Tardive Dyskinesia

Chorea

<section class="Section" data-sectioncode="34089-3"><a name="LINK_cb765023-86e1-4ea5-81dc-1deb3571d425"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>AUSTEDO XR extended-release tablets and AUSTEDO tablets are formulated with deutetrabenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor for oral administration. The molecular weight of deutetrabenazine is 323.46; the pKa is 6.31. Deutetrabenazine is a hexahydro-dimethoxybenzoquinolizine derivative and has the following chemical name: (RR, SS)-1, 3, 4, 6, 7, 11b-hexahydro-9, 10-di(methoxy-d3)-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-one.The molecular formula for deutetrabenazine is C19H21D6NO3. Deutetrabenazine is a racemic mixture containing the following structures:<div class="Figure"><img alt="chemical-structure.jpg" src="image-1.jpg"/></div>Deutetrabenazine is a white to slightly yellow crystalline powder that is sparingly soluble in water and soluble in ethanol. AUSTEDO XRAUSTEDO XR extended-release tablets contain 6 mg, 12 mg, 18 mg, 24 mg, 30 mg, 36 mg, 42 mg, or 48 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, cellulose acetate, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, magnesium stearate, polyethylene glycol, polyethylene glycol 3350, polyethylene oxide, polyvinyl alcohol, propylene glycol, shellac, sodium chloride, talc, titanium dioxide, and FD&amp;C red #40 lake. The 6 mg, 12 mg, 18 mg, 30 mg, 36 mg, and 42 mg extended-release tablets also contain FD&amp;C yellow #6 lake. The 6 mg, 12 mg, 24 mg, and 36 mg extended-release tablets also contain FD&amp;C blue #2 lake. The 18 mg extended-release tablets also contain carmine. AUSTEDO XR Delivery System Components and Performance AUSTEDO XR uses osmotic pressure to deliver deutetrabenazine at a controlled rate. The delivery system, which resembles a round tablet in appearance, consists of a bilayer core tablet that contains deutetrabenazine along with other excipients. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool.AUSTEDOAUSTEDO tablets contain 6 mg, 9 mg, or 12 mg deutetrabenazine, and the following inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, polysorbate 80, polyvinyl alcohol, povidone, propylene glycol, shellac, talc, titanium dioxide, and FD&amp;C blue #2 lake. The 6 mg tablets also contain FD&amp;C red #40 lake. The 12 mg tablets also contain FD&amp;C yellow #6 lake.</section>

Austedo

deutetrabenazine

deutetrabenazine 12 MG Oral Tablet

deutetrabenazine 12 MG Oral Tablet [Austedo]

deutetrabenazine 6 MG Oral Tablet

deutetrabenazine 6 MG Oral Tablet [Austedo]

deutetrabenazine 9 MG Oral Tablet

deutetrabenazine 9 MG Oral Tablet [Austedo]

