Voiceover/Onscreen text:

INDICATIONS AND USAGE

AUSTEDO® XR (deutetrabenazine) extended-release tablets and AUSTEDO® (deutetrabenazine) tablets are indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia.

IMPORTANT SAFETY INFORMATION

Depression and Suicidality in Patients with Huntington’s Disease:

AUSTEDO XR and 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 XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.

Please see additional Important Safety Information at the end of this video.

Rajeev Kumar:

Hello. I’m Dr. Rajeev Kumar, Medical Director of the Rocky Mountain Movement Disorders Center and Huntington’s Disease Society of America Center of Excellence in Colorado. For over 20 years, I have been working with patients to treat their chorea symptoms.

I was involved in the evaluation of AUSTEDO in the pivotal trial for treatment of chorea associated with HD. I chose to be involved because the success of this trial could lead to a treatment for my patients with chorea.

I had a conversation with a colleague the other day about our patients with HD chorea. AUSTEDO is an appropriate choice to treat those symptoms, and I thought it’d be insightful to share some of our discussion with you.

My colleague said he was concerned about the impact chorea symptoms were having on his patients and their caregivers. He was particularly concerned about patients who were not aware of their symptoms and had become increasingly reliant on their caregivers. Even when patients are not aware of their symptoms, it is still important to treat them because of the impact chorea can have on their ability to function and their need for daily assistance.

The efficacy and safety of AUSTEDO were demonstrated in a randomized, 12-week placebo-controlled study in patients with chorea. The primary endpoint was total maximal chorea, or TMC, score. AUSTEDO reduced TMC score by 4.4 points from baseline, more than twice the improvement in the TMC score from placebo. The reduction in chorea was demonstrated in the face, mouth, trunk, and legs.

In my experience, after patients begin treatment, they often acknowledge improvements in areas of self-care and activities of daily living. My colleague and I talked about how we have observed improvement in our patients first-hand—particularly in areas of daily living, including walking, bathing, dressing, lifting, carrying groceries, moderate to vigorous activities, or climbing stairs.

Both patients and clinicians reported treatment success as measured by the Patient Global Impression of Change, or PGIC, and Clinical Global Impression of Change, or CGIC. Treatment is considered successful when symptoms are rated as “much improved” or “very much improved.” On the PGIC, the patient success rate with AUSTEDO was 51 percent, compared with 20 percent for placebo.

The physical function portion of the Short-Form 36 Health Survey, known as the SF-36, supported these findings as well. In the clinical trial for AUSTEDO, there was a statistically significant reduction in disability and improvement in physical functioning compared with placebo at 12 weeks.

While we were talking about study results, I mentioned that I tell my patients the most common side effects can include drowsiness, dry mouth, diarrhea, and fatigue. And I encourage them to share with me any symptoms they find bothersome.

Disclaimer at bottom of screen:

Patients who participated in the clinical trials discussed in this testimonial received the BID formulation of AUSTEDO.

Rajeev Kumar:

In my practice, I have been pleased with the experience my patients with HD chorea have had with AUSTEDO, particularly with their improvements in areas of daily living, physical functioning, and reduced disability. In addition to managing symptoms, I am always looking for opportunities to offer my patients a choice. With the availability of AUSTEDO XR, my patients have the option to take their treatment once daily.

Voiceover/Onscreen text:

INDICATIONS AND USAGE

AUSTEDO® XR (deutetrabenazine) extended-release tablets and AUSTEDO® (deutetrabenazine) are indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia.

IMPORTANT SAFETY INFORMATION

Depression and Suicidality in Patients with Huntington’s Disease:

AUSTEDO XR and 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 XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.

Contraindications: AUSTEDO XR and AUSTEDO are contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO XR and AUSTEDO are 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 or valbenazine.

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

QTc Prolongation: AUSTEDO XR and AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO XR or AUSTEDO is administered within the recommended dosage range. AUSTEDO XR and 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 XR and AUSTEDO; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.

Akathisia, Agitation, and Restlessness: AUSTEDO XR and 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 XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.

