Brand Name

Ingrezza

Generic Name
Valbenazine
View Brand Information
FDA approval date: October 04, 2017
Classification: Vesicular Monoamine Transporter 2 Inhibitor
Form: Kit, Capsule

What is Ingrezza (Valbenazine)?

Living with tardive dyskinesia (TD) can be an incredibly challenging and isolating experience. The uncontrollable, repetitive movements of the face, tongue, trunk or limbs are not just physical, they can profoundly impact self-esteem, social interactions, and overall quality of life. For many years, these movements, often a side effect of necessary medications for mental health, had no approved treatment. The introduction of Ingrezza (valbenazine) marked a turning point, offering the first FDA-approved medication specifically designed to manage this condition.

Ingrezza is a newer, specialized prescription medication that belongs to a class of drugs called vesicular monoamine transporter 2 (VMAT2) inhibitors. It is not a medication for the underlying mental health condition, but a targeted therapy focused solely on reducing the involuntary movements of TD. For patients and their loved ones, understanding how Ingrezza works provides hope and a clear path toward regaining control and confidence.

What does Ingrezza do?

Ingrezza is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with tardive dyskinesia. TD is characterized by involuntary movements that can include:

  • Lip smacking, puckering or pursing
  • Grimacing or frowning
  • Rapid eye blinking
  • Tongue protrusion
  • Involuntary movements of the arms, legs, fingers or toes

Ingrezza aims to reduce the severity and frequency of unwanted movements, offering significant relief to improve speaking, eating, and social engagement, though it is not a cure.

Clinical studies have shown Ingrezza to be effective for many patients. In these trials, individuals taking Ingrezza experienced a significant reduction in their involuntary movements compared to those taking a placebo, with many noticing improvements within a few weeks of starting treatment (Neurocrine Biosciences, Inc., 2023).

How does Ingrezza work?

To understand how Ingrezza works, it helps to know a little about a key chemical messenger in the brain called dopamine. Dopamine is a neurotransmitter that plays a vital role in coordinating movement. Tardive dyskinesia is believed to occur when long-term use of certain medications (like antipsychotics) causes the dopamine receptors in the brain to become overly sensitive. This leads to an excess of dopamine signaling, which is like having the “volume” turned up too high in the part of the brain that controls movement, resulting in the involuntary muscle activity of TD.

Ingrezza works by targeting a protein in the brain called VMAT2. Think of VMAT2 as a transporter responsible for packaging dopamine into storage containers (vesicles) within nerve cells before it can be released. Ingrezza is a VMAT2 inhibitor, which means it partially blocks this transporter.

By gently “putting the brakes” on VMAT2, Ingrezza reduces the amount of dopamine that gets loaded into these storage containers. As a result, less dopamine is released from the nerve cells. This helps to turn down the “volume” of the overactive dopamine signals, which calms the excessive nerve activity and leads to a reduction in the involuntary movements of TD. This is a highly selective mechanism designed to rebalance the movement control system in the brain without interfering with the medications used to treat the underlying psychiatric condition.

Ingrezza side effects

Like any medication, Ingrezza has potential side effects. The most common ones are generally mild, but it’s important to discuss any concerns with your healthcare provider.

The most common side effect of Ingrezza is sleepiness or drowsiness (somnolence). Other common side effects may include:

  • Changes in balance or coordination
  • Dry mouth
  • Constipation
  • Blurred vision
  • Dizziness

QT prolongation, a change in heart rhythm, is a less common but important side effect. Your doctor will assess its safety if you have a pre-existing heart condition.

Ingrezza can cause parkinsonism-like symptoms (tremors, stiffness, trouble moving); report these to your doctor. Do not drive or operate machinery until you know its effects. Seek immediate medical help for allergic reactions (hives, facial/tongue swelling, breathing issues) (Mayo Clinic, 2024).

Ingrezza dosage

Ingrezza is a once-daily oral capsule, taken with or without food. Doctors typically begin with a lower dose for the first week, then increase to the therapeutic dose. This gradual approach minimizes side effects as the body adjusts.