24 HR deutetrabenazine 12 MG Extended Release Oral Tablet

24 HR deutetrabenazine 12 MG Extended Release Oral Tablet [Austedo]

24 HR deutetrabenazine 24 MG Extended Release Oral Tablet

24 HR deutetrabenazine 24 MG Extended Release Oral Tablet [Austedo]

24 HR deutetrabenazine 6 MG Extended Release Oral Tablet

24 HR deutetrabenazine 6 MG Extended Release Oral Tablet [Austedo]

24 HR deutetrabenazine 30 MG Extended Release Oral Tablet

24 HR deutetrabenazine 30 MG Extended Release Oral Tablet [Austedo]

24 HR deutetrabenazine 36 MG Extended Release Oral Tablet

24 HR deutetrabenazine 36 MG Extended Release Oral Tablet [Austedo]

24 HR deutetrabenazine 42 MG Extended Release Oral Tablet

24 HR deutetrabenazine 42 MG Extended Release Oral Tablet [Austedo]

24 HR deutetrabenazine 48 MG Extended Release Oral Tablet

24 HR deutetrabenazine 48 MG Extended Release Oral Tablet [Austedo]

Report Adverse Event 

Submit MSL Request 

Prescribing Information

Medication Guide 

Pharmacy List 

Reimbursement Information 

Formulary Information: Tardive Dyskinesia

Formulary Information: Huntingdon's Disease Chorea 

Coverage Authorization Request 

Coverage Authorization Appeals 

Letter of Medical Necessity 

Austedo Prescription & Service Request Form 

Enroll in Patient Savings Program 

Other HCP Resources: Tardive Dyskinesia 

Other HCP Resources: Huntingdon's Disease Chorea 

About Austedo: Tardive Dyskinesia 

Side Effects: Tardive Dyskinesia 

Taking Austedo: Tardive Dyskinesia 

Patient Stories: Tardive Dyskinesia 

Shared Solutions Support Program: Tardive Dyskinesia 

Doctor Discussion Guide: Tardive Dyskinesia 

Treament Tracker: Tardive Dyskinesia 

Patient Brochure: Tardive Dyskinesia 

About Austedo: Huntington's Disease Chorea 

Side Effects: Huntington's Disease Chorea 

Taking Austedo: Huntington's Disease Chorea 

Teva Shared Solutions Support Program: Huntington's Disease Chorea 

Care Partner Resources: Huntington's Disease Chorea 

Doctor Discussion Guide: Huntington's Disease Chorea 

Treatment Tracker: Huntingdon's Disease Chorea 

Patient Brochure: Huntingdon's Disease Chorea 

Instructions For Use: Tardive Dyskinesia 

Instructions For Use: Huntington's Disease Chorea 

Shared Solutions Financial Brochure

Psoriasis (PsO)

Psoriatic Arthritis (PsA)

Ankylosing Spondylitis (AS)

Nonradiographic Axial Spondyloarthritis

Taltz

Juvenile Idiopathic Arthritis

Hidradenitis Suppurativa (HS)

Cosentyx

Siliq

Tremfya

Crohn's Disease (CD)

Ulcerative Colitis (UC)

Stelara

Skyrizi

Ilumya

Migraine

Cluster Headache

Migraine Prevention

Emgality

Qulipta

Acute Migraine

Ubrelvy

Nurtec ODT

Vyepti

Aimovig

Ajovy

Breast Cancer: HR+ (HER2-)

Verzenio

Ibrance

Kisqali

Atopic Dermatitis (Eczema)

Cibinqo

Eucrisa

Asthma (injectable)

Asthma OCS Dependent

Nasal Polyposis

Eosinophilic Esophagitis (EoE)

Prurigo Nodularis

Dupixent

Opzelura

Adbry

NSCLC ALK+ OR ROS1+ Disease

Lorbrena

Alecensa

Alunbrig

NSCLC cMET Mutation

Xalkori

Rheumatoid Arthritis (RA)

Xeljanz

Uveitis

Graft Versus Host Disease (GVHD)

Orencia

COVID-19 Treatment

Alopecia Areata

Olumiant

Multiple Sclerosis (MS)

Secondary Progressive Multiple Sclerosis

Zeposia

Rinvoq

Entyvio

Cigna Corporation

Express Scripts (ESI)

OptumRx

CVS Health (Aetna)

Humana, Inc.

Blue Cross Blue Shield of Massachusetts

Molina Health Care, Inc.

Independent Health Association, Inc.

Medica Health Plans

Blue Cross Blue Shield of Michigan

Premera, Inc.

Blue Cross Blue Shield of Tennessee

Health Partners Plans

Arkansas Blue Cross Blue Shield

Medical Mutual of Ohio Corporation

Blue Cross Blue Shield of Arizona, Inc.

MVP Health Care, Inc.

Blue Cross of Idaho Health Services, Inc.

Providence Health System

PacificSource Health Plan

CVS Caremark

Highmark, Inc.

Illinois

Indiana

Arizona

Louisiana

Texas

New Mexico

New Hampshire

Minnesota

Hawaii

Colorado

Oregon

Washington

Wisconsin

prior authorization forms by payer