Deutetrabenazine tablets (Austedo / Austedo XR) - selected U.S. label sections
- Product / population
- AUSTEDO and AUSTEDO XR oral products; this comment does not create a dose conversion between them.
- Renal measure
- No renal-function dosing study described in the selected section.
Selected renal sections only, not a complete monograph. Exact product, indication, patient population, renal method and all other contraindications/interactions remain controlling.
Second independent renal reference and clinician adjudication remain pending; no all-indication, dialysis or pediatric dose may be inferred from an omitted field.
Renal evidence gap
The effect of renal impairment on the pharmacokinetics of deutetrabenazine and its primary metabolites has not been studied. A validated renal dose or dialysis regimen cannot be derived from that absence of studies.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7ea3c60a-45c7-44cc-afc2-d87fa53993c0