Dosing & Getting Started

Flexibility for effective & tolerable control¹

Graphic representing dosing up to 48 mg/day with once pill, once-daily AUSTEDO XR. Patients reach 30 mg/day with Titration Kit at the end of Week 4. Most patients were between 36 mg/day and 48 mg/day at the end of the long-term study.

See dosing schedule

Patients in the pivotal and long-term studies received the AUSTEDO BID formulation.^1,2

Image shown is not actual 4-week Titration Kit. Tablets not shown at actual size.

*52% of patients at Week 145.²

Start patients at no cost with the easy-to-use Titration Kit³

Sample with Titration Kit
+ prescribe 36 mg/day for Week 5

AUSTEDO XR 4 Week Titration Kit and 36-mg Rx.

Ask your Sales Rep for samples. Notify
pharmacy if patient has been sampled.

Prescribe Retail Titration Kit
with 30-day Free Trial Voucher applied^†
+ prescribe 36 mg/day for Week 5

AUSTEDO XR 4 Week Titration Kit and 30-day Free Trial Voucher for new patients.

Pharmacy will dispense prescribed Kit
and apply 30-day Free Trial Voucher.

Titration Kit NDC: 68546-0477-29

Continue titrating weekly until symptom control is effectively and tolerably achieved (48 mg/day maximum dosage).¹

^†Certain restrictions apply. Terms and conditions on AUSTEDOcardform.com.

Physicians reported treatment success starting patients on the 4-week Titration
Kit^3‡

Additional dosing and administration information¹

Billing codes

Specialty Pharmacy Quick Reference Guide

A comprehensive guide for getting patients started on one pill, once-daily AUSTEDO XR.

Additional resources to help with patient access:

Download the Appeals Letter Template

Download the Letter of Medical Necessity Template

Request a rep

REFERENCES: 1. AUSTEDO^® XR (deutetrabenazine) extended-release tablets and AUSTEDO^® current Prescribing Information. Parsippany, NJ: Teva Neuroscience, Inc. 2. 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. 3. Data on file. Parsippany, NJ: Teva Neuroscience, Inc. 4. Anderson KE, Konings M, Finkbeiner S, et al. Treatment patterns, effectiveness, and satisfaction with deutetrabenazine in Huntington Disease when initiated using a 4-week patient titration kit: interim results of the START Study. Presented at: Huntington Study Group^® (HSG) Annual Meeting; November 2-4, 2023; Phoenix, AZ.

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.

Flexibility for effective & tolerable control¹

Start patients at no cost with the easy-to-use Titration Kit³

Sample with Titration Kit
+ prescribe 36 mg/day for Week 5

Prescribe Retail Titration Kit
with 30-day Free Trial Voucher applied^†
+ prescribe 36 mg/day for Week 5

In the real-world START study of the
4-week Titration Kit^3§:

Patients & physicians reported³:

Flexibility for effective & tolerable control1

Start patients at no cost with the easy-to-use Titration Kit3

Sample with Titration Kit+ prescribe 36 mg/day for Week 5

Prescribe Retail Titration Kitwith 30-day Free Trial Voucher applied† + prescribe 36 mg/day for Week 5

In the real-world START study of the 4-week Titration Kit3§:

Patients & physicians reported3:

Flexibility for effective & tolerable control¹

Start patients at no cost with the easy-to-use Titration Kit³

Sample with Titration Kit
+ prescribe 36 mg/day for Week 5

Prescribe Retail Titration Kit
with 30-day Free Trial Voucher applied^†
+ prescribe 36 mg/day for Week 5

In the real-world START study of the
4-week Titration Kit^3§:

Patients & physicians reported³: