RYSTIGGO: selected primary-label renal guidance and limits
What matters first
Product: Adult RYSTIGGO subcutaneous infusion for labeled generalized myasthenia gravis; not intravenous administration.
- Renal action / finding
- Label: no renal adjustment required.
- Evidence or dialysis limit
- Evidence is population PK, not a dedicated severe-renal or dialysis study.
- Monitoring / application
- Subcutaneous infusion only; use the labeled weight-based regimen.
- Product / population
- Adult RYSTIGGO subcutaneous infusion for labeled generalized myasthenia gravis; not intravenous administration.
- Renal measure
- Population PK: indexed eGFR 38-161 mL/min/1.73 m2
- Source revision
- Revision date not captured in selected review; retrieval date is not revision date.
- Retrieved
- 2026-11-07 (not the revision date)
Evidence is population PK, not a dedicated severe-renal or dialysis study.
Selected renal section, not a complete prescribing monograph. A label and its mirror are not independent evidence.
Section 12.3, Patients with Renal Impairment
The label states no dose adjustment is required with renal impairment. No dedicated renal PK study was performed; population data included mild/moderate impairment, with eGFR 38-161 mL/min/1.73 m2. This explicit instruction is retained without claiming that severe impairment or dialysis was directly validated.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3c0eb8c2-c042-4954-b451-3baa77f5e6d1
