U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Details

Stereochemistry RACEMIC
Molecular Formula C19H27NO3
Molecular Weight 323.4596
Optical Activity ( + / - )
Defined Stereocenters 2 / 2
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of DEUTETRABENAZINE

SMILES

[H][C@@]12CC(=O)[C@@H](CC(C)C)CN1CCC3=CC(OC([2H])([2H])[2H])=C(OC([2H])([2H])[2H])C=C23

InChI

InChIKey=MKJIEFSOBYUXJB-WEZHFFAMSA-N
InChI=1S/C19H27NO3/c1-12(2)7-14-11-20-6-5-13-8-18(22-3)19(23-4)9-15(13)16(20)10-17(14)21/h8-9,12,14,16H,5-7,10-11H2,1-4H3/t14-,16-/m0/s1/i3D3,4D3

HIDE SMILES / InChI

Description

Deutetrabenazine (trade name Austedo) is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of chorea associated with Huntington’s disease. The drug was developed by Auspex Pharmaceuticals and is being commercialized by Teva Pharmaceuticals. Deutetrabenazine is a deuterated derivative of tetrabenazine. The incorporation of deuterium in place of hydrogen at the sites of primary metabolism results in metabolic clearance being slowed, allowing less frequent dosing and better tolerability.

CNS Activity

Originator

Approval Year

2017
422
Targets

Targets

Primary TargetPharmacologyConditionPotency
Synaptic vesicular amine transporter
57
Target ID: Q05940
Gene ID: 6571.0
Gene Symbol: SLC18A2
Target Organism: Homo sapiens (Human)
Inhibitor
8297
 3.8 nM [Ki]
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
Approved
8429
AUSTEDO

Approved Use

Austedo® is indicated for the treatment of chorea associated with Huntington’s disease

Launch Date

2017
Primary
Approved
8429
AUSTEDO

Approved Use

Austedo® is indicated for the treatment of ​tardive dyskinesia in adults

Launch Date

2017
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
0.3 ng/mL
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/32155315
25 mg single, oral
dose: 25 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
DEUTETRABENAZINE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
0.26 ng × h/mL
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/32155315
25 mg single, oral
dose: 25 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
DEUTETRABENAZINE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
Doses

