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INGREZZA® (valbenazine) capsules

Tardive dyskinesia treatment guidelines
and recommendations

Treat first line with INGREZZA

Experts agree that VMAT2 inhibitors, like INGREZZA® (valbenazine) capsules, are the preferred first-line treatment for tardive dyskinesia (TD)1-3

2020 American Psychiatric Association guidelines1

  • Treatment with a VMAT2 inhibitor is recommended in patients with moderate to severe TD and may also be considered in patients with mild TD

Systematic review of new evidence since 2013 American Academy of Neurology guidelines2

  • New generation VMAT2 inhibitors should be recommended as first-line treatment for TD

2020 Delphi Panel consensus recommendations3

  • Treatment of TD with a VMAT2 inhibitor should be considered as part of a comprehensive treatment plan

Actor portrayal

INGREZZA is recommended as a first-line treatment option for adults with tardive dyskinesia (TD)1-3

TD TREATMENT CONSIDERATIONS

Preserve antipsychotic regimens

INGREZZA capsules offers the ability to treat TD while preserving your patient’s antipsychotic regimen4

2013 American Academy of Neurology guidelines5

  • There is a lack of clear evidence to support or refute withdrawing or switching antipsychotics to treat TD
  • Changing a patient’s antipsychotic regimen may destabilize the underlying psychiatric condition

2020 American Psychiatric Association guidelines1

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

Is it time to think differently about tardive dyskinesia (TD) treatment?

TD is distinct from other drug-induced movement disorders and requires unique treatment.6 Anticholinergics do not reduce and could even increase the risk for TD, despite widespread use for prophylaxis and treatment of acute drug-induced movement disorders, like parkinsonism.7,8

2020 American Psychiatric Association guidelines1

  • Anticholinergic medications do not improve and may even worsen TD

2020 Delphi Panel consensus recommendations3

  • As part of TD management, providers should consider modifying anticholinergic agents (eg, reduce dose, taper off)

2013 American Academy of Neurology guidelines5

  • There are insufficient data to recommend anticholinergics for the treatment of TD

Watch expert perspective videos on screening and managing TD

Featuring Bryce Reynolds, MD

These videos were sponsored and developed by Neurocrine Biosciences.
The speaker is a paid consultant of Neurocrine Biosciences.

Changing mindsets for tardive dyskinesia (TD) assessments

Changing mindsets for tardive dyskinesia assessments, video

Changing mindsets for tardive dyskinesia (TD) assessments

Using motivational interviewing to talk about tardive dyskinesia (TD) and treatment

Using motivational interviewing to talk about tardive dyskinesia and treatment, video

Using motivational interviewing to talk about tardive dyskinesia (TD) and treatment

DIFFERENTIATE TD MOVEMENTS

Differentiate the signs of tardive dyskinesia from acute drug-induced movement disorders—learn more

DIFFERENTIATE TD

THERAPEUTIC DOSE FROM DAY 1

The only VMAT2 inhibitor that offers an effective starting dosage you can adjust based on response and tolerability1

DOSING INFO

REFERENCES:

  1. Keepers GA, Fochtmann LJ, Anzia JM, et al. The American Psychiatric Association Practice Guideline for the Treatment of Patients With Schizophrenia. 3rd ed. American Psychiatric Association Publishing, 2020.
  2. Bhidayasiri R, Jitkritsadakul O, Friedman JH, Fahn S. Updating the recommendations for treatment of tardive syndromes: a systematic review of new evidence and practical treatment algorithm. J Neurol Sci. 2018;389:67-75.
  3. Caroff SN, Citrome L, Meyer J, et al. A modified Delphi consensus study of the screening, diagnosis, and treatment of tardive dyskinesia. J Clin Psychiatry. 2020;81(2):19cs12983.
  4. INGREZZA [package insert]. San Diego, CA: Neurocrine Biosciences, Inc.
  5. Summary of evidence-based guidelines for clinicians: treatment of tardive syndromes. American Academy of Neurology website. https://www.aan.com/Guidelines/Home/GetGuidelineContent/613. Published 2013. Accessed August 22, 2018.
  6. Ward KM, Citrome L. Antipsychotic-related movement disorders: drug-induced parkinsonism vs. tardive dyskinesia—key differences in pathophysiology and clinical management. Neurol Ther. 2018;7(2):233-248.
  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. Desmarais JE, Beauclair L, Margolese HC. Anticholinergics in the era of atypical antipsychotics: short-term or long-term treatment? J Psychopharmacol. 2012;26(9):1167-1174.
  9. Glazer WM, Morgenstern H, Schooler N, Berkman CS, Moore DC. Predictors of improvement in tardive dyskinesia following discontinuation of neuroleptic medication. Br J Psychiatry. 1990;157:585-592.
  10. Caroff SN, Hurford I, Lybrand J, Campbell EC. Movement disorders induced by antipsychotic drugs: implications of the CATIE schizophrenia trial. Neurol Clin 2011;29(1):127-viii.

Important Information

INDICATION & USAGE

INGREZZA® (valbenazine) capsules and INGREZZA® SPRINKLE (valbenazine) capsules are indicated in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease.

