Is your day being affected by movements you can't control?

If you have persistent, uncontrollable movements and have taken certain mental health medicines, it could be tardive dyskinesia (TD).

See what TD looks like
See what TD looks like

Sustained satisfaction among patients who had been using Valbenazine for about two years.

*55 of 56 patients in a rollover study of patients taking Valbenazine for 48 weeks after completing long-term KINECT 3 & KINECT 4 studies. Based on Patient Satisfaction Questionnaire given to patients at beginning and end of treatment.

With Tardivex, you can keep taking most mental health medicines.

In a clinical study, psychiatric status remained stable overall in people taking Tardivex for TD, including those who were also taking medicine for:

  • Depression
  • Bipolar disorder
  • Schizophrenia/​schizoaffective disorder
  • Anxiety disorder
Learn more about treating TD with Tardivex
Learn more about treating TD with Tardivex

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Important Information

Approved Uses

Tardivex (valbenazine) capsules are prescription medicines used to treat adults with:

movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).
involuntary movements (chorea) of Huntington’s disease. Tardivex do not cure the cause of involuntary movements, and do not treat other symptoms of Huntington’s disease, such as problems with thinking or emotions.

It is not known if Tardivex is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Tardivex can cause serious side effects in people with Huntington’s disease, including: depression, suicidal thoughts, or suicidal actions. Tell your healthcare provider before you start taking Tardivex if you have Huntington’s disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when Tardivex is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself.

Do not take Tardivex if you:

are allergic to valbenazine, or any of the ingredients in Tardivex.
 

Tardivex can cause serious side effects, including:

  • Allergic reactions. Allergic reactions, including an allergic reaction that causes sudden swelling called angioedema, can happen after taking the first dose or after many doses of Tardivex. Signs and symptoms of allergic reactions and angioedema include: trouble breathing or shortness of breath, swelling of your face, lips, eyelids, tongue, or throat, or other areas of your skin, trouble with swallowing, or rash, including raised, itchy red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Stop taking Tardivex and go to the nearest emergency room right away if you develop these signs and symptoms of allergic reactions and angioedema.
  • Sleepiness and tiredness that could cause slow reaction times (somnolence and sedation). Do not drive a car or operate dangerous machinery until you know how Tardivex affects you. Drinking alcohol and taking other medicines may also cause sleepiness during treatment with Tardivex.
  • Heart rhythm problems (QT prolongation). Tardivex may cause a heart rhythm problem known as QT prolongation. You have a higher chance of getting QT prolongation if you also take certain other medicines during treatment with Tardivex. Tell your healthcare provider right away if you develop any signs or symptoms of QT prolongation, including: fast, slow, or irregular heartbeat (heart palpitations), shortness of breath, dizziness or lightheadedness, or fainting or feeling like you are going to faint.
  • Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, irregular pulse or blood pressure, increased sweating, or very fast or uneven heartbeat.
  • Parkinson-like symptoms. Symptoms include: body stiffness, drooling, trouble moving or walking, trouble keeping your balance, shaking (tremors), or falls.

Before taking Tardivex, tell your healthcare provider about all of your medical conditions including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Make sure you tell all of your healthcare providers that you are taking Tardivex. Taking Tardivex with certain other medicines may cause serious side effects. Especially tell your healthcare provider if you: take digoxin or take or have taken a monoamine oxidase inhibitor (MAOI) medicine. You should not take Tardivex if you are taking, or have stopped taking, a MAOI within the last 14 days.

The most common side effects of Tardivex in people with tardive dyskinesia are sleepiness and tiredness.

The most common side effects of Tardivex in people with chorea associated with Huntington’s disease include sleepiness and tiredness, raised itchy red areas on your skin (hives), rash, and trouble getting to sleep or staying asleep.

These are not all of the possible side effects of Tardivex. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.

Dosage Forms and Strengths: Tardivex are available in 40 mg  capsules.