Doses

DosePopulationAdverse events​
12 mg 2 times / day multiple, oral
Recommended
Dose: 12 mg, 2 times / day
Route: oral
Route: multiple
Dose: 12 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
unhealthy, 18 to 75 years
n = 298
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 18 to 75 years
Sex: M+F
Population Size: 298
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
Disc. AE: Suicidal ideation, Sudden cardiac death...
AEs leading to
discontinuation/dose reduction:
Suicidal ideation
Sudden cardiac death
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
18 mg 2 times / day multiple, oral
Recommended
Dose: 18 mg, 2 times / day
Route: oral
Route: multiple
Dose: 18 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
unhealthy, 18 to 75 years
n = 298
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 18 to 75 years
Sex: M+F
Population Size: 298
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
Disc. AE: Insomnia, Cardio-respiratory arrest...
AEs leading to
discontinuation/dose reduction:
Insomnia
Cardio-respiratory arrest
Psychomotor hyperactivity
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
6 mg 2 times / day multiple, oral
Recommended
Dose: 6 mg, 2 times / day
Route: oral
Route: multiple
Dose: 6 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
unhealthy, 18 to 75 years
n = 298
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 18 to 75 years
Sex: M+F
Population Size: 298
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
Disc. AE: QT prolonged, Vesicular rash...
AEs leading to
discontinuation/dose reduction:
QT prolonged
Vesicular rash
Psychotic disorder
Schizophrenia exacerbated
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
15 mg 2 times / day multiple, oral (mean)
Recommended
Dose: 15 mg, 2 times / day
Route: oral
Route: multiple
Dose: 15 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
unhealthy, 25 to 75 years
n = 58
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 25 to 75 years
Population Size: 58
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
Disc. AE: Confusional state...
AEs leading to
discontinuation/dose reduction:
Confusional state
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
12 mg 2 times / day multiple, oral
Recommended
Dose: 12 mg, 2 times / day
Route: oral
Route: multiple
Dose: 12 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.33
unhealthy, 32 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 32 years
Sex: F
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.33
Disc. AE: Mental status changes...
AEs leading to
discontinuation/dose reduction:
Mental status changes (grade 3, 0.8%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.33
21 mg 2 times / day multiple, oral
Dose: 21 mg, 2 times / day
Route: oral
Route: multiple
Dose: 21 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.34
unhealthy, 44 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 44 years
Sex: M
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.34
Disc. AE: Depression...
AEs leading to
discontinuation/dose reduction:
Depression (grade 1, 0.8%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.34
12 mg 2 times / day multiple, oral
Recommended
Dose: 12 mg, 2 times / day
Route: oral
Route: multiple
Dose: 12 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.22
unhealthy, 49 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 49 years
Sex: F
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.22
Disc. AE: Hypersomnia...
AEs leading to
discontinuation/dose reduction:
Hypersomnia (grade 2, 0.8%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.22
18 mg 2 times / day multiple, oral
Recommended
Dose: 18 mg, 2 times / day
Route: oral
Route: multiple
Dose: 18 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.35
unhealthy, 49 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 49 years
Sex: F
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.35
Disc. AE: Depression...
AEs leading to
discontinuation/dose reduction:
Depression (grade 2, 0.8%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.35
27 mg 2 times / day multiple, oral
Dose: 27 mg, 2 times / day
Route: oral
Route: multiple
Dose: 27 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.25
unhealthy, 51 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 51 years
Sex: M
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.25
Disc. AE: Communication disorder...
AEs leading to
discontinuation/dose reduction:
Communication disorder (grade 2, 0.8%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.25
18 mg 2 times / day multiple, oral
Recommended
Dose: 18 mg, 2 times / day
Route: oral
Route: multiple
Dose: 18 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.32
unhealthy, 53 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 53 years
Sex: F
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.32
Disc. AE: Major depression...
AEs leading to