Ingrezza typically doesn’t require routine blood tests. However, your doctor will monitor your tardive dyskinesia symptoms and inquire about side effects, especially sleepiness. For patients with specific heart conditions, an ECG may be recommended to monitor heart rhythm.

Inform your doctor of all medications, as some may interact with Ingrezza. Liver problems (moderate to severe) may require dose adjustments.

Does Ingrezza have a generic version?

No, Ingrezza (valbenazine) is a brand-name medication and there is no generic version currently available in the United States. However, international versions may exist in other markets. As a newer drug, it is protected by patents that prevent other companies from manufacturing a generic equivalent. When these patents expire in the future, the FDA may approve generic versions, which could provide more affordable options.

Conclusion

For many years, living with tardive dyskinesia meant living without an approved treatment. Ingrezza has fundamentally changed that reality, offering a targeted, effective way to manage the involuntary movements that can be so disruptive to a person’s life. By precisely regulating dopamine activity in the brain, it helps to restore balance and reduce symptoms, often leading to a significant improvement in confidence and well-being.

While it has potential side effects, its safety profile is well-established, and risks can be managed with close medical supervision. If you or a loved one is affected by TD, having a conversation with a healthcare provider about Ingrezza is an empowering step toward taking control of the condition and improving your quality of life.

References

  1. Mayo Clinic. (2024). Valbenazine (Oral Route). Retrieved from https://www.mayoclinic.org/drugs-supplements/valbenazine-oral-route/side-effects/drg-20406212
  2. Neurocrine Biosciences, Inc. (2023). INGREZZA® (valbenazine) capsules Prescribing Information. U.S. Food and Drug Administration. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209241s014lbl.pdf
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Brand Information