Parkinsonism: AUSTEDO XR and 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 XR or 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 XR and 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 XR or 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 XR and 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.

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. Adverse reactions with AUSTEDO XR extended-release tablets are expected to be similar to AUSTEDO tablets.

Please see full Prescribing Information, including Boxed Warning, at AUSTEDOhcp.com.

Voiceover/Onscreen text:

INDICATIONS AND USAGE

AUSTEDO® XR (deutetrabenazine) extended-release tablets and AUSTEDO® (deutetrabenazine) tablets are indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia.

IMPORTANT SAFETY INFORMATION Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO XR and 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 XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.

Please see additional Important Safety Information at the end of this video.

Fahd Amjad:

Hello. I am Dr. Fahd Amjad, Co-Director of the Huntington’s Disease Care, Education, Research Center at Georgetown University Medical Center in Washington, DC.

For over 10 years, I have led our mission to provide treatment to and manage the symptoms experienced by patients with Huntington’s disease, or HD.

I ran into a colleague the other day, and thought I would share the conversation we had about our patients with HD chorea. More than 90 percent of patients with HD have chorea, and as neurologists, we appreciate the challenges faced by patients with chorea symptoms.

We both regularly observe that patients with chorea have difficulty walking and may fall. My colleague recently started managing a new patient with chorea symptoms and wanted to understand what my goals are for patients. Because patients with chorea are at risk of falls, they often become dependent on their partners or caregivers for help with their daily activities. One of my goals is to help patients maintain their independence for as long as possible.

I asked my colleague what he prescribes for his patients with chorea. Both of us consider AUSTEDO, a vesicular monoamine transporter 2 inhibitor, or VMAT2, for the management of chorea symptoms in patients with HD.

I choose AUSTEDO because its efficacy and safety were demonstrated in a randomized, 12-week, placebo-controlled study in patients with chorea associated with HD. The results showed a statistically significant reduction in chorea of the face, mouth, trunk, arms, and legs as measured by the total maximal chorea score.

AUSTEDO is also the first VMAT2 inhibitor to have physicians and patients rate overall HD chorea symptoms as “much improved” or “very much improved” when compared to placebo as measured by the Clinical Global Impression of Change and Patient Global Impressions of Change scales.

I mentioned to him that I recently reviewed a 3-year open-label extension study called ARC-HD, published in CNS Drugs. This AUSTEDO study interests me as a provider because HD is a progressive condition, and the study demonstrated about 3 years of continued control of chorea in patients.

Disclaimer at bottom of page:

Patients who participated in the clinical trials discussed in this testimonial received the BID formulation for AUSTEDO.

Fahd Amjad:

I am also confident in the demonstrated safety profile of AUSTEDO and explain to my patients that the most common side effects include somnolence, diarrhea, dry mouth, and fatigue. These side effects occur most often during the dosing titration phase.

Most of my patients are on an average daily of 36 mg with some up to 48 mg, which aligns with the clinical trials for AUSTEDO. And I can also offer my patients more options with the introduction of AUSTEDO XR, a once-daily formulation.

Voiceover/Onscreen text:

INDICATIONS AND USAGE

AUSTEDO® XR (deutetrabenazine) extended-release tablets and AUSTEDO® (deutetrabenazine) tablets are indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia.

IMPORTANT SAFETY INFORMATION Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO XR and 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 XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.

Contraindications: AUSTEDO XR and AUSTEDO are contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO XR and AUSTEDO are 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 or valbenazine.

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

QTc Prolongation: AUSTEDO XR and AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO XR or AUSTEDO is administered within the recommended dosage range. AUSTEDO XR and 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 XR and AUSTEDO; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.

Akathisia, Agitation, and Restlessness: AUSTEDO XR and 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 XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.

Parkinsonism: AUSTEDO XR and 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 XR or 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 XR and 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 XR or 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 XR and 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.

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. Adverse reactions with AUSTEDO XR extended-release tablets are expected to be similar to AUSTEDO tablets.

Please see full Prescribing Information, including Boxed Warning, at AUSTEDOhcp.com.