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Once-daily INGREZZA® (valbenazine) capsules

Tardive dyskinesia impact and prevalence

Disruptive, distressing, stigmatizing—tardive dyskinesia (TD) has been shown to be an added burden for patients already managing an underlying mental illness1,2,a,b

Disruptivea,b

Uncontrolled movements can impact patients’ ability to perform daily activities1,2

Distressinga,b

Abnormal and uncontrolled movements may cause embarrassment in public1-3

Stigmatizinga,b

TD symptoms may exacerbate the stigma associated with existing mental illness1-4

a

Includes results based on a survey of patients diagnosed with TD (n=127), who were asked, “How would you rate your current ability to undertake your regular activities?” Responses based on a 3-point scale selection of “Low,” “Medium,” or “High”; “What would you say about your general well-being in each of the following areas?” Responses based on 7-point Likert scale (range of 1 [“Not good at all”] to 7 [“Excellent”]); “Tardive dyskinesia may impact you in different ways. To what extent has tardive dyskinesia impacted you in each of the following areas?” Responses based on 7-point Likert scale (range of 1 [“Not at all impacted”] to 7 [“Extremely impacted”]).1
b

Includes results based on a survey of psychiatric patients with a clinician-confirmed diagnosis of TD or absence of TD. Health-related quality of life was assessed by: SF-12 Health Survey, Version 2 (SF-12v2), Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF), Social Withdrawal subscale of the Internalized Stigma of Mental Illness Scale (SW-ISMI), and 2 questions on movement disorders.2

Between 7.2% and 30% of patients on antipsychotics had tardive dyskinesia according to a 2017 meta-analysis of 41 studies5:

30%

of patients on first-generation antipsychotics

20.7%

of patients on second-generation antipsychotics (with unspecified first-generation antipsychotic use)

7.2%

of patients on second-generation antipsychotics with no prior history of first-generation antipsychotics

While anyone with exposure to antipsychotics can develop TD,5 the following may be associated with increased risk:

Patient risk factors for TD

  • Aged 50 or older6
  • Substance use disorder7
  • Being postmenopausal8
  • Diagnosis of mood disorder9

Treatment risk factors for TD

  • Cumulative exposure to antipsychotics7
  • Treatment with anticholinergics7
  • History of acute extrapyramidal symptoms7
  • Potency of antipsychotics10
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Take the TD Challenge:
Overview and impact

What causes TD? What are the risk factors for TD?
How may TD impact your patients?
Put your knowledge to the test.

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Take the TD Challenge:
Overview and impact

Question 1 of 5

TD Challenge

Take the TD Challenge: Overview and impact

Question 1 of 5

TRUE OR FALSE:

Tardive dyskinesia (TD) is a clinically distinct, drug-induced movement disorder and is associated with prolonged exposure to dopamine receptor blocking agents (DRBAs), including antipsychotics.

TRUE FALSE

THE CORRECT RESPONSE IS TRUE.

Tardive dyskinesia is distinct from acute extrapyramidal symptoms, such as drug-induced parkinsonism.1,2

Prolonged exposure to DRBAs, including antipsychotics, is believed to cause hypersensitivity in postsynaptic dopamine D2 receptors, one of the areas of the brain that controls motor function.3,4

ASSESSMENT TIP

TD doesn’t just present in the face and mouth—involuntary movements may impact upper and lower limbs, the neck, and trunk. A comprehensive full body assessment can help you identify involuntary movements.5,6

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QUESTION

Take the TD Challenge:
Overview and impact

Question 2 of 5

TD Challenge

Take the TD Challenge:
Overview and impact

Question 2 of 5

TRUE OR FALSE:

In a 2017 web-based survey, >50% of all patients diagnosed with tardive dyskinesia (TD), regardless of disease severity, reported that they experienced emotional, social, and psychological impact.

TRUE FALSE

THE CORRECT RESPONSE IS TRUE.

