Frequently asked questions about INGREZZA

INGREZZA is an FDA-approved treatment proven to reduce TD that’s always one capsule, once daily, and #1 prescribed.

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.

INGREZZA is also FDA approved for the treatment of adults with Huntington’s disease (HD) chorea. 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.

Tardive dyskinesia (TD) is persistent, uncontrolled body movements. TD movements can occur anywhere in the body:

• Face (mouth, lips, tongue, jaw, eyes)

• Upper body (arms, torso)

• Hands/fingers

• Legs

• Feet/toes

You may have been prescribed certain mental health medicines (antipsychotics) to treat a condition such as:

• Depression

• Bipolar disorder

• Schizophrenia

• Schizoaffective disorder

Certain prescription medicines (metoclopramide and prochlorperazine) used to treat gastrointestinal disorders may also cause TD.

Current research suggests that INGREZZA helps by correcting abnormal dopamine signaling; however, how INGREZZA works to treat TD is not fully understood.

• Dopamine is a chemical in the brain that helps control movement

• TD may be caused by too much dopamine signaling in the brain

• INGREZZA is believed to reduce extra dopamine signaling

INGREZZA is used to treat adults with TD in the face, tongue, and other body parts. Adults with mild, moderate, and severe uncontrollable movements of TD should talk to their healthcare provider about INGREZZA.

INGREZZA is clinically proven for reducing TD in adults at 6 weeks.^* Most people saw a response as early as 2 weeks.^†

^*In a 6-week clinical trial, based on average change from baseline to Week 6 on the Abnormal Involuntary Movement Scale (AIMS). Results for INGREZZA 80 mg –3.2 (n=79) vs placebo –0.1 (n=76).

^†Individual results may vary. At Week 2, 52% (41/79) of people taking INGREZZA 80 mg had a 2-point or greater reduction on AIMS in the 6-week clinical trial.

In a clinical study, psychiatric status remained stable overall in people taking INGREZZA for TD, including those who were also taking medicine for:

• Depression

• Bipolar disorder

• Schizophrenia

• Schizoaffective disorder

People taking INGREZZA for TD can stay on their current dose of most mental health medicines.

INGREZZA continued to show TD improvement with continued use. In a long-term study, more than half of people taking INGREZZA saw no or minimal movements for each body part after 48 weeks of treatment with INGREZZA.*

*In a post-clinical study evaluation of the KINECT 4 trial, 59% (61/103) of people who completed the trial taking INGREZZA (40 mg and 80 mg) achieved a score of 1 or less for each body part measured with AIMS at Week 48. The results are descriptive in nature.

Ask your healthcare provider to explain how INGREZZA works, when to expect results, and to clarify the goals of your treatment, including what you should look for to know if it’s working.

The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with tardive dyskinesia are sleepiness and tiredness.

These are not all of the possible side effects of INGREZZA or INGREZZA SPRINKLE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.

INGREZZA makes dosing simple from the start:

• Starts at an effective dose

• Also available in sprinkle formulation

• Always one capsule, once daily

• Taken any time

• With or without food

• Can be added to most stable mental health regimens

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. If you take too much INGREZZA, call your poison control center at 1-800-222-1222.

If you have trouble swallowing, or prefer not to swallow pills whole, ask your healthcare provider about INGREZZA SPRINKLE.

It works the same as INGREZZA but is available in an easy-to-open capsule with oral granules you can simply sprinkle over soft food such as applesauce, yogurt, or pudding, followed by a glass of water.

See the Instructions for Use for important information on how to take INGREZZA SPRINKLE.

Yes. The Neurocrine Access Support Program could help you save on your INGREZZA prescription.

Commercially insured patients may pay as little as $0.* If you're eligible, a Savings Card may be applied automatically at the pharmacy, which may help you save on your INGREZZA prescription.*

*Additional terms and conditions apply.

Call or email your healthcare provider (if it’s an option) and ask them to repeat any information you didn’t understand at your appointment or to explain it differently—they may not realize they might be using confusing, scientific terms.

Also, consider including a family member, care partner, or friend to join you at your next appointment. They can help you better understand and remember your healthcare provider’s advice and instructions.

There’s an entire community of support. Below are organizations that can help. Click any of the logos to learn more.

Whether your uncontrollable body movements are mild, moderate, or severe, connecting with a psychiatry or neurology healthcare provider who may be able to help you diagnose and treat tardive dyskinesia (TD) is important.

When your prescription is authorized, you’ll receive calls from the specialty pharmacy to verify your important information. The pharmacy will call to verify your information each time your prescription needs to be refilled.

(Note: These calls may come from an unidentified toll-free number, so it’s important to answer your phone.)

If your healthcare provider sent your prescription to a specialty pharmacy, INGREZZA will be shipped directly to you via overnight mail. A specialty pharmacy provides medicines that aren’t typically available at your local retail pharmacy. In some cases, your healthcare provider may send your prescription to a local select pharmacy. INGREZZA is distributed through select specialty and local affiliated pharmacies.

Yes—resources are available to help you start and stay on track with treatment.

You are NOT required to change therapy at your insurance company’s request, even if you received a letter from them requesting that you try a different therapy than INGREZZA.

The most important thing you can do is talk to your doctor and share your experience taking INGREZZA. You can also call 1-84-INGREZZA (1-844-647-3992), 8 AM to 8 PM ET, Monday through Friday, for additional assistance.

Are you or a loved one taking INGREZZA to treat tardive dyskinesia (TD)? Do you have an interest in sharing your story? If you’re a US resident and 18 years or older, please call 1-800-256-5290 to find out if you are eligible to participate in our INGREZZA Ambassador Program. Any information you provide will be kept in accordance with our privacy policy.

Please note that not all candidates will be selected to participate in the program.

Yes—resources are available to help you take care of your loved one who has TD.