Deutetrabenazine
AUSTEDO
What it isDeuterated VMAT2 inhibitor with hERG blockade; tardive dyskinesia and Huntington chorea.
Why this oneDeuteration slows metabolism, producing steadier exposure and less peak sedation than tetrabenazine.
What limits itDepression and suicidality are boxed risks in Huntington disease; CYP2D6 inhibition can raise exposure and QT concern.
FDA-approved for
- Huntington chorea (2017)
- tardive dyskinesia (2017)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Chorea of Huntington's disease | Adults | 6 mg BID (12 mg/day) | individualized to chorea control/tolerability | 48 mg/day (36 mg/day if poor CYP2D6 metabolizer or on strong CYP2D6 inhibitor) |
| Tardive dyskinesia | Adults | 6 mg BID (12 mg/day) | individualized to control/tolerability | 48 mg/day (36 mg/day if poor CYP2D6 metabolizer or on strong CYP2D6 inhibitor) |
Titration Increase at weekly intervals (by 6 mg/day).
Renal Undefined
Hepatic Contraindicated in hepatic impairment.
Total daily dose must not exceed 36 mg in poor CYP2D6 metabolizers or with strong CYP2D6 inhibitors.
Instructions
- Take AUSTEDO with food; give total daily doses of 12 mg or above in two divided doses
- Swallow tablets whole; do not chew, crush, or break
- AUSTEDO XR: once daily, with or without food
- Can discontinue without tapering; if interrupted >1 week, re-titrate when resumed
- Switching from tetrabenazine: discontinue it and start the next day per conversion table
Contraindications
- Huntington's disease patients who are suicidal, or with untreated/inadequately treated depression
- Hepatic impairment
- Taking reserpine (allow ≥20 days after stopping reserpine before starting)
- MAOIs (concurrently or within 14 days)
- Taking tetrabenazine or valbenazine
Cautions
- QT prolongation; avoid in congenital long QT syndrome or arrhythmias with prolonged QT
- Neuroleptic malignant syndrome; discontinue if it occurs
- Akathisia, agitation, restlessness; parkinsonism; reduce dose or discontinue
- Sedation/somnolence may impair driving/operating machinery
- Clinical worsening (mood, cognition, rigidity, function) in Huntington's disease
- Hyperprolactinemia
Adverse reactions
- Somnolence
- Diarrhea
- Dry mouth
- Fatigue
- Nasopharyngitis and insomnia (tardive dyskinesia)
Pregnancy No adequate human data; animal data suggest possible fetal harm (stillbirths/postnatal mortality seen with tetrabenazine).
Lactation No data on presence in human milk or effects on breastfed infant.
⚠ BOXED WARNING
- Depression and suicidality in Huntington disease
Cost, est. cash$3,000–$10,000/month
Generic entry2041 est.
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilityGenerally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.
Mechanism of action: Deutetrabenazine ballicule
Open Deutetrabenazine in the interactive console ↗
Memory aids: mascots and interaction avatars
“Duel” purpose: Huntington’s and TD
involuntary tongue movements suggestive of TD
QT prolongation
