Ingrezza (valbenazine)

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

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.

The most common side effect of Ingrezza is sleepiness (somnolence).

Other common side effects include:

• changes in balance (balance problems, dizziness) or an increased risk of falls
• headache
• feelings of restlessness
• constipation
• blurred vision
• dry mouth

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.

• Take Ingrezza exactly as your healthcare provider tells you to. Your healthcare provider will tell you how much Ingrezza to take and when to take it.
• Do not stop taking Ingrezza without talking to your healthcare provider first.
• Ingrezza can be taken with or without food.
• If you take too much Ingrezza, call your poison control center at 1-800-222-1222.

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

Do not take Ingrezza if you:

• are allergic to valbenazine, or any of the ingredients in Ingrezza. See the end of this Patient Information leaflet for a complete list of ingredients in Ingrezza.

Before taking Ingrezza, tell your healthcare provider about all of your medical conditions including if you:

• have liver problems
• have heart disease that is not stable, have heart failure or recently had a heart attack
• have an irregular heart rhythm or heartbeat (QT prolongation, heart arrhythmia)
• are pregnant or plan to become pregnant. Ingrezza may harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Ingrezza passes into your breast milk. Do not breastfeed during treatment with Ingrezza and for 5 days after the final dose. Talk to your healthcare provider about the best way to feed your baby during treatment with Ingrezza.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Taking Ingrezza with certain other medicines may cause serious side effects. Do not start any new medicines while taking Ingrezza without talking to your healthcare provider first.