The first FDA-approved treatment for adults with tardive dyskinesia (TD)

INGREZZA
A treatment specifically designed to help reduce the uncontrollable movements of tardive dyskinesia (TD)

Click the Q&A below for information about INGREZZA™ (valbenazine) capsules

  • What is TD?

    Tardive dyskinesia (TD) means having movements in the body that you can’t control.

    It is associated with taking certain medications, such as antipsychotics, that help control dopamine, a chemical in the brain. INGREZZA can help reduce these uncontrollable movements.

    TD is often seen in the lips, jaw, tongue, and eyes. It can also affect other parts of the body, including the upper body, arms, hands, torso, legs, and feet.


    Talk to your doctor if you have questions about TD or INGREZZA.

  • What is INGREZZA?

    INGREZZA is a medicine that was specifically designed to treat TD.

    It is the first prescription medicine FDA-approved to treat adults with movements in the face, tongue, or other body parts that cannot be controlled (TD). It is not known if INGREZZA is safe and effective in children.

    INGREZZA is taken once a day in capsule form, and is available in two different doses.


    Talk to your doctor if you have questions about TD or INGREZZA.

  • How does INGREZZA work in my body?

    Because INGREZZA was specifically designed for TD, it is believed to work directly in the region of the brain that causes uncontrollable movements.

    TD is likely caused by having irregular dopamine signaling in the brain, and INGREZZA is believed to reduce this signaling.


    Talk to your doctor if you have questions about TD or INGREZZA.

  • Did INGREZZA improve uncontrollable movements in clinical trials?

    INGREZZA improved the uncontrollable movements of TD by ~30% in a 6-week clinical trial.

    Study objective: To measure the difference in people’s uncontrollable movements at the beginning of the study and at the end of the study.

    Who participated: 234 people with moderate to severe TD. Results were based on 79 people taking the recommended dose of 80 mg.

    Underlying disorders: People had a clinical diagnosis of schizophrenia, schizoaffective disorder, or a mood disorder.

    Reductions in uncontrollable movements were seen as early as 2 weeks.

    Reduction in
    uncontrollable
    movements


    Talk to your doctor if you have questions about TD or INGREZZA.

  • Will INGREZZA maintain reductions in uncontrollable movements over time?

    INGREZZA maintained uncontrollable movement reductions through 48 weeks.

    After completing the 6-week trial, participants were able to enroll in a 42-week extension period. Results based on 63 people taking the recommended dose of 80 mg.

    The difference in people’s uncontrollable movements with INGREZZA was studied for a total of 48 weeks.

    Reduction in
    uncontrollable
    movements


    Talk to your doctor if you have questions about TD or INGREZZA.

  • What are the side effects of INGREZZA?

    In clinical trials, the most common side effect was sleepiness.

    Other side effects included:

    • Changes in balance 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.

    INGREZZA may cause serious side effects, including sleepiness and heart rhythm problems.

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


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

  • How will INGREZZA impact my other medications?

    In clinical trials, people were generally allowed to stay on their stable medications, including antipsychotics.

    No overall changes in safety measures were observed for bipolar disorder, schizophrenia, schizoaffective disorders, or major depression.


    Talk to your doctor if you have questions about TD or INGREZZA.

  • How should I take INGREZZA?

    Take INGREZZA exactly as your doctor tells you.

    He or she will tell you how much INGREZZA to take and when to take it. Do not stop taking INGREZZA without talking to your doctor first.

    You can take INGREZZA with or without food. If you take too much INGREZZA, call your poison control center at 1-800-222-1222.


    Talk to your doctor if you have questions about TD or INGREZZA.

  • What should I tell my doctor before taking INGREZZA?

    Before taking INGREZZA, tell your doctor about all of your medical conditions, including if you:

    • Have liver problems
    • Have heart issues
    • Have an irregular heart rhythm or heartbeat
    • Are pregnant or plan to become pregnant
    • Are breastfeeding or plan to breastfeed

    Tell your doctor about all prescription and over-the-counter medicines, vitamins, and herbal supplements that you take.

    Taking INGREZZA with certain other medicines may cause serious side effects.


    Don't start any new medicines while taking INGREZZA without talking to your doctor first.

  • Is there patient support for INGREZZA?

    Yes. The INBRACE™ Support Program can verify your insurance coverage for INGREZZA and coordinate delivery of your prescription directly to a location of your choosing.

    The INBRACE™ Support Program may also be able to help with financial assistance and product support for INGREZZA. Call 84-INGREZZA (844-647-3992) for more information.


    Talk to your doctor if you have questions about TD or INGREZZA.

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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

INGREZZA may cause serious side effects, including:

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

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 may report side effects to FDA at 1-800-FDA-1088.

Please see INGREZZA full Prescribing Information.

VIEW FULL IMPORTANT SAFETY INFORMATION

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

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.

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 may report side effects to FDA at 1-800-FDA-1088.

Please see INGREZZA full Prescribing Information.

IMPORTANT SAFETY INFORMATION PRESCRIBING INFORMATION

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