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Symptoms vary and are multifaceted in Huntington’s disease (HD)

  • The average length of survival after an HD diagnosis is 10 to 20 years, though some people live more than 30 years post-diagnosis1
  • The Huntington Disease Society of America (HDSA) recommends evaluating the need for anti-chorea therapy at least once a year1

HD symptoms fall into 3 main categories1:

Symptoms of Huntington's disease: Movement/Motor Symptoms (including chorea), Cognition/Thinking, Emotion/Behavior

While AUSTEDO® tablets is indicated to treat chorea associated with HD, it is not indicated to treat HD itself or other associated symptoms.

90% of people with HD will develop chorea1

HD chorea can cause significant functional impact on:

  • Fine and gross motor functions1,2
  • Gait and balance3,4
  • Ability to maintain weight5

In a survey conducted by the HDSA published in 2016, caregivers cited chorea as the most impactful symptom of HD.6

In early HD, a 1-point change in Total Motor Score, which measures overall motor symptoms, is associated with an approximately 10% loss in likelihood of being able to work, manage finances, drive, and supervise children.7,8

AUSTEDO® has not been demonstrated to affect any of these potential consequences of chorea.

Treatment goals need to consider the potential clinical consequences of chorea7

Management of chorea may be met with many challenges

Treatment options

  • There are a limited number of FDA-approved treatment options available1

Limitations of tolerability

  • Medications may have dose-limiting side effects. Treatment of chorea should be determined individually as a balance of chorea reduction and medication tolerability1

Severity of chorea

  • Chorea severity may vary over the course of the disease1,9

Prevalence of depression and suicidality in HD

  • The lifetime prevalence of major depression in people with HD is about 40%1
    • Suicide rates range from approximately 5% to 13%10
    • 25% of patients attempt suicide11

Concomitant medications

  • Some prescription medications may worsen voluntary motor control1

When treating HD chorea, the benefits should outweigh the risks

Would you like information on AUSTEDO® for treatment of TD in adults and chorea associated with HD?

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Indications and Usage

AUSTEDO® is indicated for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia in adults.

Important Safety Information

Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO® 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, suicidality, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidality 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. AUSTEDO® is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.

Contraindications: AUSTEDO® is contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO® is also contraindicated in: patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine (Xenazine®) or valbenazine (Ingrezza®).

Clinical Worsening and Adverse Events in Patients with Huntington’s Disease: AUSTEDO® may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO® in their patients by assessing the effect on chorea and possible adverse effects.

QTc Prolongation: Tetrabenazine, a closely related VMAT2 inhibitor, causes an increase in the corrected QT (QTc) interval. A clinically relevant QT prolongation may occur in some patients treated with AUSTEDO® who are CYP2D6 poor metabolizers or are co-administered a strong CYP2D6 inhibitor. Dose reduction may be necessary. The use of AUSTEDO® in combination with other drugs known to prolong QTc may result in clinically significant QT prolongations. For patients requiring AUSTEDO® doses greater than 24 mg per day who are using AUSTEDO® with other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of AUSTEDO® or the other drugs. AUSTEDO® should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias.

Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex reported in association with drugs that reduce dopaminergic transmission, has been observed in patients receiving tetrabenazine. The risk may be increased by concomitant use of dopamine antagonists or antipsychotics. The management of NMS should include immediate discontinuation of AUSTEDO®; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.

Akathisia, Agitation, and Restlessness: AUSTEDO® may increase the risk of akathisia, agitation, and restlessness. The risk of akathisia may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops akathisia, the AUSTEDO® dose should be reduced; some patients may require discontinuation of therapy.

Parkinsonism: AUSTEDO® may cause parkinsonism in patients with Huntington’s disease or tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. The risk of parkinsonism may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops parkinsonism, the AUSTEDO® dose should be reduced; some patients may require discontinuation of therapy.

Sedation and Somnolence: Sedation is a common dose-limiting adverse reaction of AUSTEDO®. Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, until they are on a maintenance dose of AUSTEDO® and know how the drug affects them. Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence.

Hyperprolactinemia: Tetrabenazine elevates serum prolactin concentrations in humans. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO®.

Binding to Melanin-Containing Tissues: Deutetrabenazine or its metabolites bind to melanin-containing tissues and could accumulate in these tissues over time. Prescribers should be aware of the possibility of long-term ophthalmologic effects.

CYP2D6 Metabolism: In patients who are poor CYP2D6 metabolizers or are taking strong CYP2D6 inhibitors, the total daily dosage of AUSTEDO® should not exceed 36 mg (maximum single dose of 18 mg).

Common Adverse Reactions: The most common adverse reactions for AUSTEDO® (>8% and greater than placebo) in a controlled clinical study in patients with Huntington’s disease were somnolence, diarrhea, dry mouth, and fatigue. The most common adverse reactions for AUSTEDO® (4% and greater than placebo) in controlled clinical studies in patients with tardive dyskinesia were nasopharyngitis and insomnia.

Please see accompanying full Prescribing Information, including Boxed Warning.

References: 1. Nance M, Paulsen JS, Rosenblatt A, Wheelock V. A Physician’s Guide to the Management of Huntington’s Disease. 3rd ed. Huntington’s Disease Society of America (HDSA) website. http://hdsa.org/wp-content/uploads/2015/03/PhysiciansGuide_3rd-Edition.pdf. Published 2011. Accessed February 27, 2018. 2. Phillips JG, Bradshaw L, Chiu E, Bradshaw JA. Characteristics of handwriting of patients with Huntington’s disease. Mov Disord. 1994;9(5):521-530. 3. Grimbergen YAM, Knol MJ, Bloem BR, Kremer BPH, Roos RAC, Munneke M. Falls and gait disturbances in Huntington’s disease. Mov Disord. 2008;23(7):970-976. 4. Burgunder JM, Guttman M, Perlman S, Goodman N, van Kammen DP, Goodman L. An international survey-based algorithm for the pharmacologic treatment of chorea in Huntington’s disease. PLoS Curr. 2011;3:RRN1260. 5. Hamilton JM, Wolfson T, Peavy GM, Jacobson MW, Corey-Bloom J; Huntington Study Group. Rate and correlates of weight change in Huntington’s disease. J Neurol Neurosurg Psychiatry. 2004;75(2):209-212. 6. Simpson JA, Lovecky D, Kogan J, Vetter LA, Yohrling GJ. Survey of the Huntington’s disease patient and caregiver community reveals most impactful symptoms and treatment needs. J Huntingtons Dis. 2016;5(4):395-403. 7. Armstrong MJ, Miyasaki JM; American Academy of Neurology. Evidence-based guideline: pharmacologic treatment of chorea in Huntington’s disease: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2012;79(6):597-603. 8. Beglinger LJ, O’Rourke JJ, Wang C, Langbehn DR, Duff K, Paulsen JS; Huntington Study Group Investigators. Earliest functional declines in Huntington disease. Psychiatry Res. 2010;178(2):414-418. 9. Ross CA, Tabrizi SJ. Huntington’s disease: from molecular pathogenesis to clinical treatment. Lancet Neurol. 2011;10(1):83-98. 10. Wetzel HH, Gehl CR, Dellefave-Castillo L, Schiffman JF, Shannon KM, Paulsen JS; Huntington Study Group. Suicidal ideation in Huntington disease: the role of comorbidity. Psychiatry Res. 2011;188(3):372-376. 11. Killoran A, Biglan KM. Current therapeutic options for Huntington’s disease: good clinical practice versus evidence-based approaches? Mov Disord. 2014;29(11):1404-1413.