For adults with TD or HD chorea¹

Make a move that matters With ONE PILL, ONCE-DAILY AUSTEDO XR

Significant response at Week 12 in pivotal
studies.
Increasing improvement observed
over
3 years in open-label extension study^3-5*^†

only with austedo xr

Flexibility for effective and tolerable control, including for patients taking medications metabolized by CYP3A4/5 or CYP2D6, or
P-gp substrates^1,2,6

only with austedo xr

Patients can start AUSTEDO XR for free with the 4-week Titration Kit⁶

*Patients in the pivotal and long-term studies received the AUSTEDO BID formulation.^1,5

^†71% of patients at Week 145 saw improvement relative to Week 15.⁶

Mechanism of Action:

VMAT2 inhibition can help regulate dopamine function.⁷

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Voiceover:

Maintaining a balance in the level of dopamine is essential for controlled movement.

Dopamine signaling is facilitated by vesicular monoamine transporter 2, or VMAT2, which transports monoamines, including dopamine, from the cytosol into synaptic vesicles, keeping them ready for subsequent release in response to an action potential.

When an action potential reaches the nerve terminal of the presynaptic neuron, dopamine is released from the synaptic vesicles into the synaptic cleft.

This dopamine binds to receptors on the postsynaptic neuron, thereby signaling movement.

Excess dopamine signaling manifests as abnormal involuntary movements.

AUSTEDO^® (deutetrabenazine) is a VMAT2 inhibitor.

Deutetrabenazine contains deuterium, a naturally occurring heavy version of hydrogen. Deuterium forms stronger molecular bonds with carbon atoms, thereby extending the half-life of therapeutic metabolites.

The precise mechanism by which deutetrabenazine exerts its effects on abnormal involuntary movements is unknown. It is believed to be related to its effect as a reversible depleter of monoamines, including dopamine, from nerve terminals.

Deutetrabenazine binds to VMAT2 on the vesicle in the presynaptic neuron and inhibits the uptake of dopamine into synaptic vesicles.

Dopamine molecules collect outside the blocked VMAT2 and are degraded by monoamine oxidase.

Reducing dopamine levels in the presynaptic neuron results in less dopamine signaling to the postsynaptic neuron.

Limiting dopamine signaling is believed to lead to fewer abnormal involuntary movements.

HD, Huntington’s disease; TD, tardive dyskinesia; VMAT2, vesicular monoamine transporter 2.

REFERENCES: 1. AUSTEDO XR^® (deutetrabenazine) extended-release tablets and AUSTEDO^® current Prescribing Information. Parsippany, NJ: Teva Neuroscience, Inc. 2. Ingrezza^® (valbenazine) capsules. Prescribing Information. San Diego, CA: Neurocrine Biosciences, Inc. 3. Anderson KE, Stamler D, Davis MD, et al. Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Psychiatry. 2017;4(8):595-604. 4. Fernandez HH, Factor SA, Hauser RA, et al. Randomized controlled trial of deutetrabenazine for tardive dyskinesia: the ARM-TD study. Neurology. 2017;88(21):2003-2010. 5. Hauser RA, Barkay H, Fernandez HH, et al. Long-term deutetrabenazine treatment for tardive dyskinesia is associated with sustained benefits and safety: a 3-year, open-label extension study. Front Neurol. 2022;13:773999. 6. Data on file. Parsippany, NJ: Teva Neuroscience, Inc. 7. Solmi M, Pigato G, Kane JM, Correll CU. Treatment of tardive dyskinesia with VMAT-2 inhibitors: a systematic review and meta-analysis of randomized controlled trials. Drug Des Devel Ther. 2018;12:1215-1238.

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.

Make a move that matters With ONE PILL, ONCE-DAILY AUSTEDO XR

Significant response at Week 12 in pivotal studies. Increasing improvement observed over 3 years in open-label extension study3-5*†

Flexibility for effective and tolerable control, including for patients taking medications metabolized by CYP3A4/5 or CYP2D6, or P-gp substrates1,2,6

Mechanism of Action:

Significant response at Week 12 in pivotal
studies.
Increasing improvement observed
over
3 years in open-label extension study^3-5*^†

Flexibility for effective and tolerable control, including for patients taking medications metabolized by CYP3A4/5 or CYP2D6, or
P-gp substrates^1,2,6