discontinuation/dose reduction:
Major depression (grade 3, 0.8%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.32
24 mg 2 times / day multiple, oral
Dose: 24 mg, 2 times / day
Route: oral
Route: multiple
Dose: 24 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.29
unhealthy, 53 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 53 years
Sex: M
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.29
Disc. AE: Suicidal ideation...
AEs leading to
discontinuation/dose reduction:
Suicidal ideation (grade 1, 0.8%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.29
27 mg 2 times / day multiple, oral
Dose: 27 mg, 2 times / day
Route: oral
Route: multiple
Dose: 27 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.26
unhealthy, 54 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 54 years
Sex: F
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.26
Disc. AE: Cognitive disorder...
AEs leading to
discontinuation/dose reduction:
Cognitive disorder (grade 2, 0.8%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.26
27 mg 2 times / day multiple, oral
Dose: 27 mg, 2 times / day
Route: oral
Route: multiple
Dose: 27 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.22
unhealthy, 56 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 56 years
Sex: F
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.22
Disc. AE: Dysphagia...
AEs leading to
discontinuation/dose reduction:
Dysphagia (grade 2, 0.8%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.22
9 mg 2 times / day multiple, oral
Dose: 9 mg, 2 times / day
Route: oral
Route: multiple
Dose: 9 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.24
unhealthy, 56 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 56 years
Sex: M
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.24
Disc. AE: Sudden cardiac death...
AEs leading to
discontinuation/dose reduction:
Sudden cardiac death (grade 3, 0.8%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.24
21 mg 2 times / day multiple, oral
Dose: 21 mg, 2 times / day
Route: oral
Route: multiple
Dose: 21 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.31
unhealthy, 60 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 60 years
Sex: M
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.31
Disc. AE: Paranoia...
AEs leading to
discontinuation/dose reduction:
Paranoia (grade 2, 0.8%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.31
27 mg 2 times / day multiple, oral
Dose: 27 mg, 2 times / day
Route: oral
Route: multiple
Dose: 27 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.27
unhealthy, 60 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 60 years
Sex: F
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.27
Disc. AE: Chorea...
AEs leading to
discontinuation/dose reduction:
Chorea (grade 2, 0.8%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.27
15 mg 2 times / day multiple, oral
Dose: 15 mg, 2 times / day
Route: oral
Route: multiple
Dose: 15 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.28
unhealthy, 61 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 61 years
Sex: M
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.28
Disc. AE: Chorea...
AEs leading to
discontinuation/dose reduction:
Chorea (grade 3, 0.8%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.28
21 mg 2 times / day multiple, oral
Dose: 21 mg, 2 times / day
Route: oral
Route: multiple
Dose: 21 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.30
unhealthy, 62 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 62 years
Sex: M
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.30
Disc. AE: Anxiety...
AEs leading to
discontinuation/dose reduction:
Anxiety (grade 2, 0.8%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.30
36 mg 2 times / day multiple, oral
Highest studied dose
Dose: 36 mg, 2 times / day
Route: oral
Route: multiple
Dose: 36 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.36
unhealthy, 71 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 71 years
Sex: M
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.36
Disc. AE: Failure to thrive...
AEs leading to
discontinuation/dose reduction:
Failure to thrive (grade 3, 0.8%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.36
15 mg 2 times / day multiple, oral (mean)
Recommended
Dose: 15 mg, 2 times / day
Route: oral
Route: multiple
Dose: 15 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
unhealthy, mean age 5.59 years
n = 202
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: mean age 5.59 years
Sex: M+F
Population Size: 202
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
Disc. AE: Somnolence, Disturbance in attention...
AEs leading to
discontinuation/dose reduction:
Somnolence (0.3%)
Disturbance in attention (0.3%)
Anxiety (0.7%)
Insomnia (0.3%)
Depression (0.7%)
Suicide attempt (0.3%)
Homicidal ideation (0.3%)
Fatigue (0.3%)
Asthenia (0.3%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
AEs

