INGREZZA® (valbenazine) capsules is an FDA-approved treatment for adults with the uncontrollable movements of tardive dyskinesia (TD).

#1 most prescribed treatment for tardive dyskinesia

INGREZZA is proven to reduce uncontrollable body movements from tardive dyskinesia (TD)

In a clinical study, about 70% of patients taking INGREZZA 80 mg saw reduction in TD movements at 6 weeks*

  • This post-clinical study evaluation included 70 patients taking INGREZZA 80 mg, measuring uncontrollable movements before starting treatment and at 6 weeks of treatment.

*Patients had at least a 1-point reduction on an uncontrollable movement severity scale at 6 weeks vs before treatment.

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The only once-daily treatment for adults with TD.

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Indication and Important Safety Information

Do not take INGREZZA if you are allergic to valbenazine, or any of the ingredients in INGREZZA.

Important Information

Approved Use

INGREZZA® (valbenazine) capsules is a prescription medicine used to treat adults with movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).

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

IMPORTANT SAFETY INFORMATION

Do not take INGREZZA if you:

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

INGREZZA may cause serious side effects, including:

  • Sleepiness (somnolence). Do not drive, operate heavy machinery, or do other dangerous activities until you know how INGREZZA affects you.
  • Heart rhythm problems (QT prolongation). INGREZZA may cause a heart problem known as QT prolongation.
  • Symptoms of QT prolongation may include:
    • fast, slow, or irregular heartbeat
    • shortness of breath
    • dizziness or fainting
  • Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you faint.
  • Parkinson-like symptoms. Symptoms include: shaking, body stiffness, trouble moving or walking, or keeping your balance.

Before taking INGREZZA, 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.

The most common side effect of INGREZZA is sleepiness (somnolence). Other side effects include changes in balance (balance problems, dizziness) or an increased risk of falls, headache, feelings of restlessness, dry mouth, constipation, and blurred vision.

These are not all of the possible side effects of INGREZZA. 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.

Please see accompanying INGREZZA full Product Information

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