INGREZZA (Valbenazine)
WARNING: DEPRESSION AND SUICIDAL IDEATION AND BEHAVIOR IN PATIENTS WITH HUNTINGTON’S DISEASE
VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease. Anyone considering the use of INGREZZA or INGREZZA SPRINKLE must balance the risks of depression and suicidal ideation and behavior with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidal ideation and behavior and instruct them to report behaviors of concern promptly to the treating physician.
Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in patients with Huntington’s disease
1INDICATIONS AND USAGE
INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with:
- tardive dyskinesia
- chorea associated with Huntington’s disease
2DOSAGE FORMS AND STRENGTHS
INGREZZA
  • 40 mg capsule: white opaque body and purple cap, printed with ‘VBZ’ and ‘40’ in black ink. Each capsule contains 40 mg valbenazine.
  • 60 mg capsule: dark red opaque body and purple cap, printed with ‘VBZ’ and ‘60’ in black ink. Each capsule contains 60 mg valbenazine.
  • 80 mg capsule: purple opaque body and cap, printed with ‘VBZ’ and ‘80’ in black ink. Each capsule contains 80 mg valbenazine.
INGREZZA SPRINKLE
  • 40 mg capsule: pearl white opaque cap and body, printed with a band, directional arrows, and “VBZ 40” in black ink on both the cap and body. Each capsule contains 40 mg valbenazine.
  • 60 mg capsule: pearl white opaque cap and body, printed with a band, directional arrows, and “VBZ 60” in dark red ink on both the cap and body. Each capsule contains 60 mg valbenazine.
  • 80 mg capsule: pearl white opaque cap and body, printed with a band, directional arrows, and “VBZ 80” in purple ink on both the cap and body. Each capsule contains 80 mg valbenazine.
3CONTRAINDICATIONS
INGREZZA and INGREZZA SPRINKLE are contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA or INGREZZA SPRINKLE. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported with use of INGREZZA
4ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in more detail in other sections of the labeling:
  • Depression and Suicidal Ideation and Behavior in Patients with Huntington’s Disease
  • Hypersensitivity Reactions
  • Somnolence and Sedation
  • QT Prolongation
  • Neuroleptic Malignant Syndrome (NMS)
  • Parkinsonism
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of INGREZZA SPRINKLE has been established from adequate and well-controlled studies of INGREZZA
Tardive Dyskinesia
Variable and Fixed Dose Placebo-Controlled Trial Experience
The safety of INGREZZA was evaluated in 3 placebo-controlled studies, each 6 weeks in duration (fixed dose, dose escalation, dose reduction), including 445 patients. Patients were 26 to 84 years of age with moderate to severe tardive dyskinesia and had concurrent diagnoses of mood disorder (27%) or schizophrenia/ schizoaffective disorder (72%). The mean age was 56 years. Patients were 57% Caucasian, 39% African-American, and 4% other. With respect to ethnicity, 28% were Hispanic or Latino. All subjects continued previous stable regimens of antipsychotics; 85% and 27% of subjects, respectively, were taking atypical and typical antipsychotic medications at study entry.  
Adverse Reactions Leading to Discontinuation of Treatment
A total of 3% of INGREZZA-treated patients and 2% of placebo-treated patients discontinued because of adverse reactions.
Common Adverse Reactions
Adverse reactions that occurred in the 3 placebo-controlled studies at an incidence of ≥2% and greater than placebo are presented in
1 Within each adverse reaction category, the observed adverse reactions are listed in order of decreasing frequency.
Other Adverse Reactions Observed During the Premarketing Evaluation of INGREZZA
Other adverse reactions of ≥1% incidence and greater than placebo are shown below. The following list does not include adverse reactions: 1) already listed in previous tables or elsewhere in the labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, 4) which were not considered to have clinically significant implications, or 5) which occurred at a rate equal to or less than placebo.
Endocrine Disorders: blood glucose increased
General Disorders: weight increased
Infectious Disorders: respiratory infections
Neurologic Disorders: drooling, dyskinesia, extrapyramidal symptoms (non-akathisia)
Psychiatric Disorders: anxiety, insomnia
During the tardive dyskinesia controlled trials, there was a dose-related increase in prolactin. Additionally, in these trials there was a dose-related increase in alkaline phosphatase and bilirubin, suggesting a potential risk for cholestasis.
Chorea Associated with Huntington’s Disease
The safety of INGREZZA was evaluated in a 14-week placebo-controlled study including 127 patients with chorea associated with Huntington’s disease. Patients were 25 to 75 years of age. The mean age was 54 years. Patients were 96% Caucasian, 1% African-American, 1% Asian, and 2% Other. With respect to ethnicity, 6% were Hispanic or Latino. 
Adverse Reactions Leading to Discontinuation of Treatment
A total of 8% of INGREZZA-treated patients and 6% of placebo-treated patients discontinued because of adverse reactions.
Common Adverse Reactions
Adverse reactions that occurred in the placebo-controlled study at an incidence of ≥4% and greater than placebo are presented in
4.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of INGREZZA that are not included in other sections of labeling. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: hypersensitivity reactions (including allergic dermatitis and pruritis) 
5OVERDOSAGE
Human Experience
The pre-marketing clinical trials involving INGREZZA in approximately 850 subjects do not provide information regarding symptoms with overdose.  
Management of Overdosage