AEs

AESignificanceDosePopulation
Sudden cardiac death Disc. AE
12 mg 2 times / day multiple, oral
Recommended
Dose: 12 mg, 2 times / day
Route: oral
Route: multiple
Dose: 12 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
unhealthy, 18 to 75 years
n = 298
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 18 to 75 years
Sex: M+F
Population Size: 298
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
Suicidal ideation Disc. AE
12 mg 2 times / day multiple, oral
Recommended
Dose: 12 mg, 2 times / day
Route: oral
Route: multiple
Dose: 12 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
unhealthy, 18 to 75 years
n = 298
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 18 to 75 years
Sex: M+F
Population Size: 298
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
Cardio-respiratory arrest Disc. AE
18 mg 2 times / day multiple, oral
Recommended
Dose: 18 mg, 2 times / day
Route: oral
Route: multiple
Dose: 18 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
unhealthy, 18 to 75 years
n = 298
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 18 to 75 years
Sex: M+F
Population Size: 298
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
Insomnia Disc. AE
18 mg 2 times / day multiple, oral
Recommended
Dose: 18 mg, 2 times / day
Route: oral
Route: multiple
Dose: 18 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
unhealthy, 18 to 75 years
n = 298
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 18 to 75 years
Sex: M+F
Population Size: 298
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
Psychomotor hyperactivity Disc. AE
18 mg 2 times / day multiple, oral
Recommended
Dose: 18 mg, 2 times / day
Route: oral
Route: multiple
Dose: 18 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
unhealthy, 18 to 75 years
n = 298
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 18 to 75 years
Sex: M+F
Population Size: 298
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
Psychotic disorder Disc. AE
6 mg 2 times / day multiple, oral
Recommended
Dose: 6 mg, 2 times / day
Route: oral
Route: multiple
Dose: 6 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
unhealthy, 18 to 75 years
n = 298
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 18 to 75 years
Sex: M+F
Population Size: 298
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
QT prolonged Disc. AE
6 mg 2 times / day multiple, oral
Recommended
Dose: 6 mg, 2 times / day
Route: oral
Route: multiple
Dose: 6 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
unhealthy, 18 to 75 years
n = 298
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 18 to 75 years
Sex: M+F
Population Size: 298
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
Schizophrenia exacerbated Disc. AE
6 mg 2 times / day multiple, oral
Recommended
Dose: 6 mg, 2 times / day
Route: oral
Route: multiple
Dose: 6 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
unhealthy, 18 to 75 years
n = 298
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 18 to 75 years
Sex: M+F
Population Size: 298
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
Vesicular rash Disc. AE
6 mg 2 times / day multiple, oral
Recommended
Dose: 6 mg, 2 times / day
Route: oral
Route: multiple
Dose: 6 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
unhealthy, 18 to 75 years
n = 298
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 18 to 75 years
Sex: M+F
Population Size: 298
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf
Page: 209885Orig1s000MedR.pdf - p.116
Confusional state Disc. AE
15 mg 2 times / day multiple, oral (mean)
Recommended
Dose: 15 mg, 2 times / day
Route: oral
Route: multiple
Dose: 15 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
unhealthy, 25 to 75 years
n = 58
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 25 to 75 years
Population Size: 58
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
Mental status changes grade 3, 0.8%
Disc. AE
12 mg 2 times / day multiple, oral
Recommended
Dose: 12 mg, 2 times / day
Route: oral
Route: multiple
Dose: 12 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.33
unhealthy, 32 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 32 years
Sex: F
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.33
Depression grade 1, 0.8%
Disc. AE
21 mg 2 times / day multiple, oral
Dose: 21 mg, 2 times / day
Route: oral
Route: multiple
Dose: 21 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.34
unhealthy, 44 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 44 years
Sex: M
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.34
Hypersomnia grade 2, 0.8%
Disc. AE
12 mg 2 times / day multiple, oral
Recommended
Dose: 12 mg, 2 times / day
Route: oral
Route: multiple
Dose: 12 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.22
unhealthy, 49 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 49 years
Sex: F
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.22
Depression grade 2, 0.8%
Disc. AE
18 mg 2 times / day multiple, oral
Recommended
Dose: 18 mg, 2 times / day
Route: oral
Route: multiple
Dose: 18 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.35
unhealthy, 49 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 49 years
Sex: F
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.35
Communication disorder grade 2, 0.8%
Disc. AE
27 mg 2 times / day multiple, oral
Dose: 27 mg, 2 times / day
Route: oral
Route: multiple
Dose: 27 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.25
unhealthy, 51 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 51 years
Sex: M
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.25
Major depression grade 3, 0.8%
Disc. AE
18 mg 2 times / day multiple, oral
Recommended
Dose: 18 mg, 2 times / day
Route: oral
Route: multiple
Dose: 18 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.32
unhealthy, 53 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 53 years
Sex: F
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.32
Suicidal ideation grade 1, 0.8%
Disc. AE
24 mg 2 times / day multiple, oral
Dose: 24 mg, 2 times / day
Route: oral
Route: multiple
Dose: 24 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.29
unhealthy, 53 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 53 years
Sex: M
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.29
Cognitive disorder grade 2, 0.8%
Disc. AE
27 mg 2 times / day multiple, oral
Dose: 27 mg, 2 times / day
Route: oral
Route: multiple
Dose: 27 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.26
unhealthy, 54 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 54 years
Sex: F
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.26
Dysphagia grade 2, 0.8%
Disc. AE
27 mg 2 times / day multiple, oral
Dose: 27 mg, 2 times / day
Route: oral
Route: multiple
Dose: 27 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.22
unhealthy, 56 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 56 years
Sex: F
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.22
Sudden cardiac death grade 3, 0.8%
Disc. AE
9 mg 2 times / day multiple, oral
Dose: 9 mg, 2 times / day
Route: oral
Route: multiple
Dose: 9 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.24
unhealthy, 56 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 56 years
Sex: M
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.24
Paranoia grade 2, 0.8%
Disc. AE
21 mg 2 times / day multiple, oral
Dose: 21 mg, 2 times / day
Route: oral
Route: multiple
Dose: 21 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.31
unhealthy, 60 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 60 years
Sex: M
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.31
Chorea grade 2, 0.8%
Disc. AE
27 mg 2 times / day multiple, oral
Dose: 27 mg, 2 times / day
Route: oral
Route: multiple
Dose: 27 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.27
unhealthy, 60 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 60 years
Sex: F
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.27
Chorea grade 3, 0.8%
Disc. AE
15 mg 2 times / day multiple, oral
Dose: 15 mg, 2 times / day
Route: oral
Route: multiple
Dose: 15 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.28
unhealthy, 61 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 61 years
Sex: M
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.28
Anxiety grade 2, 0.8%
Disc. AE
21 mg 2 times / day multiple, oral
Dose: 21 mg, 2 times / day
Route: oral
Route: multiple
Dose: 21 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.30
unhealthy, 62 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 62 years
Sex: M
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.30
Failure to thrive grade 3, 0.8%
Disc. AE
36 mg 2 times / day multiple, oral
Highest studied dose
Dose: 36 mg, 2 times / day
Route: oral
Route: multiple
Dose: 36 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.36
unhealthy, 71 years
n = 119
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: 71 years
Sex: M
Population Size: 119
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208082Orig1s000MedR.pdf
Page: 208082Orig1s000MedR.pdf - p.36
Asthenia 0.3%
Disc. AE
15 mg 2 times / day multiple, oral (mean)
Recommended
Dose: 15 mg, 2 times / day
Route: oral
Route: multiple
Dose: 15 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
unhealthy, mean age 5.59 years
n = 202
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: mean age 5.59 years
Sex: M+F
Population Size: 202
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
Disturbance in attention 0.3%
Disc. AE
15 mg 2 times / day multiple, oral (mean)
Recommended
Dose: 15 mg, 2 times / day
Route: oral
Route: multiple
Dose: 15 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
unhealthy, mean age 5.59 years
n = 202
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: mean age 5.59 years
Sex: M+F
Population Size: 202
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
Fatigue 0.3%
Disc. AE
15 mg 2 times / day multiple, oral (mean)
Recommended
Dose: 15 mg, 2 times / day
Route: oral
Route: multiple
Dose: 15 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
unhealthy, mean age 5.59 years
n = 202
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: mean age 5.59 years
Sex: M+F
Population Size: 202
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
Homicidal ideation 0.3%
Disc. AE
15 mg 2 times / day multiple, oral (mean)
Recommended
Dose: 15 mg, 2 times / day
Route: oral
Route: multiple
Dose: 15 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
unhealthy, mean age 5.59 years
n = 202
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: mean age 5.59 years
Sex: M+F
Population Size: 202
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
Insomnia 0.3%
Disc. AE
15 mg 2 times / day multiple, oral (mean)
Recommended
Dose: 15 mg, 2 times / day
Route: oral
Route: multiple
Dose: 15 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
unhealthy, mean age 5.59 years
n = 202
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: mean age 5.59 years
Sex: M+F
Population Size: 202
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
Somnolence 0.3%
Disc. AE
15 mg 2 times / day multiple, oral (mean)
Recommended
Dose: 15 mg, 2 times / day
Route: oral
Route: multiple
Dose: 15 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
unhealthy, mean age 5.59 years
n = 202
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: mean age 5.59 years
Sex: M+F
Population Size: 202
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
Suicide attempt 0.3%
Disc. AE
15 mg 2 times / day multiple, oral (mean)
Recommended
Dose: 15 mg, 2 times / day
Route: oral
Route: multiple
Dose: 15 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
unhealthy, mean age 5.59 years
n = 202
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: mean age 5.59 years
Sex: M+F
Population Size: 202
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
Anxiety 0.7%
Disc. AE
15 mg 2 times / day multiple, oral (mean)
Recommended
Dose: 15 mg, 2 times / day
Route: oral
Route: multiple
Dose: 15 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
unhealthy, mean age 5.59 years
n = 202
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: mean age 5.59 years
Sex: M+F
Population Size: 202
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
Depression 0.7%
Disc. AE
15 mg 2 times / day multiple, oral (mean)
Recommended
Dose: 15 mg, 2 times / day
Route: oral
Route: multiple
Dose: 15 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
unhealthy, mean age 5.59 years
n = 202
Health Status: unhealthy
Condition: Tardive dyskinesia
Age Group: mean age 5.59 years
Sex: M+F
Population Size: 202
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209885Orig1s000OtherR.pdf
Page: 209885Orig1s000OtherR.pdf - p.28 | 209885Orig1s000SumR.pdf - p.5
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG
inducer
781
inhibitor
1767
substrate
1217

