Important Safety Information for patients

Please see Important Safety Information, including Boxed Warning, below.

Visit https://www.INGREZZA.com for more information on INGREZZA® (valbenazine) capsules.

Important Information
Approved Uses
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).
• involuntary movements (chorea) of Huntington’s disease. INGREZZA does not cure the cause of involuntary movements, and does not treat other symptoms of Huntington’s disease, such as problems with thinking or emotions.

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

IMPORTANT SAFETY INFORMATION
INGREZZA can cause serious side effects in people with Huntington’s disease, including: depression, suicidal thoughts, or suicidal actions. Tell a healthcare provider before you start taking INGREZZA if you have Huntington’s disease and are depressed (have untreated depression or depression not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is extra important when INGREZZA is started or dose is changed. Call a healthcare provider right away if you become depressed, have changes in mood or behavior, or thoughts of hurting yourself.

Do not take INGREZZA if you:
• are allergic to it or any of its ingredients

INGREZZA can cause serious side effects, including:
• Allergic reactions, including allergic reaction causing sudden swelling called angioedema, can happen after taking the first or many doses of treatment. Signs and symptoms of allergic reactions and angioedema include: trouble breathing or shortness of breath, swelling of your face, lips, eyelids, tongue, or throat, or other areas of your skin, trouble swallowing, rash, including raised, itchy red areas on your skin (hives). Swelling in the throat can be life-threatening and lead to death. Stop INGREZZA and go to nearest emergency room right away if you have signs and symptoms of allergic reactions and angioedema.
• Sleepiness and tiredness that slows reaction times. Do not drive a car/operate dangerous machinery until you know how INGREZZA affects you. Alcohol use and taking other medicines may also cause sleepiness during treatment.
• Heart rhythm problems (QT prolongation). INGREZZA may cause a heart rhythm problem called QT prolongation. Risk of QT prolongation is higher if you also take certain other medicines during treatment. Tell a healthcare provider right away if you develop any signs or symptoms, including: fast, slow, or irregular heartbeat (heart palpitations), shortness of breath, dizziness or lightheadedness, or fainting/feeling like you are going to faint.
• Neuroleptic Malignant Syndrome (NMS): NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to nearest emergency room if you have these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, irregular pulse or blood pressure, increased sweating, or very fast or uneven heartbeat.
• Parkinson-like symptoms, including: body stiffness, drooling, trouble moving or walking, trouble with balance, shaking/tremors, or falls.

Tell a healthcare provider about all your medical conditions including if you: have liver or heart problems, are/or plan to become pregnant, or are/or plan to breastfeed.

Tell a healthcare provider about all medicines you take, including that you are taking INGREZZA. Taking INGREZZA with certain other medicines may cause serious side effects. Especially tell a healthcare provider if you: take digoxin or take/have taken a monoamine oxidase inhibitor (MAOI) medicine. You should not take INGREZZA if you are taking, or have stopped taking, a MAOI within the last 14 days.

The most common side effects in people with tardive dyskinesia are sleepiness and tiredness.

The most common side effects in people with chorea associated with Huntington’s disease include sleepiness and tiredness, hives, rash, and trouble getting to sleep or staying asleep.

These are not all of the possible side effects. Call a doctor for medical advice about side effects. To report negative side effects to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For full Important Safety Information, visit INGREZZA.com.
See Prescribing Info, including Boxed Warning, at https://www.INGREZZATD.com and Med Guide at https://www.INGREZZAMGTD.com.

This video is intended for US audiences only.