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Austedo
deutetrabenazine
Black Box Warnings .
Depression and Suicidality
incr. risk of depression and suicidality in pts w/ Huntington dz, esp. if depression hx or prior suicide attempts or ideation; weigh risk vs. benefit; observe all pts for new or worsening depression, suicidality, or unusual behavior changes; inform pts and caregivers of depression and suicidality risk and instruct to report any concerning behaviors; contraindicated if actively suicidal or if untreated/inadequately treated depression
Adult Dosing .
Dosage forms: TAB: 6 mg, 9 mg, 12 mg
Restricted Distribution in US
- [1-800-887-8100 or www.austedo.com for more info]
chorea, Huntington dz-associated
- [12-48 mg/day PO divided bid]
- Start: 6 mg PO bid, then may incr. by 6 mg/day qwk; Max: 48 mg/day; Info: give w/ food; max 36 mg/day in CYP2D6 poor metabolizers; retitrate if tx interrupted for >1wk; do not cut/crush/chew tab; see pkg insert for conversion from tetrabenazine
tardive dyskinesia
- [12-48 mg/day PO divided bid]
- Start: 6 mg PO bid, then may incr. by 6 mg/day qwk; Max: 48 mg/day; Info: give w/ food; max 36 mg/day in CYP2D6 poor metabolizers; retitrate if tx interrupted for >1wk; do not cut/crush/chew tab; see pkg insert for conversion from tetrabenazine
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- hepatic impairment: contraindicated
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.