AustedoView the results of AUSTEDO clinical trials in patients with TD or patients with chorea associated with HD.
Mechanism of action and PK profile
VMAT2 inhibition can help regulate dopamine function1
Some vesicular monoamine transporter 2 (VMAT2) inhibitors reduce available dopamine via alpha and/or beta metabolites that block sequestration in the presynaptic vesicle.2
- Unsequestered dopamine is degraded by monoamine oxidase3
- Reducing dopamine levels in the presynaptic neuron results in less dopamine signaling to the postsynaptic neuron, leading to fewer abnormal involuntary movements1
The precise mechanism by which AUSTEDO (deutetrabenazine) tablets exerts its effects in the treatment of tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD) is unknown, but it is believed to be related to its effect as a reversible depletor of monoamines (such as dopamine, serotonin, norepinephrine, and histamine) from nerve terminals.2
- The major circulating active metabolites (alpha-dihydrotetrabenazine [HTBZ] and beta-HTBZ) of deutetrabenazine are reversible inhibitors of VMAT2, resulting in decreased uptake of monoamines into presynaptic vesicles and depletion of monoamine stores
- VMAT2 is inhibited through both the alpha and beta metabolites to provide potent inhibition
See how the VMAT2 inhibition of AUSTEDO reduces dopamine levels
A differentiated PK profile
AUSTEDO features deuterium, extending the half-life of active therapeutic metabolites to 9-10 hours2,6
- Pharmacokinetic (PK) simulations of area under the curve (AUC)-matched exposure to active metabolites based on dosing regimens of AUSTEDO (9 mg twice daily) and tetrabenazine (12.5 mg 3 times a day) at steady state.7
Plasma Concentrations of Alpha and Beta Metabolites Over 24 Hours—PK Model7
Slower rate of rise, lower peak-to-trough fluctuations, and reduced Cmax may allow for reduced interpatient metabolic variability.6,7
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AUSTEDO® (deutetrabenazine) tablets Copay Program Terms and Conditions
Terms, Conditions and Eligibility Requirements
To the Patient:
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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References: 1. 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. doi:10.2147/DDDT.S133205 2. AUSTEDO® (deutetrabenazine) tablets current Prescribing Information Parsippany, NJ. Teva Neuroscience, Inc. 3. Blakely RD, Edwards RH. Vesicular and plasma membrane transporters for neurotransmitters. Cold Spring Harb Perspect Biol. 2012;4(2):a005595. doi:10.1101/cshperspect.a005595 4. Zai CC, Tiwari AK, Mazzoco M, et al. Association study of the vesicular monoamine transporter gene SLC18A2 with tardive dyskinesia. J Psychiatr Res. 2013;47(11):1760-1765. Published online September 6, 2013. doi:10.1016/j.jpsychires.2013.07.025 5. Aquino CC, Lang AE. Tardive dyskinesia syndromes: current concepts. Parkinsonism Relat Disord. 2014;20(suppl 1):S113-117. doi: 10.1016/S1353-8020(13)70028-2 6. Tung R. The development of deuterium-containing drugs. Innovations in Pharmaceutical Technology. 2010;32(32):24-28. 7. Data on file. Parsippany, NJ: Teva Neuroscience, Inc.