IMPORTANT SAFETY INFORMATION

Depression and Suicidality in Patients with Huntington’s Disease: VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality 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. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in patients with Huntington’s disease.

CONTRAINDICATIONS

INGREZZA and INGREZZA SPRINKLE are contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA or INGREZZA SPRINKLE.

WARNINGS & PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions, including cases of angioedema involving the larynx, glottis, lips, and eyelids, have been reported in patients after taking the first or subsequent doses of INGREZZA. Angioedema associated with laryngeal edema can be fatal. If any of these reactions occur, discontinue INGREZZA or INGREZZA SPRINKLE.

Somnolence and Sedation

INGREZZA and INGREZZA SPRINKLE can cause somnolence and sedation. 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 or INGREZZA SPRINKLE.

QT Prolongation

INGREZZA and INGREZZA SPRINKLE may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA and INGREZZA SPRINKLE 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.

Neuroleptic Malignant Syndrome

A potentially fatal symptom complex referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with drugs that reduce dopaminergic transmission, including INGREZZA. The management of NMS should include immediate discontinuation of INGREZZA or INGREZZA SPRINKLE, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems. If treatment with INGREZZA or INGREZZA SPRINKLE is needed after recovery from NMS, patients should be monitored for signs of recurrence.

Parkinsonism

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

ADVERSE REACTIONS

The most common adverse reaction in patients with tardive dyskinesia (≥5% and twice the rate of placebo) is somnolence.

The most common adverse reactions in patients with chorea associated with Huntington’s disease (≥5% and twice the rate of placebo) are somnolence/lethargy/sedation, urticaria, rash, and insomnia.

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.

Dosage Forms and Strengths: INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules.

Please see full Prescribing Information, including Boxed Warning.

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Important Safety Information

Depression and Suicidality in Patients with Huntington’s Disease: VMAT2 inhibitors, including INGREZZA, can increase the risk of depression and suicidal thoughts and

Important Information

INDICATION & USAGE

INGREZZA® (valbenazine) capsules and INGREZZA® SPRINKLE (valbenazine) capsules are indicated in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease.

IMPORTANT SAFETY INFORMATION

Depression and Suicidality in Patients with Huntington’s Disease: VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality 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. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in patients with Huntington’s disease.

Important Information

INDICATION & USAGE

INGREZZA® (valbenazine) capsules and INGREZZA® SPRINKLE (valbenazine) capsules are indicated in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease.

IMPORTANT SAFETY INFORMATION

Depression and Suicidality in Patients with Huntington’s Disease: VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality 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. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in patients with Huntington’s disease.

CONTRAINDICATIONS

INGREZZA and INGREZZA SPRINKLE are contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA or INGREZZA SPRINKLE.

WARNINGS & PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions, including cases of angioedema involving the larynx, glottis, lips, and eyelids, have been reported in patients after taking the first or subsequent doses of INGREZZA. Angioedema associated with laryngeal edema can be fatal. If any of these reactions occur, discontinue INGREZZA or INGREZZA SPRINKLE.

Somnolence and Sedation

INGREZZA and INGREZZA SPRINKLE can cause somnolence and sedation. 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 or INGREZZA SPRINKLE.

QT Prolongation

INGREZZA and INGREZZA SPRINKLE may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA and INGREZZA SPRINKLE 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.

Neuroleptic Malignant Syndrome

A potentially fatal symptom complex referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with drugs that reduce dopaminergic transmission, including INGREZZA. The management of NMS should include immediate discontinuation of INGREZZA or INGREZZA SPRINKLE, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems. If treatment with INGREZZA or INGREZZA SPRINKLE is needed after recovery from NMS, patients should be monitored for signs of recurrence.

Parkinsonism

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

ADVERSE REACTIONS

The most common adverse reaction in patients with tardive dyskinesia (≥5% and twice the rate of placebo) is somnolence.

The most common adverse reactions in patients with chorea associated with Huntington’s disease (≥5% and twice the rate of placebo) are somnolence/lethargy/sedation, urticaria, rash, and insomnia.

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.

Dosage Forms and Strengths: INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules.

Please see full Prescribing Information, including Boxed Warning.

Considerations for appropriate tardive dyskinesia treatment

Stopping antipsychotics completely resolved tardive dyskinesia symptoms for only

2% of patients

Based on a prospective study of 49 TD patients examined monthly for up to 59 months after antipsychotic discontinuation.

ACCORDING TO A REVIEW OF LONG-TERM AND ANTIPSYCHOTIC DISCONTINUATION STUDIES:

98% of patients continued to experience uncontrolled movements9

Based on a prospective study of 49 TD patients examined monthly for up to 59 months after antipsychotic discontinuation.

33%–53% may experience temporary worsening of TD with withdrawal dyskinesia or unmasking10

Based on drug discontinuation studies, in which the clinical course of TD was systematically followed.

36%–55% may eventually improve over time10

Based on drug discontinuation studies, in which the clinical course of TD was systematically followed for ≥1 year after drug discontinuation.

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