SOTYKTU: selected primary-label renal guidance and limits
What matters first
Product: Adult oral SOTYKTU for its labeled indications; renal instruction does not waive other eligibility and safety requirements.
- Renal action / finding
- No renal adjustment, including ESRD on dialysis.
- Evidence or dialysis limit
- No CRRT settings or modality-specific schedule supplied in the selected section.
- Monitoring / application
- Use the explicit renal paragraph; do not use the malformed RX PK range.
- Product / population
- Adult oral SOTYKTU for its labeled indications; renal instruction does not waive other eligibility and safety requirements.
- Renal measure
- Qualitative renal categories, explicitly including ESRD on dialysis
- Source revision
- Revision date not captured in selected review; retrieval date is not revision date.
- Retrieved
- 2026-11-07 (not the revision date)
No CRRT settings or modality-specific schedule supplied in the selected section.
Selected renal section, not a complete prescribing monograph. A label and its mirror are not independent evidence.
Section 8.6
No dose adjustment is recommended for mild, moderate or severe renal impairment, or ESRD on dialysis. This is an explicit renal-use instruction, not a newly derived exposure-based dose. The selected section does not specify CRRT settings. Review the full label for infection and other safety restrictions.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ff4d7258-5068-4cdf-9692-8cae04c3198e