inhibitor
1852

OverviewOther

Other InhibitorOther SubstrateOther Inducer
CYP1A2
1524

CYP2B6
810

CYP2C8
911

CYP2C19
1478

CYP3A4/5
278

P-gp
1461

BCRP
699

OATP1B1
788

OATP1B3
706

OCT2
647

OAT1
599

OAT3
642
carbonyl reductase
1

CYP1A2
1054

OAT3
339

P-gp
1537

BCRP
561

OATP1B1
406

OATP1B3
350

OCT2
355

OAT1
326
CYP1A2
701

CYP2B6
547
Drug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
BCRP
773
 no
SD-1018
1
BCRP
773
 no
SD-1021
1
CYP1A2
1692
 no
SD-1018
1
CYP1A2
1692
 no
SD-1021
1
CYP1A2
1692
 no
SD-1018
1
CYP1A2
1692
 no
SD-1021
1
CYP2B6
1001
 no
SD-1018
1
CYP2B6
1001
 no
SD-1018
1
CYP2B6
1001
 no
SD-1021
1
CYP2C19
1553
 no
SD-1018
1
CYP2C19
1553
 no
SD-1021
1
CYP2C8
965
 no
SD-1018
1
CYP2C8
965
 no
SD-1021
1
CYP2C9
1819
 no
SD-1018
1
CYP2C9
1819
 no
SD-1021
1
CYP2D6
1891
 no
SD-1018
1
CYP2D6
1891
 no
SD-1021
1
CYP3A4/5
335
 no
SD-1018
1
CYP3A4/5
335
 no
SD-1021
1
OAT1
603
 no
SD-1021
1
OAT3
644
 no
SD-1018
1
OAT3
644
 no
SD-1021
1
OATP1B1
803
 no
SD-1018
1
OATP1B1
803
 no
SD-1021
1
OATP1B3
715
 no
SD-1018
1
OATP1B3
715
 no
SD-1021
1
OCT2
648
 no
SD-1021
1
P-gp
1650
 no
SD-1018
1
P-gp
1650
 no
SD-1021
1
OAT1
603
 weak [Inhibition 20 uM]
SD-1018
1
OCT2
648
 weak [Inhibition 20 uM]
SD-1018
1
CYP2B6
1001
 yes
SD-1021
1
CYP3A4
1925
 yes
SD-1018
1
CYP3A4
1925
 yes
SD-1021
1
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
CYP2D6
1217
 major
yes (co-administration study)
Comment: An in vivo drug-drug interaction (DDI) study conducted with SD-809, showed a 3-fold increase in total (α+β)-HTBZ exposures when a strong CYP2D6 inhibitor (paroxetine) was co-administered with SD-809.
Page: 4.0
BCRP
561
 no
SD-1018
1
BCRP
561
 no
SD-1021
1
OAT1
326
 no
SD-1018
1
OAT1
326
 no
SD-1021
1
OAT3
339
 no
SD-1018
1
OATP1B1
406
 no
SD-1018
1
OATP1B1
406
 no
SD-1021
1
OATP1B3
350
 no
SD-1018
1
OATP1B3
350
 no
SD-1021
1
OCT2
355
 no
SD-1018
1
OCT2
355
 no
SD-1021
1
P-gp
1537
 no
SD-1018
1
P-gp
1537
 no
SD-1021
1
CYP1A2
1054
 yes
OAT3
339
 yes
SD-1021
1
carbonyl reductase
1
 yes
PubMed

PubMed

TitleDatePubMed
Breakthrough drugs for the interface between psychiatry and neurology.
2016 Apr
Effect of Deutetrabenazine on Chorea Among Patients With Huntington Disease: A Randomized Clinical Trial.
2016 Jul 5
Deutetrabenazine for Treatment of Chorea in Huntington Disease.
2016 Jul 5
Patents