No specific antidotes for INGREZZA or INGREZZA SPRINKLE are known. In managing overdose, provide supportive care, including close medical supervision and monitoring, and consider the possibility of multiple drug involvement. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
6DESCRIPTION
INGREZZA and INGREZZA SPRINKLE contains valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, present as valbenazine tosylate salt, with the chemical name, L-Valine, (
INGREZZA contains valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, present as valbenazine tosylate salt, with the chemical name, L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester, 4-methylbenzenesulfonate (1:2).  Valbenazine tosylate is slightly soluble in water.  Its molecular formula is C38H54N2O10S2, and its molecular weight is 762.97 g/mol (ditosylate salt) with the following structure:
The molecular formula of valbenazine free base is C
INGREZZA is intended for oral administration only. Each capsule contains 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The capsules contain the following inactive ingredients: hypromellose, isomalt, magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose. The capsule shells contain candurin silver fine, FD&C Blue#1, FD&C Red#40, and gelatin.
INGREZZA SPRINKLE is intended for oral administration. Each capsule contains granules consisting of 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The oral granules contain the following inactive ingredients: silicified microcrystalline cellulose, isomalt, pregelatinized maize starch, hypromellose, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc in hard gelatin capsules (contains gelatin and candurin silver fine).
7HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
INGREZZA (valbenazine) capsules are available as:
40 mg Capsule: White opaque body with a purple cap, printed with ‘VBZ’ and ‘40’ in black ink.
60 mg Capsule:  Dark red opaque body with a purple cap, printed with ‘VBZ’ and ‘60’ in black ink.
80 mg Capsule: Purple opaque body and cap, printed with ‘VBZ’ and ‘80’ in black ink.
INGREZZA SPRINKLE (valbenazine) capsules are available as:
40 mg Capsule: Pearl white opaque cap and body, printed with a band, directional arrows, and “VBZ 40” in black ink on both the cap and body.
60 mg Capsule: Pearl white opaque cap and body, printed with a band, directional arrows, and “VBZ 60” in dark red ink on both the cap and body.
80 mg Capsule: Pearl white opaque cap and body, printed with a band, directional arrows, and “VBZ 80” in purple ink on both the cap and body.
Table 6:       INGREZZA and INGREZZA SPRINKLE Configurations and NDC Numbers
Storage
INGREZZA: Store at 15°C to 30°C (59°F to 86°F).
INGREZZA SPRINKLE: Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture. Dispense in original container or in a tight container as defined in USP.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
Depression and Suicidal Ideation and Behavior in Patients with Huntington’s Disease
Inform patients, their caregivers, and families of the risks of depression, worsening depression, and suicidal ideation and behavior associated with INGREZZA and INGREZZA SPRINKLE, and instruct them to report behaviors of concern promptly to the treating physician. Patients with Huntington’s disease who express suicidal ideation should be evaluated immediately
Hypersensitivity Reactions
Inform patients about the signs and symptoms of hypersensitivity reactions, such as angioedema, including difficulty breathing, swelling of the face, lips, eyelids, tongue or throat. Advise patients to discontinue INGREZZA or INGREZZA SPRINKLE immediately if any of these reactions occur and report to the emergency room if symptoms of angioedema occur
Somnolence and Sedation
Inform patients that INGREZZA and INGREZZA SPRINKLE may cause somnolence and may impair the ability to perform tasks that require complex motor and mental skills. Advise patients that until they learn how they respond to INGREZZA or INGREZZA SPRINKLE, they should be careful or avoid doing activities that require them to be alert, such as driving a car or operating machinery
Prolongation of the QT Interval
Inform patients to consult their physician immediately if they feel faint, lose consciousness, or have heart palpitations
Neuroleptic Malignant Syndrome (NMS)
Counsel patients about a potentially fatal adverse reaction – neuroleptic malignant syndrome (NMS) – that has been reported in association with administration of VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE. Advise patients to contact a healthcare provider or report to the emergency room if they experience signs or symptoms of NMS
Parkinsonism
Inform patients that parkinson-like symptoms may occur while taking INGREZZA or INGREZZA SPRINKLE. Advise patients to consult their healthcare provider if they experience difficulty moving or loss of ability to move muscles voluntarily, tremor, gait disturbances, or drooling
Pregnancy
Advise a pregnant patient of the potential risk to a fetus
Lactation
Advise a woman not to breastfeed during treatment with INGREZZA or INGREZZA SPRINKLE and for 5 days after the final dose
Administration Information for INGREZZA SPRINKLE
Advise patients to read and follow the Instructions for Use for INGREZZA SPRINKLE.
Advise the patient of the following:
  • INGREZZA SPRINKLE may be opened and the entire contents of the capsule sprinkled over a bowl containing a small amount (1 tablespoonful) of soft food such as applesauce, yogurt, or pudding. Stir the contents of the capsule into the soft food.
  • INGREZZA SPRINKLE may also be swallowed whole with water
For further information on INGREZZA or INGREZZA SPRINKLE, call 84-INGREZZA (844-647-3992).
Distributed by:
Neurocrine Biosciences, Inc.
INGREZZA is a registered trademark of Neurocrine Biosciences, Inc.
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