All severities of tardive dyskinesia can negatively impact a patient’s well-being, not just severe TD.1

In a 2017 survey, >50% of patients with TDa who self-identified as mild to severe (n=127) reported that TD had a meaningful emotional, social, and psychological impact.1,b,c

ASSESSMENT TIP

The involuntary and uncontrollable movements from tardive dyskinesia may not only impact your patients physically, but also emotionally.1

When assessing the signs of tardive dyskinesia, ask about how it is affecting their everyday lives.

NEXT
QUESTION

Impact of TD: Patient survey results1,b,c

>50%

of patients with mild to severe TD (n=127) reported emotional, social, and psychological impact1,a,b,c

61%

reported emotional impact
(n=127)

31% Mild TDc (n=26) 62% Moderate TDc (n=68) 82% Severe TDc (n=33)

62%

reported social impact
(n=127)

35% 65% 79% Mild TDc (n=26) Moderate TDc (n=68) Severe TDc (n=33)

52%

reported psychological impact
(n=127)

19% 56% 70% Mild TDc (n=26) Moderate TDc (n=68) Severe TDc (n=33)
a

Self-reported as diagnosed by a physician.
b

Question from research: Tardive dyskinesia may impact you in many different ways. To what extent has tardive dyskinesia impacted you in each of the following areas?

Responses were based on a 7-point Likert scale (ranged 1 [“Not at all impacted”] to 7 [“Extremely impacted”]). Results shown include responses of ≥6.
c

Patients self-identified as having mild, moderate, or severe TD.

Patient survey design1

The blinded online survey was completed by patients between April 26 and November 20, 2017. There were 2 versions of the survey:

  • Sample A, for antipsychotic patients (n=2419)
  • Sample B, for TD-diagnosed patients (n=127) and symptomatic, undiagnosed patients (n=44)

Screening criteria1

Sample A (n=2419)
  • 18 years or older
  • Diagnosed with psychiatric or gastrointestinal disorder requiring treatment with a DRBA
  • Have taken a DRBA within the past 2 years
  • Not diagnosed with TD

 

Sample B (n=171)
  • Currently taking a DRBA or have taken a DRBA in the past 12 months
  • Self-reported as diagnosed with TD by a physician (with the exception of the symptomatic, undiagnosed patients)
  • Experienced TD symptoms (involuntary, repetitive movements) after initiation of DRBA therapy

Take the TD Challenge:
Overview and impact

Question 3 of 5

TD Challenge

Take the TD Challenge:
Overview and impact

Question 3 of 5

TRUE OR FALSE:

Prolonged exposure to any antipsychotic, whether first or second generation, is a definitive risk factor for tardive dyskinesia (TD).

TRUE FALSE

THE CORRECT RESPONSE IS TRUE.

Despite common misconceptions, prolonged use of second-generation antipsychotics is still associated with TD.

In fact, between 7.2% and 30% of patients on antipsychotics had tardive dyskinesia according to a 2017 meta-analysis of 41 studies.1

ASSESSMENT TIP

All patients exposed to antipsychotic medication should be monitored for signs of tardive dyskinesia at every clinical encounter—not just those taking first-generation antipsychotics.2

NEXT
QUESTION
NEXT
QUESTION

A 2017 meta-analysis of 41 studiesa found TD in patients receiving first-generation and/or second-generation antipsychotics1

of patients on second-generation antipsychotics (with unspecified first-generation antipsychotic use) had TD of patients on second-generation antipsychotics with no prior history of first-generation antipsychotic use had TD 30% 20.7% 7.2% of patients on first-generation antipsychotics had TD of patients on second-generation antipsychotics (with unspecified first-generation antipsychotic use) had TD of patients on second-generation antipsychotics with no prior history of first-generation antipsychotic use had TD 30% 20.7% 7.2% of patients on first-generation antipsychotics had TD
a

A 2017 meta-analysis was conducted using 41 full-text studies that reported on TD prevalence by drug class. Articles were published from 2000 to 2015 (to exclude earlier studies during the era of high-dose first-generation antipsychotic use). To meet the inclusion criteria, the studies were required to provide cross-sectional data from ≥15 patients treated with first-generation and/or second-generation antipsychotics to avoid the inclusion of case series, and to use a standardized rating scale to evaluate TD. The majority of studies (87.8%) used the Abnormal Involuntary Movement Scale (AIMS). Other scales included the Extrapyramidal Symptom Rating Scale, the Involuntary Movement Scale, and the dyskinesia subscale of the Matson Evaluation of Drug Side Effects.

