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.

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

It is the first and only 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.

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.

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.

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.

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.

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.

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.

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.

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.