- 4% of patients required dose reduction of AUSTEDO® due to adverse events vs 2% of patients taking placebo1
- Discontinuation due to adverse events occurred in 4% of patients treated with AUSTEDO® vs 3% of patients on placebo3,4
|Adverse Reaction||AUSTEDO® (n=279)||Placebo (n=131)|
|Upper respiratory tract infection||3%||4%|
|Urinary tract infection||2%||2%|
ARM-TD: C-SSRS assessments at any visit during the 12-week randomized trial2
|Patients Taking AUSTEDO® (n=58)||Patients Taking Placebo (n=59)|
|Suicidal ideation||0 (0.0%)||3 (5.2%)|
|Suicidal behavior||0 (0.0%)||1 (1.7%)|
ARM-TD: HADS for depression or anxiety—no worsening was detected at Week 12.
AIM-TD: C-SSRS assessments at any visit during the 12-week randomized trial4
|Patients Taking AUSTEDO® (n=221)||Patients Taking Placebo (n=72)|
|Suicidal ideation||7 (3.2%)||2 (2.8%)|
|Suicidal behavior||1 (0.5%)||0 (0.0%)|
AIM-TD: HADS for depression or anxiety—no worsening was detected at Week 12.
Placebo-controlled HD chorea study: adverse reactions reported in ≥4% of patients on AUSTEDO®1,2,5
|Adverse Reaction||AUSTEDO® (n=45)||Placebo (n=45)|
|Urinary tract infection||7%||2%|
- 7% of patients required dose reduction due to adverse events in both the AUSTEDO® and placebo arms1,5
- Discontinuation due to adverse events occurred in 2% of patients in both the AUSTEDO® and placebo groups1,5
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To redeem this offer, you must have a valid prescription for AUSTEDO®. No substitutions permitted. Commercially insured patients with coverage for AUSTEDO® may pay no out-of-pocket costs. Commercially insured patients whose insurer requires a prior authorization for AUSTEDO® may receive a 30 day supply of AUSTEDO® (up to a total of three prescriptions with only one prescription per AUSTEDO® strength or NDC) under the Program while their prior authorization is pending. If the prior authorization is approved by the commercial insurer, then the individual remains eligible for the Program. If the prior authorization is denied by the commercial insurer, then the individual is no longer eligible for this Program and may not receive any additional Program benefits. Maximum annual benefits apply and out-of-pocket expenses may vary. Patient is responsible for costs above maximum benefit amounts. If you have any questions regarding your eligibility or benefits, please call the AUSTEDO® Copay Program at 1-800-887-8100.
You are not eligible for this offer if your prescriptions are paid for in part or full by any state or federally funded programs, including but not limited to Medicare or Medicaid, Medigap, VA, DOD, TRICARE, or by private health benefit programs which reimburse you for the entire cost of your prescription drugs. This offer is not valid for patients who are Medicare eligible and are enrolled in an employer-sponsored health plan or prescription drug benefit program for retirees (i.e., patients who are eligible for Medicare Part D but receive a prescription drug benefit through a former employer). You are not eligible for this offer if you are uninsured or a cash-paying patient. This offer is void in California if an AB-rated generic drug is available for the product. By redeeming this offer, you acknowledge that you are an eligible patient and you understand and agree to comply with the terms and if copied, transferred, purchased, altered or traded and where prohibited and restricted by law. conditions of this offer. Void if copied, transferred, purchased, altered or traded and where prohibited and restricted by law. Program managed by PSKW, LLC on behalf of Teva Pharmaceuticals. The parties reserve the right to change or discontinue this offer at any time without notice. This offer is not health insurance.
This offer is restricted to residents of the United States and Puerto Rico and valid only at participating pharmacies. This offer is limited to one per customer and may not be used with any other discount, coupon or offer. Offer expires December 31, 2019.To the Pharmacist:
When you apply this offer, you are certifying that you have not submitted and will not submit a claim for reimbursement under any federal, state, or other governmental program for this prescription.
Pharmacist Instructions: Submit claim to Therapy First Plus. If primary coverage exists, input offer information as secondary coverage and transmit using the COB segment of the NCPDP transaction.
For questions regarding processing, please call the Help Desk 1-800-422-5604 .
AUS-41403 December 2018
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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. AUSTEDO® (deutetrabenazine) tablets current Prescribing Information. Teva Pharmaceuticals USA, Inc. 2. Data on file. Teva Neuroscience, Inc. 3. 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. 4. 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. 5. Huntington Study Group, Frank S, Testa CM, et al. Effect of deutetrabenazine on chorea among patients with Huntington disease: a randomized clinical trial. JAMA. 2016;316(1):40-50.