Take the TD Challenge:
Overview and impact

Question 4 of 5

TD Challenge

Take the TD Challenge:
Overview and impact

Question 4 of 5

TRUE OR FALSE:

Tardive dyskinesia (TD) will not persist following withdrawal of antipsychotics.

TRUE FALSE

THE CORRECT RESPONSE IS FALSE.

TD may persist, and even worsen, despite reduction in dose or discontinuation of antipsychotics.1

According to the 2013 American Academy of Neurology guidelines, there is a lack of clear evidence to support or refute withdrawing or switching antipsychotics to treat TD. And changing a patient’s antipsychotic regimen may destabilize the underlying psychiatric condition.2

ASSESSMENT TIP

While anyone with exposure to antipsychotics can develop tardive dyskinesia, the following may be associated with increased risk: aged 50 and older, substance abuse, being postmenopausal, diagnosis of mood disorder, history of acute extrapyramidal symptoms (EPS), and potency of antipsychotics.3-8

NEXT
QUESTION

Take the TD Challenge:
Overview and impact

Question 5 of 5

TD Challenge

Take the TD Challenge:
Overview and impact

Question 5 of 5

SCREENING

The American Psychiatric Association (APA) recommends that all patients taking antipsychotics be monitored for tardive dyskinesia (TD) every…

VISIT 3–12 MONTHS 12–24 MONTHS

THE CORRECT RESPONSE IS EVERY VISIT.

Regularly monitoring and screening for TD is important to identify movements, minimize worsening, and institute clinically indicated treatment.1

The 2020 APA guidelines state that the clinical assessment of antipsychotic-induced movement disorders, including TD, should be conducted at baseline (prior to starting or changing antipsychotic treatment) and at every follow-up visit for all patients taking antipsychotics, regardless of their risk.1

For patients with the presence of any abnormal movements, the guidelines recommend assessment with a structured instrument, such as the AIMS or DISCUS, at baseline and at a minimum of every 6 months in high-risk patients, and every 12 months in other patients.1

AIMS, Abnormal Involuntary Movement Scale; DISCUS, Dyskinesia Identification System Condensed User Scale.

ASSESSMENT TIP

When screening for TD, be sure to look for: history and current use of DRBAs (including first- and second-generation antipsychotics); choreiform (rapid and jerky) movements of the eyes, lips, jaw, tongue, and limbs; and athetoid (slow, sinuous, or writhing) movements of the hands, feet, and trunk.2-4

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SCORE
X/X correct

You’ve completed the TD Challenge:
Overview and impact

RECOGNIZE AND SCREEN FOR TD

Get familiar with the phenomenology of tardive dyskinesia and how to differentiate TD movements from other drug-induced movement disorders

TD MOVEMENTS

HELP YOUR TD PATIENTS TAKE CONTROL11

Explore how INGREZZA reduced TD severity in both short- and long-term studies of adult patients with TD

REVIEW EFFICACY

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Register for INGREZZA Insider for access to case study videos showing results of INGREZZA in real-world TD patients treated in real-world clinical settings

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EXPERT PERSPECTIVES:

The impact and importance of regular screening

Watch as Dr. Andrew Cutler discusses the challenges of TD and the importance of regular screening.

Impact of TD video

EXPERT PERSPECTIVES:

The impact and importance of regular screening

Watch as Dr. Andrew Cutler discusses the challenges of TD and the importance of regular screening.

REFERENCES:

  1. Data on file. Neurocrine Biosciences, Inc
  2. McEvoy J, Gandhi SK, Rizio AA, et al. Effect of tardive dyskinesia on quality of life in patients with bipolar disorder, major depressive disorder, and schizophrenia. Qual Life Res. 2019;28(12):3303-3312
  3. Task Force on Tardive Dyskinesia. Tardive Dyskinesia: A Task Force Report of the American Psychiatric Association. Washington, DC: American Psychiatric Association; 1992
  4. Boumans CE, de Mooij KJ, Koch PA, van ’t Hof MA, Zitman FG. Is the social acceptability of psychiatric patients decreased by orofacial dyskinesia?. Schizophr Bull. 1994;20(2):339-344
  5. Carbon M, Hsieh C-H, Kane JM, Correll CU. Tardive dyskinesia prevalence in the period of second-generation antipsychotic use: a meta-analysis. J Clin Psychiatry. 2017;78(3):e264-e278
  6. Woerner MG, Alvir JM, Saltz BL, Lieberman JA, Kane JM. Prospective study of tardive dyskinesia in the elderly: rates and risk factors. Am J Psychiatry. 1998;155(11):1521-1528
  7. Miller DD, McEvoy JP, Davis SM, et al. Clinical correlates of tardive dyskinesia in schizophrenia: baseline data from the CATIE schizophrenia trial. Schizophr Res. 2005;80(1):33-43
  8. Turrone P, Seeman MV, Silvestri S. Estrogen receptor activation and tardive dyskinesia. Can J Psychiatry. 2000;45(3):288-290
  9. Casey DE. Affective disorders and tardive dyskinesia. Encephale. 1988;14(spec):221-226
  10. Divac N, Prostran M, Jakovcevski I, Cerovac N. Second-generation antipsychotics and extrapyramidal adverse effects. Biomed Res Int. 2014;2014:656370
  11. INGREZZA [package insert]. San Diego, CA: Neurocrine Biosciences, Inc

Important Information

INDICATION & USAGE

INGREZZA® (valbenazine) capsules is indicated for the treatment of adults with tardive dyskinesia.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

INGREZZA is contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported.

WARNINGS & PRECAUTIONS

Somnolence

INGREZZA can cause somnolence. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA.

QT Prolongation

INGREZZA may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.

Parkinsonism

INGREZZA may cause parkinsonism in patients with tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. Reduce the dose or discontinue INGREZZA treatment in patients who develop clinically significant parkinson-like signs or symptoms.

ADVERSE REACTIONS

The most common adverse reaction (≥5% and twice the rate of placebo) is somnolence. Other adverse reactions (≥2% and >Placebo) include: anticholinergic effects, balance disorders/falls, headache, akathisia, vomiting, nausea, and arthralgia.

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.

Please see INGREZZA full Prescribing Information

Indication and Important Safety Information

INGREZZA is contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA.

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Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported.

INDICATION & USAGE

INGREZZA® (valbenazine) capsules is indicated for the treatment of adults with tardive dyskinesia.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

INGREZZA is contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported.

Important Information

INDICATION & USAGE

INGREZZA® (valbenazine) capsules is indicated for the treatment of adults with tardive dyskinesia.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

INGREZZA is contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported.

WARNINGS & PRECAUTIONS

Somnolence

INGREZZA can cause somnolence. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA.

QT Prolongation

INGREZZA may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.

Parkinsonism

INGREZZA may cause parkinsonism in patients with tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. Reduce the dose or discontinue INGREZZA treatment in patients who develop clinically significant parkinson-like signs or symptoms.

ADVERSE REACTIONS

The most common adverse reaction (≥5% and twice the rate of placebo) is somnolence. Other adverse reactions (≥2% and >Placebo) include: anticholinergic effects, balance disorders/falls, headache, akathisia, vomiting, nausea, and arthralgia.

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.

Please see INGREZZA full Prescribing Information

EXPAND FOR
GUIDELINES

INGREZZA is a recommended first-line TD treatment option.

See guidelines and recommendations
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