Deutetrabenazine
دوتترابنازین
🧠 Nervous SystemVMAT2 inhibitor
Market / country: 🇺🇸 USA
Austedo (US)
🧮 Dose calculator
Huntington disease chorea · Regimen source: FDA Austedo · 2.1
- • With food; 12 mg/day or more in two doses. XR once daily. Strong CYP2D6 inhibitors or poor metabolizers: max 36 mg. Switching from tetrabenazine per label Table 2. FDA Austedo · 2.1FDA Austedo · 2.2FDA Austedo · 2.3
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Huntington’s with suicidality or untreated depression; hepatic impairment; reserpine (20 days); MAOIs (14 days); tetrabenazine or valbenazine. FDA Austedo · 4
Warnings
- • Boxed warning: depression and suicidality in Huntington’s disease; contraindicated with untreated depression or suicidality. FDA Austedo · Boxed Warning
- • QT prolongation; neuroleptic malignant syndrome; akathisia and parkinsonism; sedation. FDA Austedo · 5
Formulations
- 6 mg tablet (swallow whole) — tablet 🇺🇸 USA FDA Austedo · 3
- 9 mg tablet (swallow whole) — tablet 🇺🇸 USA FDA Austedo · 3
- 12 mg tablet (swallow whole) — tablet 🇺🇸 USA FDA Austedo · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Austedo · 8.1
“Risk Summary There are no adequate data on the developmental risk associated with the use of AUSTEDO XR or AUSTEDO in pregnant women.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Austedo · 8.2
“Risk Summary There are no data on the presence of deutetrabenazine or its metabolites in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Austedo · 8.4
“Chorea associated with Huntington’s Disease and Tardive Dyskinesia The safety and effectiveness of AUSTEDO XR and AUSTEDO have not been established in pediatric patients for the treatment of chorea associated with Huntington’s disease or for the treatment of tardive dyskinesia.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Austedo · 8.5
“In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of hepatic, renal, and cardiac dysfunction, and of concomitant disease or other drug therapy.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA208082
- DailyMed (FDA label)FDA Austedo
- MedlinePlus (NIH)Deutetrabenazine
- WHO ATC/DDDN07XX16
- Darooyab (Iran)❌ None
🇮🇷 Not found in Iran list Darooyab · search
Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Austedo · 3FDA Austedo · 2.1FDA Austedo · 2.2FDA Austedo · 2.3FDA Austedo · 4FDA Austedo · Boxed WarningFDA Austedo · 5FDA Austedo · SPL approval / marketing categoryFDA Austedo · 8.1FDA Austedo · 8.2FDA Austedo · 8.4FDA Austedo · 8.5
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · search
- Clinical review⚠ Unverified