Drugs Q & A

How Effective is Ingrezza (Valbenazine)

Ingrezza is a brand-name prescription drug approved by the Food and Drug Administration (FDA) in April 2017. It’s the first drug approved for the treatment of tardive dyskinesia TD. It contains the active ingredient Valbenazine and is used to treat  (TD) in adults.

Tardive dyskinesia is an uncommon side effect of certain medicines. People who develop this drug-induced movement disorder can’t control their facial movements. They develop facial tics like lip-smacking, tongue thrusting, and rapid blinking. It may occur due to drugs, or antipsychotics, that treat mental illness.

Tardive dyskinesia affects more than 500,000 Americans. An estimated 1 in 4 people who take antipsychotic (neuroleptic) medications for many years develop this problem.

How is Ingrezza taken?

Ingrezza comes as capsules that are taken by mouth once each day. It’s available in two strengths: 40 mg and 80 mg. It is usually taken with or without food once a day. Take valbenazine at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take valbenazine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of valbenazine and may increase your dose once one week later. Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

How Ingrezza works

Ingrezza belongs to a class of medications called vesicular monoamine transporter 2 (VMAT2) inhibitors. It works to treat TD symptoms by decreasing the abnormal functioning of dopamine (a chemical in the brain that helps control movement). This abnormal functioning is thought to be the cause of TD symptoms.

Ingrezza is thought to reduce extra dopamine signaling while working directly in the region of the brain that causes uncontrollable movements of tardive dyskinesia (TD).

How Effective is Ingrezza

Data from clinical trials indicate that Ingrezza was effective at reducing TD symptoms. After 6 weeks of treatment, 40% of people taking 80 mg of Ingrezza daily had at least a 50% decrease in their TD symptoms. In comparison, 8.7% of people taking a placebo (treatment with no active drug) had the same result.

In these same studies, after 48 weeks of treatment, about 52% of people taking 80 mg of Ingrezza daily had at least a 50% decrease in their TD symptoms. In comparison, about 28% of people taking 40 mg of Ingrezza daily had the same result.

Will I see continued results with Ingrezza?

In a clinical study, people on Ingrezza started to see improvements in their tardive dyskinesia (TD) movements at 2 weeks and continued to see reductions in uncontrollable body movements throughout the duration of the 48-week trial.

How do I know Ingrezza is working?

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.

 What are the common side effects of Ingrezza?

In a clinical study, the most common side effect was sleepiness.

Other serious side effects were heart rhythm problems and abnormal movements, including shaking, body stiffness, trouble moving or walking, or keeping your balance. Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you faint.

Other side effects include:

o       Changes in balance (balance problems, dizziness) or increased risk of falls

o       Blurred vision

o       Constipation

o       Dry mouth

o       Feelings of restlessness

o       Headache

These are not all of the possible side effects of Ingrezza. Call your healthcare provider 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.

Are there savings programs available for Ingrezza?

Yes—the INBRACE® Support Program could help you save on your Ingrezza prescription. You may pay as little as a $0 copay on your Ingrezza prescription with the Ingrezza Savings Program. If you are eligible, a Savings Card may be applied automatically, which may help you save money on your Ingrezza prescription.*

•        According to the manufacturer, this offer is valid only for patients who have commercial (nongovernment-funded) insurance. Additional terms and conditions apply.

 How do I get Ingrezza?

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.

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