Patents

US20170087147
1

Sample Use Guides

In Vivo Use Guide
​The dose of Austedo is determined individually for each patient based on the reduction of chorea or tardive dyskinesia and tolerability. When first prescribed to patients who are not being switched from tetrabenazine (a related VMAT2 inhibitor), the recommended starting dose of Austedo is 6 mg administered orally once daily for patients with Huntington’s disease and 12 mg per day (6 mg twice daily) for patients with tardive dyskinesia.
Route of Administration: Oral
In Vitro Use Guide
The in vitro binding affinity for the active metabolites of tetrabenazine (α- and β- dihydrotetrabenazine) and the deuterated versions of these metabolites to the vesicular monoamine transporter 2 (VMAT2) was examined in competitive binding assays. Deuterated α-dihydrotetrabenazine binds to VMAT2 with Ki of 3.8 nM, non-deuterated α-dihydrotetrabenazine binds with Ki of 3.1 nM.
Name Type Language
DEUTETRABENAZINE
DASH   INN   USAN   WHO-DD  
USAN   INN  
Official Name English
DEUTETRABENAZINE [ORANGE BOOK]
Common Name English
(3RS,11bRS)-9,10-Di([2H3]methoxy)-3-(2-methylpropyl)-1,3,4,6,7,11b-hexahydro-2H-benzo[a]quinolizin-2-one
Systematic Name English
AUSTEDO
Brand Name English
Deutetrabenazine [WHO-DD]
Common Name English
SD-809
Code English
deutetrabenazine [INN]
Common Name English
DEUTETRABENAZINE [USAN]
Common Name English
2H-BENZO(A)QUINOLIZIN-2-ONE, 1,3,4,6,7,11B-HEXAHYDRO-9,10-DI(METHOXY-D3)-3-(2-METHYLPROPYL)-, (3R,11BR)-REL-
Systematic Name English
Classification Tree Code System Code
FDA ORPHAN DRUG 383212
Created by admin on Sat Dec 16 07:53:41 GMT 2023 , Edited by admin on Sat Dec 16 07:53:41 GMT 2023
FDA ORPHAN DRUG 442314
Created by admin on Sat Dec 16 07:53:41 GMT 2023 , Edited by admin on Sat Dec 16 07:53:41 GMT 2023
Code System Code Type Description
FDA UNII
P341G6W9NB
Created by admin on Sat Dec 16 07:53:41 GMT 2023 , Edited by admin on Sat Dec 16 07:53:41 GMT 2023
PRIMARY
NCI_THESAURUS
C174828
Created by admin on Sat Dec 16 07:53:41 GMT 2023 , Edited by admin on Sat Dec 16 07:53:41 GMT 2023
PRIMARY
PUBCHEM
73442840
Created by admin on Sat Dec 16 07:53:41 GMT 2023 , Edited by admin on Sat Dec 16 07:53:41 GMT 2023
PRIMARY
SMS_ID
100000164892
Created by admin on Sat Dec 16 07:53:41 GMT 2023 , Edited by admin on Sat Dec 16 07:53:41 GMT 2023
PRIMARY
CAS
1392826-25-3
Created by admin on Sat Dec 16 07:53:41 GMT 2023 , Edited by admin on Sat Dec 16 07:53:41 GMT 2023
PRIMARY
DRUG BANK
DB12161
Created by admin on Sat Dec 16 07:53:41 GMT 2023 , Edited by admin on Sat Dec 16 07:53:41 GMT 2023
PRIMARY
WIKIPEDIA
Deutetrabenazine
Created by admin on Sat Dec 16 07:53:41 GMT 2023 , Edited by admin on Sat Dec 16 07:53:41 GMT 2023
PRIMARY
RXCUI
1876905
Created by admin on Sat Dec 16 07:53:41 GMT 2023 , Edited by admin on Sat Dec 16 07:53:41 GMT 2023
PRIMARY
USAN
AB-116
Created by admin on Sat Dec 16 07:53:41 GMT 2023 , Edited by admin on Sat Dec 16 07:53:41 GMT 2023
PRIMARY
DAILYMED
P341G6W9NB
Created by admin on Sat Dec 16 07:53:41 GMT 2023 , Edited by admin on Sat Dec 16 07:53:41 GMT 2023
PRIMARY
EVMPD
SUB179485
Created by admin on Sat Dec 16 07:53:41 GMT 2023 , Edited by admin on Sat Dec 16 07:53:41 GMT 2023
PRIMARY
DRUG CENTRAL
5226
Created by admin on Sat Dec 16 07:53:41 GMT 2023 , Edited by admin on Sat Dec 16 07:53:41 GMT 2023
PRIMARY
EPA CompTox
DTXSID601027934
Created by admin on Sat Dec 16 07:53:41 GMT 2023 , Edited by admin on Sat Dec 16 07:53:41 GMT 2023
PRIMARY
INN
10069
Created by admin on Sat Dec 16 07:53:41 GMT 2023 , Edited by admin on Sat Dec 16 07:53:41 GMT 2023
PRIMARY
METABOLITE ACTIVE (PARENT)
Structure of D6-.ALPHA.-DIHYDROTETRABENAZINE
METABOLITE ACTIVE (PARENT)
Structure of D6-.BETA.-DIHYDROTETRABENAZINE
NIH
NCATS
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