving, walking, or keeping your balance; or falling
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 ( https://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).
Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information. Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.orgWhat other information should I know?
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.