About
INGREZZA

INGREZZA for TD

What is INGREZZA?

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 [TD]).

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

INGREZZA was designed to treat TD

INGREZZA is thought to work directly in the region of the brain that causes the uncontrollable movements of TD

How does INGREZZA® (valbenazine) capsules work?

TD is associated with long-term use of certain medications, such as antipsychotics, that can create abnormal dopamine signaling in the brain

How does INGREZZA® (valbenazine) capsules work?

INGREZZA is believed to reduce this abnormal dopamine signaling

  • Dopamine is a chemical in the brain involved in controlling movement

Effectiveness of INGREZZA in tardive dyskinesia

INGREZZA reduced uncontrollable movements at 6 weeks

  • INGREZZA was studied in a 6-week clinical trial

  • The study measured the difference in people's uncontrollable movements from the beginning of the study and at 6 weeks, while observing the effect at certain times throughout the study

  • People in the study had moderate to severe TD and a physician's diagnosis of one of the following:

    ‐ Schizophrenia

    ‐ Schizoaffective disorder

    ‐ Mood disorder

INGREZZA® (valbenazine) capsules improved TD movements at 6 weeks INGREZZA® (valbenazine) capsules reduced TD movements in as early as 2 weeks
a A total of 234 people participated in the study. Results were based on 79 people taking the recommended dose of 80 mg in a post hoc analysis.

INGREZZA reduced the uncontrollable movements of TD through almost 1 year

  • After completing the 6-week trial, participants were allowed to enroll in a 42-week extension period
  • The change in people’s uncontrollable movements with INGREZZA was studied for a total of 48 weeks
39% reduction in TD movements with INGREZZA® (valbenazine) capsules after about 1 year
b Results were based on 63 people taking the recommended dose of 80 mg in a post hoc analysis.

Talk to your doctor if you have questions about INGREZZA

Side effects while taking INGREZZA

INGREZZA® (valbenazine) capsules Sleepiness Side Effect

The most common side effect was sleepiness

It is common to experience some side effects while taking a new medication. In clinical trials, people did experience some side effects while taking INGREZZA.

heart icon image

INGREZZA may cause serious side effects, including:

  • Sleepiness
  • Heart rhythm problems
INGREZZA® (valbenazine) capsules Side Effects

Other side effects included:

  • Changes in balance (balance problems, dizziness) or an increased risk of falls

  • Headache

  • Feelings of restlessness

  • Dry mouth

  • Constipation

  • Blurred vision

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

Tell your doctor right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you faint

Do you think you are feeling side effects while taking INGREZZA?

  • Call your doctor for medical advice about side effects
  • You may report side effects to FDA at 1-800-FDA-1088
  • Why INGREZZA for TD?

    INGREZZA for TD

    What is INGREZZA?

    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 [TD]).

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

    INGREZZA was designed to treat TD

    INGREZZA is thought to work directly in the region of the brain that causes the uncontrollable movements of TD

    How does INGREZZA® (valbenazine) capsules work?

    TD is associated with long-term use of certain medications, such as antipsychotics, that can create abnormal dopamine signaling in the brain

    How does INGREZZA® (valbenazine) capsules work?

    INGREZZA is believed to reduce this abnormal dopamine signaling

    • Dopamine is a chemical in the brain involved in controlling movement
  • Is INGREZZA effective?

    Effectiveness of INGREZZA in tardive dyskinesia

    INGREZZA reduced uncontrollable movements at 6 weeks

    • INGREZZA was studied in a 6-week clinical trial

    • The study measured the difference in people's uncontrollable movements from the beginning of the study and at 6 weeks, while observing the effect at certain times throughout the study

    • People in the study had moderate to severe TD and a physician's diagnosis of one of the following:

      ‐ Schizophrenia

      ‐ Schizoaffective disorder

      ‐ Mood disorder

    INGREZZA® (valbenazine) capsules improved TD movements at 6 weeks INGREZZA® (valbenazine) capsules reduced TD movements in as early as 2 weeks
    a A total of 234 people participated in the study. Results were based on 79 people taking the recommended dose of 80 mg in a post hoc analysis.

    INGREZZA reduced the uncontrollable movements of TD through almost 1 year

    • After completing the 6-week trial, participants were allowed to enroll in a 42-week extension period
    • The change in people’s uncontrollable movements with INGREZZA was studied for a total of 48 weeks
    39% reduction in TD movements with INGREZZA® (valbenazine) capsules after about 1 year
    b Results were based on 63 people taking the recommended dose of 80 mg in a post hoc analysis.

    Talk to your doctor if you have questions about INGREZZA

    Side effects while taking INGREZZA

    INGREZZA® (valbenazine) capsules Sleepiness Side Effect

    The most common side effect was sleepiness

    It is common to experience some side effects while taking a new medication. In clinical trials, people did experience some side effects while taking INGREZZA.

    heart icon image

    INGREZZA may cause serious side effects, including:

    • Sleepiness
    • Heart rhythm problems
    INGREZZA® (valbenazine) capsules Side Effects

    Other side effects included:

    • Changes in balance (balance problems, dizziness) or an increased risk of falls

    • Headache

    • Feelings of restlessness

    • Dry mouth

    • Constipation

    • Blurred vision

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

    Tell your doctor right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you faint

    Do you think you are feeling side effects while taking INGREZZA?

    • Call your doctor for medical advice about side effects
    • You may report side effects to FDA at 1-800-FDA-1088